PEER REVIEWED

Evaluation of Validation
Content Uniformity Test
Results Using Lower
Probability Bound
Distribution Charts
Pramote Cholayudth

INTRODUCTION a good approach like J.S. Bergum’s method if the

One of the widely recognized references on process
validation with regard to sampling and testing plans
is the US Food and Drug Administration’s Draft Guid-
ance for Industry: Powder Blends and Finished Dosage
Units—Stratified In-Process Dosage Unit Sampling and
Assessment (1) that is based on the Product Quality Re-
search Institute (PQRI)’s Recommendation Report (2).
However, it is a non-binding document (i.e., the in-
dustry may use any alternative approaches even after
it becomes the official guidance). Another well-known
relevant reference is the PDA Technical Report No. 25:
Blend Uniformity Analysis: Validation and In-Process Test-
ing (3). The sampling, testing, and corresponding ac-
ceptance criteria limits in validation study will follow
these two statistics-based documents. The validation
test results with respect to critical quality attributes
(CQAs) require to be statistically evaluated (e.g., esti-
mating confidence limits as appropriate, demonstrat-
ing the high probability of passing the tests, etc.).
According to Torbeck (4), “… If statistical proce-
dures were given in the USP, companies would have
little incentive to develop better procedures.” His com-
ment is now reconfirmed. The industry may not have
United States Pharmacopeia (USP) provided some
kind of statistical procedures. Bergum is one of the
leading professionals who suggested the use of the new
statistical procedures. His methods (5, 6) introduced
both how to establish the validation acceptance crite-
ria and how to evaluate the validation test results. In
protocol development, all the validation practitioners
may follow some recognized documents including
Bergum’s in establishing the acceptance criteria lim-
its. However some of them may not be confident in
using statistical tools for evaluation of the test results,
especially for the multiple stage tests (e.g., content uni-
formity and dissolution).
To provide an alternative to such a statistical evalu-
ation, this article introduces an approach to using lower
probability bound distribution charts, constructed ac-
cording to Bergum’s methods, for evaluation of con-
tent uniformity test results.
USP TEST ACCEPTANCE CRITERIA
The two USP content uniformity tests may be summa-
rized in Tables I and II.

[
For more Author
information,
go to
ivthome.com/bios
ABOUT THE AUTHOR
Pramote Cholayudth is a validation consultant to Biolab in Thailand and executive director of Valitech, a well-
established GMP and validation service firm to the pharmaceutical industry. He is a guest speaker on process validation
to the industry organized by local FDA. He can be contacted by e-mail at cpramote2000@yahoo.com.

JOURNAL OF VALIDATION TECHNOLOGY [SPRING 2008] 67

PEER REVIEWED

Table I: Current USP uniformity of dosage units: Test acceptance criteria.

USP Criteria Stage 1: Assay 10 units. USP Criteria Stage 2: Assay 20 additional units.
Pass if the following criteria are met. Pass if, for all 30 units, the following criteria are met.

1) Relative standard deviation (RSD) is not more 1) Relative standard deviation (RSD) is not more than 7.8%
than 6.0% (n = 10) (n = 30)
2) Not more than c unit(s) is outside 85 – 115% label 2) Not more than c unit(s) is outside 85 – 115% label claim
claim (LC) and no unit is outside 75 – 125% LC (LC) and no unit is outside 75 – 125% LC where c = 1 for
where c = 0 for tablet and 1 for capsule tablet and 3 for capsule

Table II: New USP uniformity of dosage

units: Test acceptance criteria.
USP Criteria Stage 1: USP Criteria Stage 2:
Assay 10 units. Pass if the Assay 20 additional units.
following criteria are met. Pass if, for all 30 units, the
following criteria are met.

1. 1.
2. Xmin > 0.75M and
Xmax < 1.25M
Where M = reference value, s = standard deviation,
5 content uniformity data mean, Xmin 5 minimum and
Xmax 5 maximum (individual values)

Acceptance Value (AV) = 1 ks < L1, k = 2.4

(n 5 10) and 2.0 (n = 30),
Xmin > (1 2 L2* 0.01)M, Xmax < (1 1 L2*0.01)M
If not specified in individual monographs, L1 5 15 and
L2 5 25

Table III: New USP uniformity of dosage units:

Reference value criteria.
Case Subcase M AV
98.5 < < 101.5 ks
Target (T) < 101.5 % of
< 98.5 98.5 98.5 2 1 ks
label claim (% LC)
> 101.5 101.5 2 101.5 1 ks
98.5 < <T ks
Target (T) > 101.5 % LC < 98.5 98.5 98.5 2 1 ks
>T T 2 T 1 ks

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To help understand the new USP test acceptance cri-
teria, a scenario for calculation of acceptance value
(AV) is introduced: In a new USP content uniformity
testing, the stage 1 test results (n = 10) are mean = 101.2
% of label claim (LC) and standard deviation (SD) =
4.15 % LC. The manufacturing target is 102.5 % LC.
The acceptance value is (101.2-101.2) + 2.4x4.15 = 9.96
(< 15), so the AV limit is met.
PROBABILITY OF PASSING THE CURRENT
CONTENT UNIFORMITY TEST
According to Bergum’s method described in “Use of
the Bergum Method and MS Excel to Determine the
Probability of Passing the USP Content Uniformity
Test” (7), the probability formulae are illustrated in
Table IV. The formulae in Tables IV, XIV, and XV may
be copied to construct the Microsoft Excel file for com-
puting the probability. However, note that the sample
is taken in accordance with sampling plan 1 (one unit
from each of 30 locations).
PROBABILITY OF PASSING THE NEW
CONTENT UNIFORMITY TEST
The article “Using Bergum’s New Method and MS Excel
to Determine the Probability of Passing the New ICH
USP 29 Content Uniformity Test” (8), has the formu-
lae as illustrated in Table V. The readers may copy the
formulae in Tables V, VI, and VII to construct the Mi-
crosoft Excel file. Also note that the sample is taken in
accordance with sampling plan 1.

Table IV: MS Excel formula sheet1: Current USP test.

Excel Formula Sheet1
A B C D E F
1 Confidence Level (%) 95 Overall Bound Results
2 Sample Size (n) 30 Tablet Capsule
3 Sample Mean (% LC) 98.00 LB Prob 96.50% LB Prob 99.96%
4 Sample RSD (%) 3.50 Prob1 99.90% Prob1 100.00%
5 UB: Mean (% LC) 99.93 Prob2 96.50% Prob2 99.96%

6 LB: Mean (% LC) 96.07 Prob at UB: Mean

7 UB: SD (% LC) 4.74 Part 1/1 89.08%

8 Part 2/1 100.00%

9 Prob at LB: Mean

10 Part 1/2 84.63%

11 Part 2/2 99.96%

UB: Upper Bound, LB: Lower Bound, UB & LB formulae are as below:
B5 =B3+B7*NORMSINV(1-(1-(B1/100)^0.5)/2)/B2^0.5
B6 =B3-B7*NORMSINV(1-(1-(B1/100)^0.5)/2)/B2^0.5
B7 =B4*(B3/100)*((B2-1)/(CHIINV((B1/100)^0.5,B2-1)))^0.5
The cells B1 – B4 are entered with sample data. The numerical results in the other cells, including those in D3 and F3, are generated using the formulae in Tables
XIV and XV. The Excel file (as a combination of tables IV, XIV, and XV) can be downloaded from www.pharmtech.com – search “Pramote”.

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Table V: Microsoft Excel formula sheet1: New USP test.

Excel Formula Sheet1
Formula Examples
A B C D
1 UB: Mean 99.93 UB: SD 4.74 B1 =C22, D1 =C24
2 Stage 1 (n = 10) Stage 2 (n = 30) —
3 I1 63.19% I1 91.62% See formulae below (B3 & D3)
4 I2 12.93% I2 3.52% B4 =Sheet2!B36, D4 =Sheet2!D36
5 I3 14.73% I3 4.86% B5 =Sheet2!C36, D5 =Sheet2!E36
6 P(S1) 90.85% P(S2) 99.99% B6 =SUM(B3:B5), D6 (See below)
7 Probability 99.99% C7 =MAX(B6,D6)
8 LB: Mean 96.07 UB: SD 4.74 B8 =C23, D8 =C24
9 Stage 1 (n = 10) Stage 2 (n = 30) —
10 I1 4.81% I1 0.24% B10, D10: Follow formulae for B3 & D3
11 I2 0.01% I2 0.00% B11 =Sheet3!B36, D11 =Sheet3!D36
12 I3 64.67% I3 97.74% B12 =Sheet3!C36, D12 =Sheet3!E36
13 P(S1) 69.50% P(S2) 97.90% B13 =SUM(B10:B12), D13 (See below)
14 Probability 97.90% C14 =MAX(B13,D13)
15 Lbound Probability 97.90% C15 =MIN(C7,C14)
16 Sample Data C22 =C20+C24*NORMSINV(1-(1-
17 Target 100 0.95^0.5)/2)/C19^0.5
18 Confidence Level (%) 95 C23 =C20-C24*NORMSINV(1-(1-
19 Sample Size (n) 30 0.95^0.5)/2)/C19^0.5
20 Sample Mean (% LC) 98.00 C24 =(C20*C21/100)*((C19-1)/(CHI-
21 Sample RSD (%) 3.60 INV(0.95^0.5,C19-1)))^0.5
22 Upper Bound: Mean 99.93 Linked to B1 & Sheet2!B2
23 Lower Bound: Mean 96.07 Linked to B8 & Sheet3!B2
24 Upper Bound: SD 4.74 Linked to D1,D8,Sheet2!C2,&Sheet3!C2
B3 =(NORMSDIST((10^0.5)*(100-B1)/D1)-NORMSDIST((10^0.5)*(98.5-B1)/D1))*(1-CHIDIST((10-1)*(15/(2.4*D1))^2,10-1)) = 63.19%
(For B10, replace B1 with B8 and D1 with D8)
D3 =(NORMSDIST((30^0.5)*(100-B1)/D1)-NORMSDIST((30^0.5)*(98.5-B1)/D1))*(1-CHIDIST((30-1)*(15/(2*D1))^2,30-1)) = 91.62%
(For D10, replace B1 with B8 and D1 with D8)
D6 =MAX(SUM(D3:D5)+((NORMSDIST((123.125-B1)/D1)-NORMSDIST((IF(C17<=101.5,101.5,C17)-24.625-B1)/D1))^30)-1,0)
D13 =MAX(SUM(D10:D12)+((NORMSDIST((123.125-B8)/D8)-NORMSDIST((IF(C17<=101.5,101.5,C17)-24.625-B8)/D8))^30)-1,0)

The cells C17 – C21 are entered with sample data information. The numerical results in the other cells, including the probability and
LB results in C7, C14, and C15, are generated by the program.

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Table VI: MS Excel formula sheet2: New USP test.

Excel Formula Sheet2
Formula Examples
A B C D E
1 Target UB: Mean UB: SD h i
2 100 99.93 4.74 0.5 1 ➔ 30
3 — Stage 1 Stage 2
4 — 10 30
B6 =(NORMSDIST((B4^0.5)*((101.5+A6*D2)-
5 i I2 I3 I2 I3 B2)/C2)-NORMSDIST((B4^0.5)*((101.5+(A6-
6 1 5.85% 0.00% 2.67% 0.00% 1)*D2)-B2)/C2))*(1-CHIDIST((B4-1)*(15-(A6-
7 2 3.58% 0.00% 0.70% 0.00% 0.5)*D2)^2/(2.4*C2)^2,B4-1)) = 5.85%

8 3 1.95% 0.00% 0.13% 0.00% B35

9 4 0.94% 0.00% 0.02% 0.00% =(NORMSDIST((B4^0.5)*((101.5+A35*D2)-
10 5 0.40% 0.00% 0.00% 0.00% B2)/C2)-NORMSDIST((B4^0.5)*((101.5+(A35-
1)*D2)-B2)/C2))*(1-CHIDIST((B4-1)*(15-(A35-
11 ➔ 30 6 ➔ 25 ... ➔ ...% ... ➔ ...% ... ➔ ...% ... ➔ ...%
0.5)*D2)^2/(2.4*C2)^2,B4-1)) = 0.00%
31 26 0.00% 0.49% 0.00% 0.00%
32 27 0.00% 1.13% 0.00% 0.03% B36 =SUM(B6:B35) = 12.93%
33 28 0.00% 2.28% 0.00% 0.21%
34 29 0.00% 4.08% 0.00% 1.02%
35 30 0.00% 6.47% 0.00% 3.59%
36 Sum 12.93% 14.73% 3.52% 4.86%
The number of intervals (i) 30 with interval width (h) 0.5 is selected to ensure that the integration result,
especially when using the higher sigma values, is valid.
The stage 2 formula is similar except for n = 30 (B4 ➔ D4) and k = 2.0 (2.4 ➔ 2).
The Target (also Mean and Sigma) value is linked from Sheet1 e.g. A2 =Sheet1!B2.
And I2 (B36 & D36) and I3 (C36 & E36) are linked to Sheet1 e.g., B4 (of Sheet1) =Sheet2!B36

When sample data (n = 30) associated with sample
mean: 98% LC and sample RSD: 3.6% are plotted, the
lower probability bound distributions can be con-
structed and illustrated in Figures 1 and 2. In these fig-
ures, one can imagine how a sample data comprising
a mean and relative standard deviation (RSD) values
will influence the probability of passing a content uni-
formity test. Furthermore, the way in which a larger
sample size influences the distribution patterns is
demonstrated in Figure 3.
JUSTIFICATION OF USING THE
PROBABILITY CHARTS
Validation content uniformity test results must be eval-
uated for probability of passing the test. The evalua-
tion employs Bergum’s methods by using statistical
programs like SAS or Microsoft Excel. To provide a
practical tool as an alternative to such complicated
methods, the distribution curves for lower probability
bounds constructed in a high precision scale are intro-
duced so that validation practitioners can use them to
determine the probability instead of using the pro-
grams. However one must realize that the use of Excel
for validation work requires validation of the spread-
sheet itself (e.g., Tables IV, V, VI, and VII).

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Table VII: MS Excel Formula Sheet3: New USP Test.

Excel Formula Sheet3
Formula Examples
A B C D E
1 Target LB: Mean UB: SD h i
2 100 96.07 4.74 0.5 1 ➔ 30
3 — Stage 1 Stage 2
4 — 10 30
B6 =(NORMSDIST((B4^0.5)*((101.5+A6*D2)-
5 i I2 I3 I2 I3 B2)/C2)-NORMSDIST((B4^0.5)*((101.5+(A6-
6 1 0.01% 0.00% 0.00% 0.00% 1)*D2)-B2)/C2))*(1-CHIDIST((B4-1)*(15-(A6-
7 2 0.00% 0.00% 0.00% 0.00% 0.5)*D2)^2/(2.4*C2)^2,B4-1)) = 0.01%

8 3 0.00% 0.00% 0.00% 0.00% B35

9 4 0.00% 0.00% 0.00% 0.00% =(NORMSDIST((B4^0.5)*((101.5+A35*D2)-
10 5 0.00% 0.00% 0.00% 0.00% B2)/C2)-NORMSDIST((B4^0.5)*((101.5+(A35-
1)*D2)-B2)/C2))*(1-CHIDIST((B4-1)*(15-(A35-
11 ➔ 30 6 ➔ 25 ... ➔ ...% ... ➔ ...% ... ➔ ...% ... ➔ ...%
0.5)*D2)^2/(2.4*C2)^2,B4-1)) = 0.00%
31 26 0.00% 9.80% 0.00% 22.13%
32 27 0.00% 9.54% 0.00% 16.74% B36 =SUM(B6:B35) = 0.01%
33 28 0.00% 8.21% 0.00% 9.13%
34 29 0.00% 6.25% 0.00% 3.59%
35 30 0.00% 4.22% 0.00% 1.02%
36 Sum 0.01% 64.67% 0.00% 97.74%
The Target value (also Mean and Sigma) is linked from Sheet1 e.g., A2 =Sheet1!B2. And I2 (B36 & D36) and I3 (C36 & E36) are linked to Sheet1
e.g., B11 (of Sheet1) =Sheet3!B36

Figure 1: Operating Characteristic

Operating Characteristic (OC)
(OC) Curves
Curves for Content.
for USP USP Content uniformity tests (n = 30)

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Figure 2: Distribution Curves for Probability of Passing USP Content Uniformity Test (n=30).

Figure 3: Distribution Curves for Probability of Passing USP Content Uniformity Test (n = 70).

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tablet product tested using the current USP content
uniformity test with sample mean = 100.15% LC and
RSD = 3.9%, is performed by determining on Figure
4 the intersection of the curves for mean = 100.2
(rounded up) and RSD = 3.9. The point will indicate
the lower probability bound of approximately 97%.
The probability generated using the Excel program is
97.46%. The determined value deviates slightly from
the computed one.
Figure 4: Determining Probability Using the Probability Charts (n = 30).
P R A M O T E C H O L AY U D T H
To justify the use of probability charts is to justify
such deviations, so analysis of the deviation data in
Tables VIII, IX, and X is carried out. Each numerical
value of mean and RSD is intended to provide the sec-
ond decimal digits with 4, 5, or 6 (e.g., 97.04, 4.25,
97.06) so that when the numbers are rounded up, the
maximized deviation in the probability determination
result is challenged. The results are satisfactory since
most of the deviations are close to or equal to the cal-
culated results except for those data sets with means
greater than the target (> 100% LC) and RSDs with the
second decimals with 4, 5, or 6 where the maximum
biases (deviation) will occur. In the worst case, the
maximum deviation is 5.3% (Table IX) or 4.6% (Table
X). Therefore, the use of these types of probability charts
should be justified.
JOURNAL OF VALIDATION TECHNOLOGY [SPRING 2008] 9
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Table VIII: Comparison of Excel and Determination Results,

Current CU Test (n=30).
Tablet Capsule
Mean
RSD (%)
(% LC) Prob Excel (%) Prob Deter. (%) Deviation (%) Prob Excel (%) Prob Deter. (%) Deviation (%)

97.00 4.20 68.57 69 0.00 96.70 97 0.00

97.04 4.24 67.08 69 1.49 96.26 97 0.44
97.05 4.25 66.70 65 1.92 96.14 95 0.66
97.06 4.26 66.32 65 1.54 96.01 95 0.53
97.10 4.30 64.78 65 0.00 95.48 95 0.00
102.90 4.20 58.04 58 0.00 93.95 94 0.00
102.94 4.24 55.09 58 2.95 92.84 94 1.11
102.95 4.25 54.35 51 3.70 92.54 91 1.62
102.96 4.26 53.61 51 2.96 92.24 91 1.32
103.00 4.30 50.65 51 0.00 90.92 91 0.00

Table IX: Comparison of Excel and Determination Results,

New CU Test (n = 30).
Mean RSD Prob Prob Deviation Mean RSD Prob Excel Prob Deter. Deviation
(% LC) (%) Excel (%) Deter. (%) (%) (% LC) (%) (%) (%) (%)
97.00 3.90 79.19 79 0.00 102.90 3.90 65.12 65 0.00
97.04 3.94 77.32 79 1.87 102.94 3.94 60.98 65 4.14
97.05 3.95 76.85 74 2.45 102.95 3.95 59.94 55 5.31
97.06 3.96 76.36 74 1.96 102.96 3.96 58.88 55 4.25
97.10 4.00 74.40 74 0.00 103.00 4.00 54.63 55 0.00

Table X: Comparison of Excel and Determination Results,

New CU Test (n = 60).
Mean RSD Prob Prob Deviation Mean RSD Prob Excel Prob Deter. Deviation
(% LC) (%) Excel (%) Deter. (%) (%) (% LC) (%) (%) (%) (%)
97.00 4.60 73.71 74 0.00 102.90 4.60 59.04 59 0.00
97.04 4.64 72.10 74 1.61 102.94 4.64 55.38 59 3.66
97.05 4.65 71.70 70 2.06 102.95 4.65 54.46 50 4.63
97.06 4.66 71.29 70 1.65 102.96 4.66 53.53 50 3.70
97.10 4.70 69.64 70 0.00 103.00 4.70 49.83 50 0.00

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SAMPLING PLAN 1 AND 2 RECOMMENDATION FOR USE OF

To take a validation sample of the dosage units (e.g.,
tablets or capsules) for content uniformity testing, strat-
ified sampling plan 1 or 2 is followed. Sampling plan
1 will involve taking one unit from each of L locations
(e.g., 30 locations). Sampling plan 2 involves taking
two or more units from each of L locations through-
out the tablet compression or encapsulation cycle. In
multiple stage tests (including content uniformity), it
is unavoidable to employ sampling plan 2 since the
overall (stages 1 and 2) test number of dosage units
per location is more than 1 unit. Examples for sam-
pling plan 2, during compression or encapsulation
cycle, are illustrated in Table XI.
PROBABILITY CHARTS
For sampling plan 1 (one unit from each of L loca-
tions), the validation practitioners can simply use the
probability charts by using the sample mean and RSD.
For sampling plan 2 (two or more units from each of
L locations), a number of different charts are provided.
The data are required to be computed for within-loca-
tion standard deviation (SE) and between-location
standard deviation (SM) prior to determination of the
probability on the charts. Examples for computing
these statistics (SE and SM) and determining the prob-
ability using sampling plan 2 data are demonstrated
in Table XII and Figure 5, respectively. Table XII is pro-
vided with content uniformity data in cells B3:K5 and
related calculation formulae (10).

Table XI: Sampling Plans 1 and 2 with Examples for Plan 2.

Sampling/Testing Plans
Sampling plan: 1x20
Test plan: 1x20
Location # (of 20 Locations, L = 20)
1 2 3 4 5 6 ➔ 19 20
Sampling Plan 1 (One Unit from Each Location)
1 1 1 1 1 1➔1 1
1 1 1 1 1 1➔1 1

Take 1 unit from each of 20 locations. Test each unit in order.

Sampling Plan 2 (More than One Unit, e.g., 7 Units, from Each Location)

Sampling plan: 7x20 7 7 7 7 7 7➔7 7

Take 7 units from each of 20 locations throughout the operation cycle and keep each location sample in separate
container.
Stage 1 test plan: 3x20 3 3 3 3 3 3➔3 3
Test 3 units of each location in order, the test results for 3x20 units require to meet stage 1’s acceptance criteria. If
failed, proceed to stage 2.
Stage 2 test plan: 4x20 4 4 4 4 4 4➔4 4
Test 4 remaining units of each location in order, the overall test results for 7x20 units should meet stage 2’s
acceptance criteria.
Examples for Stratified Sampling Plan 2: Compression/Encapsulation Cycle *

Tests Sampling Plans (nxL) Testing Plans (nxL)

Stage1: 3 units x 20 locations
Content Uniformity 7 units x 20 locations
Stage2: 4 units x 20 locations
Stage1: 2 units x 20 locations
Dissolution 5 units x 20 locations
Stage2: 3 units x 20 locations
Stage1: 1 unit x 20 locations
Degradents 3 units x 20 locations
Stage2: 2 units x 20 locations

* Modified from Reference (9), n: sample size at each location, L: number of locations

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Table XII: Evaluation of Data from Sampling Plan 2 (N = nxL = 3x10).

Excel Formula Sheet

A B C D E F G H I J K
1 Stratified Sampling Location # (Sampling Plan 2: 3 Units x 10 Locations)
Unit #
2 1 2 3 4 5 6 7 8 9 10
3 1 95.01 93.91 99.37 97.97 94.93 93.83 101.31 98.74 97.87 106.44

4 2 100.93 99.11 103.93 105.8 98.52 105.85 96.48 97.53 103.71 99.18

5 3 102.27 98.96 99.83 97.64 100.27 98.68 97.46 95.83 98.23 96.14

6 SQD 29.85 17.52 12.61 42.67 14.82 73.14 13.04 4.27 21.42 56.01

7 Average (% LC) 99.19* RSD (%) 3.43 N (nxL) 30

8 Degree of freedom (between-location) (L-1) 9

9 Degree of freedom (within-location) {(n-1)L} 20 C7 =AVERAGE(B3:K5)

G7 =STDEV(B3:K5)/C7, K7 =3*10
10 Total square deviation 335.56
B6 = DEVSQ(B3:B5)
11 Square deviation (within-location) 285.35 C6,…,K6 – same as B6
F8 =10-1, F9 =(3-1)*10
12 Square deviation (between-location) 50.21 F10 =DEVSQ(B3:K5), F11 =SUM(B6:K6)
F12 =F10-F11, F13 =(F11/F9)^0.5
13 Standard deviation (within-location) (SE) 3.78*
F14 =(F12/F8)^0.5
14 Standard deviation (between-location) (SM) 2.36*

15 Note: SQD: Square Deviation -

16 Probability of Passing the USP CU Test Calculated** Determined

17 Probability (Current Tablet CU Test) 91.17% 90%

18 Probability (Current Capsule CU Test) 99.25% 99%

19 Probability (New CU Test) 91.31% 90%

20 *These data are used for determination of the probability in Figure 5 where rounded numbers are used

21 i.e., 99.19 ➔ 99.2 (C7), 3.78 ➔ 3.8 (F13) & 2.36 ➔ 2.4 (F14).

22 **Calculated (in Tables IV & V ) from the upper & lower bounds estimated using ANOVA (11)

23 SE = Square Root of Mean Square Error, SM = Standard Deviation of Location Means

Upon completing a trial using an Excel formula sheet CONCLUSION

(using worst cases of numerical values), the deviation
was found to be about 6% at maximum because of
poor processes, i.e., the mean deviated from the target
value with high variability (within-location and be-
tween-location), resulting in low probability results.
Table XIII provides an example of the worst cases and
probability results data.
The concept of probability charts will help validation
practitioners visualize the integrated views of the lower
probability bound distributions and understand the
effect of sample mean location and variability (e.g.,
RSD, SE, and SM) on the probability of passing the
USP content uniformity test. Acceptability of the prob-
ability charts is subject to the chart accuracy. The charts
with accuracy better than those provided in Appendix
2 of this article can be developed, but the consequence

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Table XIII: Comparison of Excel and Determination Results (n = 30).

Comparison of Excel and Determination Results

Current CU Test: Tablets New CU Test

Mean
SE SM Prob Exc
(% LC) Prob Det (%) Dev (%) Prob Exc (%) Prob Det (%) Dev (%)
(%)
96.54 3.65 2.65 61.44 57 4.44 48.79 43 5.79

97.54 3.75 2.75 72.00 68 4.00 62.70 57 5.70

98.54 3.85 2.85 79.72 77 2.72 74.26 70 4.26

101.55 3.75 2.75 84.07 81 3.07 79.80 75 4.80

102.55 3.65 2.65 76.73 73 3.73 69.38 64 5.38

103.55 3.55 2.55 66.54 62 4.54 56.10 50 6.10*

SE = Square Root of Mean Square Error, SM = Standard Deviation of Location Means, * Maximum

Figure 5: Determining Probability Using Sampling Plan 2 Data (n = 30).

JOURNAL OF VALIDATION TECHNOLOGY [SPRING 2008] 13

 P R A M O T E C H O L AY U D T H

are that a lot of charts will have to be generated, since
one chart may be broken down into two or three charts,
resulting in complication of their use. Justification of
the accuracy (i.e., deviation) on practical basis, as de-
scribed earlier, should be acceptable. Since the worst
case probability results (low results at 50 to 60% with
deviation of up to 5 or 6%) will occur only to inade-
quately controlled and/or developed processes. The
adequately developed processes with proper in-process
control will not fall into this case (i.e., the deviation
will be much less than 5%).
9. Pluta, P., “Keep in Step with Confidence; Keep in Step
through Benchmarking” Journal of Validation Technology,
Volume 12, No. 1, November 2005.
10. Cholayudth, P., “Application of Probability of Passing
Multiple Stage Tests in Benchmarking and Validation of
Processes” Journal of Validation Technology, Volume 13,
No. 4, August 2007.
11. Chow, S.C. and Liu, Statistical Design and Analysis in Phar-
maceutical Science: Validation, Process Controls, Practical
and Clinical Applications, 3rd ed. New York: Marcel Dekker,
Inc. JVT

REFERENCES ARTICLE ACRONYM LISTING

1. FDA Center for Drug Evaluation and Research (CDER), AV Acceptance Value
Draft Guidance for Industry: Powder Blends and Finished CQAs Critical Quality Attributes
Dosage Units—Stratified In-Process Dosage Unit Sampling FDA Food and Drug Administration
and Assessment, Rockville, MD , October 2003. ICH International Conference on Harmonization
2. Product Quality Research Institute (PQRI) Blend Unifor- LB Lower Bound
mity Working Group (BUWG), “The Use of Stratified Sam- LC Label Claim
pling of Blend and Dosage Units to Demonstrate Ade- MS Microsoft
quacy of Mix for Powder Blends,”Final Report on Blend OC Operating Characteristic
Uniformity Recommendations, December 20, 2002, PDA Parenteral Drug Association
www.pqri.org. PQRI Product Quality Research Institute
3. Parenteral Drug Association, “Blend Uniformity Analy- RSD Relative Standard Deviation
sis: Validation and In-Process Testing,” PDA Technical Re- SD Standard Deviation (for a Sample)
port No. 25,1997. SE Square Root of Mean Square Error
4. Torbeck, L. D., “In Defense of USP Singlet Testing,” Phar- Sigma Population Standard Deviation
maceutical Technology, Volume 29, Number 2, February SM Standard Deviation of Location Means
2005, www.pharmtech.com. UB Upper Bound
5. J. S. Bergum, “Constructing Acceptance Limits for Multi- USP United States Pharmacopeia
ple Stage Tests,” Drug Development and Industrial Phar-
macy, 16 (14), Marcel Dekker, Inc, 1990, pp. 2153-2166.
6. J. S. Bergum and H. Li, “Acceptance Limits for the New ACKNOWLEDGMENT
ICH USP 29 Content-Uniformity Test,” Pharmaceutical This paper is intended to support James Bergum’s meth-
Technology, October 2007, Vol. 31, No. 10, ods with regard to probability of passing the current
www.pharmtech.com. and new USP Content Uniformity tests. Although the
7. Cholayudth, P., “Use of the Bergum Method and MS Excel Microsoft Excel programs were developed from his SAS
to Determine the Probability of Passing the USP Content programs by the author (7, 8), a more practical ap-
Uniformity Test,” Pharmaceutical Technology, Volume 28, proach to use the distribution curves for lower proba-
Number 9, September 2004, www.pharmtech.com. bility bounds in place of the Excel programs is intro-
8. Cholayudth, P., “Using Bergum’s New Method and MS duced. Finally, the author is very grateful to the
Excel to Determine the Probability of Passing the New reviewers of this paper for their helpful comments es-
ICH USP 29 Content Uniformity Test” Journal of Valida- pecially regarding the OC curves.
tion Technology, Volume 14, No. 2, February 2008.

JOURNAL OF VALIDATION TECHNOLOGY [SPRING 2008] 79

PEER REVIEWED

APPENDIX 1 EXCEL FORMULAE

Table XIV: Tablet formulae: Current USP test.

Tablet formulae are as below:
D3 =MIN(D4,D5)

D4 =MAX((FDIST(10/((0.06^2)*(1+10*(B5/B7)^2)),(1+10*(B5/B7)^2)^2/(1+2*10*(B5/B7)^2),10-1))+
((NORMSDIST((115-B5)/B7)-NORMSDIST((85-B5)/B7))^10)-
1,(FDIST(30/((0.078^2)*(1+30*(B5/B7)^2)),(1+30*(B5/B7)^2)^2/(1+2*30*(B5/B7)^2),30-1))+((NORMSDIST((115-B5)/B7)-
NORMSDIST((85-B5)/B7))^30+COMBIN(30,1)*((NORMSDIST((115-B5)/B7)-NORMSDIST((85-B5)/B7))^29)*(((NORMS-
DIST((85-B5)/B7)-NORMSDIST((75-B5)/B7))+(NORMSDIST((125-B5)/B7)-NORMSDIST((115-B5)/B7)))^1))-1,0)

D5 =MAX((FDIST(10/((0.06^2)*(1+10*(B6/B7)^2)),(1+10*(B6/B7)^2)^2/(1+2*10*(B6/B7)^2),10-1))+((NORMSDIST((115-
B6)/B7)-NORMSDIST((85-B6)/B7))^10)-
1,(FDIST(30/((0.078^2)*(1+30*(B6/B7)^2)),(1+30*(B6/B7)^2)^2/(1+2*30*(B6/B7)^2),30-1))+((NORMSDIST((115-B6)/B7)-
NORMSDIST((85-B6)/B7))^30+COMBIN(30,1)*((NORMSDIST((115-B6)/B7)-NORMSDIST((85-B6)/B7))^29)*(((NORMSDI
ST((85-B6)/B7)-NORMSDIST((75-B6)/B7))+(NORMSDIST((125-B6)/B7)-NORMSDIST((115-B6)/B7)))^1))-1,0)

Table XV: Capsule formulae: Current USP test.

Capsule formulae are as below:
F3 =MIN(F4,F5), F4 =MAX(F7,F8,0), F5 =MAX(F10,F11,0)

F7 =(FDIST(10/((0.06^2)*(1+10*(B5/B7)^2)),(1+10*(B5/B7)^2)^2/(1+2*10*(B5/B7)^2),10-1))+((NORMSDIST((115-
B5)/B7)-NORMSDIST((85-B5)/B7))^10+COMBIN(10,1)*((NORMSDIST((115-B5)/B7)-NORMSDIST((85-
B5)/B7))^9)*(((NORMSDIST((B5-75)/B7)-NORMSDIST((B5-85)/B7))+(NORMSDIST((125-B5)/B7)-NORMSDIST((115-
B5)/B7)))^1))-1

F8 =(FDIST(30/((0.078^2)*(1+30*(B5/B7)^2)),(1+30*(B5/B7)^2)^2/(1+2*30*(B5/B7)^2),30-1))+((NORMSDIST((115-
B5)/B7)-NORMSDIST((85-B5)/B7))^30+COMBIN(30,1)*((NORMSDIST((115-B5)/B7)-NORMSDIST((85-
B5)/B7))^29)*(((NORMSDIST((85-B5)/B7)-NORMSDIST((75-B5)/B7))+(NORMSDIST((125-B5)/B7)-NORMSDIST((115-
B5)/B7)))^1)+COMBIN(30,2)*((NORMSDIST((115-B5)/B7)-NORMSDIST((85-B5)/B7))^28)*(((NORMSDIST((85-B5)/B7)-N
ORMSDIST((75-B5)/B7))+(NORMSDIST((125-B5)/B7)-NORMSDIST((115-B5)/B7)))^2)+COMBIN(30,3)*((NORMS-
DIST((115-B5)/B7)-NORMSDIST((85-B5)/B7))^27)*(((NORMSDIST((85-B5)/B7)-NORMSDIST((75-B5)/B7))+(NORMS-
DIST((125-B5)/B7)-NORMSDIST((115-B5)/B7)))^3))-1

F10 =(FDIST(10/((0.06^2)*(1+10*(B6/B7)^2)),(1+10*(B6/B7)^2)^2/(1+2*10*(B6/B7)^2),10-1))+((NORMSDIST((115-
B6)/B7)-NORMSDIST((85-B6)/B7))^10+COMBIN(10,1)*((NORMSDIST((115-B6)/B7)-NORMSDIST((85-
B6)/B7))^9)*(((NORMSDIST((B6-75)/B7)-NORMSDIST((B6-85)/B7))+(NORMSDIST((125-B6)/B7)-NORMSDIST((115-
B6)/B7)))^1))-1

F11 =(FDIST(30/((0.078^2)*(1+30*(B6/B7)^2)),(1+30*(B6/B7)^2)^2/(1+2*30*(B6/B7)^2),30-1))+((NORMSDIST((115-
B6)/B7)-NORMSDIST((85-B6)/B7))^30+COMBIN(30,1)*((NORMSDIST((115-B6)/B7)-NORMSDIST((85-
B6)/B7))^29)*(((NORMSDIST((85-B6)/B7)-NORMSDIST((75-B6)/B7))+(NORMSDIST((125-B6)/B7)-NORMSDIST((115-
B6)/B7)))^1)+COMBIN(30,2)*((NORMSDIST((115-B6)/B7)-NORMSDIST((85-B6)/B7))^28)*(((NORMSDIST((85-B6)/B7)-N
ORMSDIST((75-B6)/B7))+(NORMSDIST((125-B6)/B7)-NORMSDIST((115-B6)/B7)))^2)+COMBIN(30,3)*((NORMS-
DIST((115-B6)/B7)-NORMSDIST((85-B6)/B7))^27)*(((NORMSDIST((85-B6)/B7)-NORMSDIST((75-B6)/B7))+(NORMS-
DIST((125-B6)/B7)-NORMSDIST((115-B6)/B7)))^3))-1

APPENDIX 2 PROBABILITY CHARTS

Appendix 2 is available for download at http://www.ivthome.com/jvtspring. Probability charts provided in
Appendix 2 are presented in order of sampling plan types and overall sample sizes. The charts for 1 unit x 60
locations are also available although it is not practical to do the sampling. The author only wants the readers
to have the integrated views on this sampling plan 1.

80 JOURNAL OF VALIDATION TECHNOLOGY [SPRING 2008] ivthome.com

 INSTITUTE OF VALIDATION TECHNOLOGY

Journal of Validation Technology

MAY 2008 ISSUE

ARTICLE:
Evaluation of Validation Content Uniformity Test Results
Using Probability Distribution Charts
By: Pramote Cholayudth

APPENDIX 2: PROBABILITY CHARTS

Probability charts provided in the following pages are presented in order of product
types, sampling plan types and overall sample sizes. All the charts are constructed on
95% joint confidence level. The charts for 1 unit x 60 locations are also available
although it is not practical to do the sampling. The author only wants the readers to
have the integrated views on this sampling plan 1. In the new USP test, the
probability charts provided are applicable to the processes with target of not more
than 101.5% label claim (LC). For processes with target > 101.5% LC, please
contact cpramote2000@yahoo.com.

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 INSTITUTE OF VALIDATION TECHNOLOGY
TABLE OF CONTENTS (CURRENT USP TEST: TABLETS)

Sampling Plan 1 (1 x 30): Current USP Test (RSD: 2.1 – 4.8%) 4

Sampling Plan 1 (1 x 60): Current USP Test (RSD: 2.7 – 5.4%) 7

Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.0 – 4.7, SM: 0.3 – 0.7) 10

Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.9 – 4.6, SM: 0.8 – 1.2) 13

Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.9 – 4.6, SM: 1.3 – 1.7) 16

Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.8 – 4.5, SM: 1.8 – 2.2) 19

Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.7 – 4.4, SM: 2.3 – 2.6) 22

Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.6 – 4.3, SM: 2.7 – 2.9) 25

Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.6 – 4.3, SM: 3.0 – 3.2) 28

Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.4 – 4.1, SM: 3.3 – 3.5) 31

Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.0 – 3.7, SM: 3.6 – 3.8) 34

Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.6 – 5.3, SM: 0.3 – 0.7) 37

Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.6 – 5.3, SM: 0.8 – 1.2) 40

Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.5 – 5.2, SM: 1.3 – 1.7) 43

Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.5 – 5.2, SM: 1.8 – 2.2) 46

Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.5 – 5.2, SM: 2.3 – 2.6) 49

Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.5 – 5.2, SM: 2.7 – 2.9) 52

Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.4 – 5.1, SM: 3.0 – 3.2) 55

Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.4 – 5.1, SM: 3.3 – 3.5) 58

Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.4 – 5.1, SM: 3.6 – 3.8) 61

TABLE OF CONTENTS (CURRENT USP TEST: CAPSULES)

 Sampling Plan 1 (1 x 30): Current USP Test (RSD: 2.5 – 5.2%) 5

 Sampling Plan 1 (1 x 60): Current USP Test (RSD: 3.0 – 5.7%) 8
 Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.3 – 5.0, SM: 0.3 – 0.7) 11
 Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.3 – 5.0, SM: 0.8 – 1.2) 14
 Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.3 – 5.0, SM: 1.3 – 1.7) 17
 Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.2 – 4.9, SM: 1.8 – 2.2) 20
 Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.2 – 4.9, SM: 2.3 – 2.6) 23
 Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.1 – 4.8, SM: 2.7 – 2.9) 26
 Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.1 – 4.8, SM: 3.0 – 3.2) 29
 Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.1 – 4.8, SM: 3.3 – 3.5) 32
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 INSTITUTE OF VALIDATION TECHNOLOGY
 Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.9 – 4.6, SM: 3.6 – 3.8) 35
 Sampling Plan 2 (3 x 20): Current USP Test (SE: 3.1 – 5.8, SM: 0.3 – 0.7) 38
 Sampling Plan 2 (3 x 20): Current USP Test (SE: 3.0 – 5.7, SM: 0.8 – 1.2) 41
 Sampling Plan 2 (3 x 20): Current USP Test (SE: 3.0 – 5.7, SM: 1.3 – 1.7) 44
 Sampling Plan 2 (3 x 20): Current USP Test (SE: 3.0 – 5.7, SM: 1.8 – 2.2) 47
 Sampling Plan 2 (3 x 20): Current USP Test (SE: 3.0 – 5.7, SM: 2.3 – 2.6) 50
 Sampling Plan 2 (3 x 20): Current USP Test (SE: 3.0 – 5.7, SM: 2.7 – 2.9) 53
 Sampling Plan 2 (3 x 20): Current USP Test (SE: 3.0 – 5.7, SM: 3.0 – 3.2) 56
 Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.9 – 5.6, SM: 3.3 – 3.5) 59
 Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.9 – 5.6, SM: 3.6 – 3.8) 62

TABLE OF CONTENTS (NEW USP TEST: TABLETS/CAPSULES)

• Sampling Plan 1 (1 x 30): New USP Test (RSD: 2.0 – 4.7%) 6

• Sampling Plan 1 (1 x 60): New USP Test (RSD: 2.7 – 5.4%) 9
• Sampling Plan 2 (3 x 10): New USP Test (SE: 2.0 – 4.7, SM: 0.3 – 0.7) 12
• Sampling Plan 2 (3 x 10): New USP Test (SE: 1.9 – 4.6, SM: 0.8 – 1.2) 15
• Sampling Plan 2 (3 x 10): New USP Test (SE: 1.9 – 4.6, SM: 1.3 – 1.7) 18
• Sampling Plan 2 (3 x 10): New USP Test (SE: 1.7 – 4.4, SM: 1.8 – 2.2) 21
• Sampling Plan 2 (3 x 10): New USP Test (SE: 1.6 – 4.3, SM: 2.3 – 2.6) 24
• Sampling Plan 2 (3 x 10): New USP Test (SE: 1.4 – 4.1, SM: 2.7 – 2.9) 27
• Sampling Plan 2 (3 x 10): New USP Test (SE: 1.4 – 4.1, SM: 3.0 – 3.2) 30
• Sampling Plan 2 (3 x 10): New USP Test (SE: 1.0 – 3.7, SM: 3.3 – 3.5) 33
• Sampling Plan 2 (3 x 10): New USP Test (SE: 0.7 – 3.4, SM: 3.6 – 3.8) 36
• Sampling Plan 2 (3 x 20): New USP Test (SE: 2.7 – 5.4, SM: 0.3 – 0.7) 39
• Sampling Plan 2 (3 x 20): New USP Test (SE: 2.7 – 5.4, SM: 0.8 – 1.2) 42
• Sampling Plan 2 (3 x 20): New USP Test (SE: 2.6 – 5.3, SM: 1.3 – 1.7) 45
• Sampling Plan 2 (3 x 20): New USP Test (SE: 2.5 – 5.2, SM: 1.8 – 2.2) 48
• Sampling Plan 2 (3 x 20): New USP Test (SE: 2.5 – 5.2, SM: 2.3 – 2.6) 51
• Sampling Plan 2 (3 x 20): New USP Test (SE: 2.4 – 5.1, SM: 2.7 – 2.9) 54
• Sampling Plan 2 (3 x 20): New USP Test (SE: 2.4 – 5.1, SM: 3.0 – 3.2) 57
• Sampling Plan 2 (3 x 20): New USP Test (SE: 2.3 – 5.0, SM: 3.3 – 3.5) 60
• Sampling Plan 2 (3 x 20): New USP Test (SE: 2.3 – 5.0, SM: 3.6 – 3.8) 63

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 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 1 (1 x 30): Current USP Test (RSD: 2.1 – 4.8%)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 1x30 = 30, RSD = 2.1-4.7%)

100%

95%

2.1%
90%
2.3%
2.5%
85%
2.7%
2.9%
80%
Probability (%)

3.1%
3.3%
75% 3.5%
3.7%
70% 3.9%
4.1%
65% 4.3%
4.5%
60% 4.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 1x30 = 30, RSD = 2.2-4.8%)

100%

95%

2.2%
90%
2.4%
2.6%
85%
2.8%
3%
80%
Probability (%)

3.2%
3.4%
75% 3.6%
3.8%
70% 4%
4.2%
65% 4.4%
4.6%
60% 4.8%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 1 (1 x 30): Current USP Test (RSD: 2.5 – 5.2%)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 1x30 = 30, RSD = 2.5-5.1%)

100%

95%

2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)

3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 1x30 = 30, RSD = 2.6-5.2%)

100%

95%

2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)

3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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Sampling Plan 1 (1 x 30): New USP Test (RSD: 2.0 – 4.7%)

Probability of Passing New USP 29 Content Uniformity Test (N = 1x30 = 30, RSD = 2.0-4.6%)

100%

95%

2%
90%
2.2%
2.4%
85%
2.6%
2.8%
80%
Probability (%)

3%
3.2%
75% 3.4%
3.6%
70% 3.8%
4%
65% 4.2%
4.4%
60% 4.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 1x30 = 30, RSD = 2.1-4.7%)

100%

95%

2.1%
90%
2.3%
2.5%
85%
2.7%
2.9%
80%
Probability (%)

3.1%
3.3%
75% 3.5%
3.7%
70% 3.9%
4.1%
65% 4.3%
4.5%
60% 4.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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6/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 1 (1 x 60): Current USP Test (RSD: 2.7 – 5.4%)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 1x60 = 60, RSD = 2.7-5.3%)

100%

95%

2.7%
90%
2.9%
3.1%
85%
3.3%
3.5%
80%
Probability (%)

3.7%
3.9%
75% 4.1%
4.3%
70% 4.5%
4.7%
65% 4.9%
5.1%
60% 5.3%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 1x60 = 60, RSD = 2.8-5.4%)

100%

95%

2.8%
90%
3%
3.2%
85%
3.4%
3.6%
80%
Probability (%)

3.8%
4%
75% 4.2%
4.4%
70% 4.6%
4.8%
65% 5%
5.2%
60% 5.4%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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7/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 1 (1 x 60): Current USP Test (RSD: 3.0 – 5.7%)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 1x60 = 60, RSD = 3.0-5.6%)

100%

95%

3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)

4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 1x60 = 60, RSD = 3.1-5.7%)

100%

95%

3.1%
90%
3.3%
3.5%
85%
3.7%
3.9%
80%
Probability (%)

4.1%
4.3%
75% 4.5%
4.7%
70% 4.9%
5.1%
65% 5.3%
5.5%
60% 5.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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8/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 1 (1 x 60): New USP Test (RSD: 2.7 – 5.4%)

Probability of Passing New USP 29 Content Uniformity Test (N = 1x60 = 60, RSD = 2.7-5.3%)

100%

95%

2.7%
90%
2.9%
3.1%
85%
3.3%
3.5%
80%
Probability (%)

3.7%
3.9%
75% 4.1%
4.3%
70% 4.5%
4.7%
65% 4.9%
5.1%
60% 5.3%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 1x60 = 60, RSD = 2.8-5.4%)

100%

95%

2.8%
90%
3%
3.2%
85%
3.4%
3.6%
80%
Probability (%)

3.8%
4%
75% 4.2%
4.4%
70% 4.6%
4.8%
65% 5%
5.2%
60% 5.4%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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9/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.0 – 4.7, SM: 0.3 – 0.7)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 2.0-4.6, SM = 0.5)

100%

95%

2%
90%
2.2%
2.4%
85%
2.6%
2.8%
80%
Probability (%)

3%
3.2%
75% 3.4%
3.6%
70% 3.8%
4%
65% 4.2%
4.4%
60% 4.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 2.1-4.7, SM = 0.5)

100%

95%

2.1%
90%
2.3%
2.5%
85%
2.7%
2.9%
80%
Probability (%)

3.1%
3.3%
75% 3.5%
3.7%
70% 3.9%
4.1%
65% 4.3%
4.5%
60% 4.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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10/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.3 – 5.0, SM: 0.3 – 0.7)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.3-4.9, SM = 0.5)

100%

95%

2.3%
90%
2.5%
2.7%
85%
2.9%
3.1%
80%
Probability (%)

3.3%
3.5%
75% 3.7%
3.9%
70% 4.1%
4.3%
65% 4.5%
4.7%
60% 4.9%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.4-5.0, SM = 0.5)

100%

95%

2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)

3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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11/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): New USP Test (SE: 2.0 – 4.7, SM: 0.3 – 0.7)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 2.0-4.6, SM = 0.5)

100%

95%

2%
90%
2.2%
2.4%
85%
2.6%
2.8%
80%
Probability (%)

3%
3.2%
75% 3.4%
3.6%
70% 3.8%
4%
65% 4.2%
4.4%
60% 4.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 2.1-4.7, SM = 0.5)

100%

95%

2.1%
90%
2.3%
2.5%
85%
2.7%
2.9%
80%
Probability (%)

3.1%
3.3%
75% 3.5%
3.7%
70% 3.9%
4.1%
65% 4.3%
4.5%
60% 4.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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12/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.9 – 4.6, SM: 0.8 – 1.2)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.9-4.5, SM = 1.0)

100%

95%

1.9%
90%
2.1%
2.3%
85%
2.5%
2.7%
80%
Probability (%)

2.9%
3.1%
75% 3.3%
3.5%
70% 3.7%
3.9%
65% 4.1%
4.3%
60% 4.5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 2.0-4.6, SM = 1.0)

100%

95%

2%
90%
2.2%
2.4%
85%
2.6%
2.8%
80%
Probability (%)

3%
3.2%
75% 3.4%
3.6%
70% 3.8%
4%
65% 4.2%
4.4%
60% 4.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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13/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.3 – 5.0, SM: 0.8 – 1.2)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.3-4.9, SM = 1.0)

100%

95%

2.3%
90%
2.5%
2.7%
85%
2.9%
3.1%
80%
Probability (%)

3.3%
3.5%
75% 3.7%
3.9%
70% 4.1%
4.3%
65% 4.5%
4.7%
60% 4.9%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.4-5.0, SM = 1.0)

100%

95%

2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)

3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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14/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): New USP Test (SE: 1.9 – 4.6, SM: 0.8 – 1.2)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.9-4.5, SM = 1.0)

100%

95%

1.9%
90%
2.1%
2.3%
85%
2.5%
2.7%
80%
Probability (%)

2.9%
3.1%
75% 3.3%
3.5%
70% 3.7%
3.9%
65% 4.1%
4.3%
60% 4.5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 2.0-4.6, SM = 1.0)

100%

95%

2%
90%
2.2%
2.4%
85%
2.6%
2.8%
80%
Probability (%)

3%
3.2%
75% 3.4%
3.6%
70% 3.8%
4%
65% 4.2%
4.4%
60% 4.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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15/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.9 – 4.6, SM: 1.3 – 1.7)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.9-4.5, SM = 1.5)

100%

95%

1.9%
90%
2.1%
2.3%
85%
2.5%
2.7%
80%
Probability (%)

2.9%
3.1%
75% 3.3%
3.5%
70% 3.7%
3.9%
65% 4.1%
4.3%
60% 4.5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 2.0-4.6, SM = 1.5)

100%

95%

2%
90%
2.2%
2.4%
85%
2.6%
2.8%
80%
Probability (%)

3%
3.2%
75% 3.4%
3.6%
70% 3.8%
4%
65% 4.2%
4.4%
60% 4.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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16/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.3 – 5.0, SM: 1.3 – 1.7)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.3-4.9, SM = 1.5)

100%

95%

2.3%
90%
2.5%
2.7%
85%
2.9%
3.1%
80%
Probability (%)

3.3%
3.5%
75% 3.7%
3.9%
70% 4.1%
4.3%
65% 4.5%
4.7%
60% 4.9%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.4-5.0, SM = 1.5)

100%

95%

2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)

3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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17/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): New USP Test (SE: 1.9 – 4.6, SM: 1.3 – 1.7)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.9-4.5, SM = 1.5)

100%

95%

1.9%
90%
2.1%
2.3%
85%
2.5%
2.7%
80%
Probability (%)

2.9%
3.1%
75% 3.3%
3.5%
70% 3.7%
3.9%
65% 4.1%
4.3%
60% 4.5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 2.0-4.6, SM = 1.5)

100%

95%

2%
90%
2.2%
2.4%
85%
2.6%
2.8%
80%
Probability (%)

3%
3.2%
75% 3.4%
3.6%
70% 3.8%
4%
65% 4.2%
4.4%
60% 4.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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18/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.8 – 4.5, SM: 1.8 – 2.2)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.8-4.4, SM = 2.0)

100%

95%

1.8%
90%
2%
2.2%
85%
2.4%
2.6%
80%
Probability (%)

2.8%
3%
75% 3.2%
3.4%
70% 3.6%
3.8%
65% 4%
4.2%
60% 4.4%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.9-4.5, SM = 2.0)

100%

95%

1.9%
90%
2.1%
2.3%
85%
2.5%
2.7%
80%
Probability (%)

2.9%
3.1%
75% 3.3%
3.5%
70% 3.7%
3.9%
65% 4.1%
4.3%
60% 4.5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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19/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.2 – 4.9, SM: 1.8 – 2.2)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.2-4.8, SM = 2.0)

100%

95%

2.2%
90%
2.4%
2.6%
85%
2.8%
3%
80%
Probability (%)

3.2%
3.4%
75% 3.6%
3.8%
70% 4%
4.2%
65% 4.4%
4.6%
60% 4.8%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.3-4.9, SM = 2.0)

100%

95%

2.3%
90%
2.5%
2.7%
85%
2.9%
3.1%
80%
Probability (%)

3.3%
3.5%
75% 3.7%
3.9%
70% 4.1%
4.3%
65% 4.5%
4.7%
60% 4.9%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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20/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): New USP Test (SE: 1.7 – 4.4, SM: 1.8 – 2.2)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.7-4.3, SM = 2.0)

100%

95%

1.7%
90%
1.9%
2.1%
85%
2.3%
2.5%
80%
Probability (%)

2.7%
2.9%
75% 3.1%
3.3%
70% 3.5%
3.7%
65% 3.9%
4.1%
60% 4.3%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.8-4.4, SM = 2.0)

100%

95%

1.8%
90%
2%
2.2%
85%
2.4%
2.6%
80%
Probability (%)

2.8%
3%
75% 3.2%
3.4%
70% 3.6%
3.8%
65% 4%
4.2%
60% 4.4%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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21/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.7 – 4.4, SM: 2.3 – 2.6)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.7-4.3, SM = 2.5)

100%

95%

1.7%
90%
1.9%
2.1%
85%
2.3%
2.5%
80%
Probability (%)

2.7%
2.9%
75% 3.1%
3.3%
70% 3.5%
3.7%
65% 3.9%
4.1%
60% 4.3%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.8-4.4, SM = 2.5)

100%

95%

1.8%
90%
2%
2.2%
85%
2.4%
2.6%
80%
Probability (%)

2.8%
3%
75% 3.2%
3.4%
70% 3.6%
3.8%
65% 4%
4.2%
60% 4.4%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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22/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.2 – 4.9, SM: 2.3 – 2.6)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.2-4.8, SM = 2.5)

100%

95%

2.2%
90%
2.4%
2.6%
85%
2.8%
3%
80%
Probability (%)

3.2%
3.4%
75% 3.6%
3.8%
70% 4%
4.2%
65% 4.4%
4.6%
60% 4.8%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.3-4.9, SM = 2.5)

100%

95%

2.3%
90%
2.5%
2.7%
85%
2.9%
3.1%
80%
Probability (%)

3.3%
3.5%
75% 3.7%
3.9%
70% 4.1%
4.3%
65% 4.5%
4.7%
60% 4.9%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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23/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): New USP Test (SE: 1.6 – 4.3, SM: 2.3 – 2.6)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.6-4.2, SM = 2.5)

100%

95%

1.6%
90%
1.8%
2%
85%
2.2%
2.4%
80%
Probability (%)

2.6%
2.8%
75% 3%
3.2%
70% 3.4%
3.6%
65% 3.8%
4%
60% 4.2%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.7-4.3, SM = 2.5)

100%

95%

1.7%
90%
1.9%
2.1%
85%
2.3%
2.5%
80%
Probability (%)

2.7%
2.9%
75% 3.1%
3.3%
70% 3.5%
3.7%
65% 3.9%
4.1%
60% 4.3%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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24/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.6 – 4.3, SM: 2.7 – 2.9)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.6-4.2, SM = 2.8)

100%

95%

1.6%
90%
1.8%
2%
85%
2.2%
2.4%
80%
Probability (%)

2.6%
2.8%
75% 3%
3.2%
70% 3.4%
3.6%
65% 3.8%
4%
60% 4.2%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.7-4.3, SM = 2.8)

100%

95%

1.7%
90%
1.9%
2.1%
85%
2.3%
2.5%
80%
Probability (%)

2.7%
2.9%
75% 3.1%
3.3%
70% 3.5%
3.7%
65% 3.9%
4.1%
60% 4.3%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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25/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.1 – 4.8, SM: 2.7 – 2.9)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.1-4.7, SM = 2.8)

100%

95%

2.1%
90%
2.3%
2.5%
85%
2.7%
2.9%
80%
Probability (%)

3.1%
3.3%
75% 3.5%
3.7%
70% 3.9%
4.1%
65% 4.3%
4.5%
60% 4.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.2-4.8, SM = 2.8)

100%

95%

2.2%
90%
2.4%
2.6%
85%
2.8%
3%
80%
Probability (%)

3.2%
3.4%
75% 3.6%
3.8%
70% 4%
4.2%
65% 4.4%
4.6%
60% 4.8%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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26/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): New USP Test (SE: 1.4 – 4.1, SM: 2.7 – 2.9)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.4-4.0, SM = 2.8)

100%

95%

1.4%
90%
1.6%
1.8%
85%
2%
2.2%
80%
Probability (%)

2.4%
2.6%
75% 2.8%
3%
70% 3.2%
3.4%
65% 3.6%
3.8%
60% 4%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.5-4.1, SM = 2.8)

100%

95%

1.5%
90%
1.7%
1.9%
85%
2.1%
2.3%
80%
Probability (%)

2.5%
2.7%
75% 2.9%
3.1%
70% 3.3%
3.5%
65% 3.7%
3.9%
60% 4.1%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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27/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.6 – 4.3, SM: 3.0 – 3.2)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.6-4.2, SM = 3.1)

100%

95%

1.6%
90%
1.8%
2%
85%
2.2%
2.4%
80%
Probability (%)

2.6%
2.8%
75% 3%
3.2%
70% 3.4%
3.6%
65% 3.8%
4%
60% 4.2%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.7-4.3, SM = 3.1)

100%

95%

1.7%
90%
1.9%
2.1%
85%
2.3%
2.5%
80%
Probability (%)

2.7%
2.9%
75% 3.1%
3.3%
70% 3.5%
3.7%
65% 3.9%
4.1%
60% 4.3%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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28/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.1 – 4.8, SM: 3.0 – 3.2)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.1-4.7, SM = 3.1)

100%

95%

2.1%
90%
2.3%
2.5%
85%
2.7%
2.9%
80%
Probability (%)

3.1%
3.3%
75% 3.5%
3.7%
70% 3.9%
4.1%
65% 4.3%
4.5%
60% 4.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.2-4.8, SM = 3.1)

100%

95%

2.2%
90%
2.4%
2.6%
85%
2.8%
3%
80%
Probability (%)

3.2%
3.4%
75% 3.6%
3.8%
70% 4%
4.2%
65% 4.4%
4.6%
60% 4.8%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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29/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): New USP Test (SE: 1.4 – 4.1, SM: 3.0 – 3.2)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.4-4.0, SM = 3.1)

100%

95%

1.4%
90%
1.6%
1.8%
85%
2%
2.2%
80%
Probability (%)

2.4%
2.6%
75% 2.8%
3%
70% 3.2%
3.4%
65% 3.6%
3.8%
60% 4%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.5-4.1, SM = 3.1)

100%

95%

1.5%
90%
1.7%
1.9%
85%
2.1%
2.3%
80%
Probability (%)

2.5%
2.7%
75% 2.9%
3.1%
70% 3.3%
3.5%
65% 3.7%
3.9%
60% 4.1%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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30/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.4 – 4.1, SM: 3.3 – 3.5)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.4-4.0, SM = 3.4)

100%

95%

1.4%
90%
1.6%
1.8%
85%
2%
2.2%
80%
Probability (%)

2.4%
2.6%
75% 2.8%
3%
70% 3.2%
3.4%
65% 3.6%
3.8%
60% 4%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.5-4.1, SM = 3.4)

100%

95%

1.5%
90%
1.7%
1.9%
85%
2.1%
2.3%
80%
Probability (%)

2.5%
2.7%
75% 2.9%
3.1%
70% 3.3%
3.5%
65% 3.7%
3.9%
60% 4.1%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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31/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 2.1 – 4.8, SM: 3.3 – 3.5)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.1-4.7, SM = 3.4)

100%

95%

2.1%
90%
2.3%
2.5%
85%
2.7%
2.9%
80%
Probability (%)

3.1%
3.3%
75% 3.5%
3.7%
70% 3.9%
4.1%
65% 4.3%
4.5%
60% 4.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.2-4.8, SM = 3.4)

100%

95%

2.2%
90%
2.4%
2.6%
85%
2.8%
3%
80%
Probability (%)

3.2%
3.4%
75% 3.6%
3.8%
70% 4%
4.2%
65% 4.4%
4.6%
60% 4.8%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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32/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): New USP Test (SE: 1.0 – 3.7, SM: 3.3 – 3.5)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.0-3.6, SM = 3.4)

100%

95%

1%
90%
1.2%
1.4%
85%
1.6%
1.8%
80%
Probability (%)

2%
2.2%
75% 2.4%
2.6%
70% 2.8%
3%
65% 3.2%
3.4%
60% 3.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 1.1-3.7, SM = 3.4)

100%

95%

1.1%
90%
1.3%
1.5%
85%
1.7%
1.9%
80%
Probability (%)

2.1%
2.3%
75% 2.5%
2.7%
70% 2.9%
3.1%
65% 3.3%
3.5%
60% 3.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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33/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.0 – 3.7, SM: 3.6 – 3.8)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.0-3.6, SM = 3.7)

100%

95%

1%
90%
1.2%
1.4%
85%
1.6%
1.8%
80%
Probability (%)

2%
2.2%
75% 2.4%
2.6%
70% 2.8%
3%
65% 3.2%
3.4%
60% 3.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x10 = 30, SE = 1.1-3.7, SM = 3.7)

100%

95%

1.1%
90%
1.3%
1.5%
85%
1.7%
1.9%
80%
Probability (%)

2.1%
2.3%
75% 2.5%
2.7%
70% 2.9%
3.1%
65% 3.3%
3.5%
60% 3.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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34/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): Current USP Test (SE: 1.9 – 4.6, SM: 3.6 – 3.8)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 1.9-4.5, SM = 3.7)

100%

95%

1.9%
90%
2.1%
2.3%
85%
2.5%
2.7%
80%
Probability (%)

2.9%
3.1%
75% 3.3%
3.5%
70% 3.7%
3.9%
65% 4.1%
4.3%
60% 4.5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x10 = 30, SE = 2.0-4.6, SM = 3.7)

100%

95%

2%
90%
2.2%
2.4%
85%
2.6%
2.8%
80%
Probability (%)

3%
3.2%
75% 3.4%
3.6%
70% 3.8%
4%
65% 4.2%
4.4%
60% 4.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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35/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 10): New USP Test (SE: 0.7 – 3.4, SM: 3.6 – 3.8)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 0.7-3.3, SM = 3.7)

100%

95%

0.7%
90%
0.9%
1.1%
85%
1.3%
1.5%
80%
Probability (%)

1.7%
1.9%
75% 2.1%
2.3%
70% 2.5%
2.7%
65% 2.9%
3.1%
60% 3.3%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x10 = 30, SE = 0.8-3.4, SM = 3.7)

100%

95%

0.8%
90%
1%
1.2%
85%
1.4%
1.6%
80%
Probability (%)

1.8%
2%
75% 2.2%
2.4%
70% 2.6%
2.8%
65% 3%
3.2%
60% 3.4%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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36/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.6 – 5.3, SM: 0.3 – 0.7)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 0.5)

100%

95%

2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)

3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.7-5.3, SM = 0.5)

100%

95%

2.7%
90%
2.9%
3.1%
85%
3.3%
3.5%
80%
Probability (%)

3.7%
3.9%
75% 4.1%
4.3%
70% 4.5%
4.7%
65% 4.9%
5.1%
60% 5.3%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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37/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 3.1 – 5.8, SM: 0.3 – 0.7)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.1-5.7, SM = 0.5)

100%

95%

3.1%
90%
3.3%
3.5%
85%
3.7%
3.9%
80%
Probability (%)

4.1%
4.3%
75% 4.5%
4.7%
70% 4.9%
5.1%
65% 5.3%
5.5%
60% 5.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.2-5.8, SM = 0.5)

100%

95%

3.2%
90%
3.4%
3.6%
85%
3.8%
4%
80%
Probability (%)

4.2%
4.4%
75% 4.6%
4.8%
70% 5%
5.2%
65% 5.4%
5.6%
60% 5.8%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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38/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): New USP Test (SE: 2.7 – 5.4, SM: 0.3 – 0.7)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.7-5.3, SM = 0.5)

100%

95%

2.7%
90%
2.9%
3.1%
85%
3.3%
3.5%
80%
Probability (%)

3.7%
3.9%
75% 4.1%
4.3%
70% 4.5%
4.7%
65% 4.9%
5.1%
60% 5.3%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.8-5.4, SM = 0.5)

100%

95%

2.8%
90%
3%
3.2%
85%
3.4%
3.6%
80%
Probability (%)

3.8%
4%
75% 4.2%
4.4%
70% 4.6%
4.8%
65% 5%
5.2%
60% 5.4%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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39/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.6 – 5.3, SM: 0.8 – 1.2)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 1.0)

100%

95%

2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)

3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.7-5.3, SM = 1.0)

100%

95%

2.7%
90%
2.9%
3.1%
85%
3.3%
3.5%
80%
Probability (%)

3.7%
3.9%
75% 4.1%
4.3%
70% 4.5%
4.7%
65% 4.9%
5.1%
60% 5.3%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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40/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 3.0 – 5.7, SM: 0.8 – 1.2)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.0-5.6, SM = 1.0)

100%

95%

3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)

4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.1-5.7, SM = 1.0)

100%

95%

3.1%
90%
3.3%
3.5%
85%
3.7%
3.9%
80%
Probability (%)

4.1%
4.3%
75% 4.5%
4.7%
70% 4.9%
5.1%
65% 5.3%
5.5%
60% 5.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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41/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): New USP Test (SE: 2.7 – 5.4, SM: 0.8 – 1.2)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.7-5.3, SM = 1.0)

100%

95%

2.7%
90%
2.9%
3.1%
85%
3.3%
3.5%
80%
Probability (%)

3.7%
3.9%
75% 4.1%
4.3%
70% 4.5%
4.7%
65% 4.9%
5.1%
60% 5.3%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.8-5.4, SM = 1.0)

100%

95%

2.8%
90%
3%
3.2%
85%
3.4%
3.6%
80%
Probability (%)

3.8%
4%
75% 4.2%
4.4%
70% 4.6%
4.8%
65% 5%
5.2%
60% 5.4%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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42/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.5 – 5.2, SM: 1.3 – 1.7)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 1.5)

100%

95%

2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)

3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 1.5)

100%

95%

2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)

3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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43/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 3.0 – 5.7, SM: 1.3 – 1.7)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.0-5.6, SM = 1.5)

100%

95%

3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)

4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.1-5.7, SM = 1.5)

100%

95%

3.1%
90%
3.3%
3.5%
85%
3.7%
3.9%
80%
Probability (%)

4.1%
4.3%
75% 4.5%
4.7%
70% 4.9%
5.1%
65% 5.3%
5.5%
60% 5.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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44/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): New USP Test (SE: 2.6 – 5.3, SM: 1.3 – 1.7)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 1.5)

100%

95%

2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)

3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.7-5.3, SM = 1.5)

100%

95%

2.7%
90%
2.9%
3.1%
85%
3.3%
3.5%
80%
Probability (%)

3.7%
3.9%
75% 4.1%
4.3%
70% 4.5%
4.7%
65% 4.9%
5.1%
60% 5.3%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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45/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.5 – 5.2, SM: 1.8 – 2.2)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 2.0)

100%

95%

2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)

3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 2.0)

100%

95%

2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)

3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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46/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 3.0 – 5.7, SM: 1.8 – 2.2)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.0-5.6, SM = 2.0)

100%

95%

3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)

4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.1-5.7, SM = 2.0)

100%

95%

3.1%
90%
3.3%
3.5%
85%
3.7%
3.9%
80%
Probability (%)

4.1%
4.3%
75% 4.5%
4.7%
70% 4.9%
5.1%
65% 5.3%
5.5%
60% 5.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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47/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): New USP Test (SE: 2.5 – 5.2, SM: 1.8 – 2.2)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 2.0)

100%

95%

2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)

3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 2.0)

100%

95%

2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)

3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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48/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.5 – 5.2, SM: 2.3 – 2.6)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 2.5)

100%

95%

2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)

3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC): n = 30

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 2.5)

100%

95%

2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)

3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC): n = 30

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49/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 3.0 – 5.7, SM: 2.3 – 2.6)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.0-5.6, SM = 2.5)

100%

95%

3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)

4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC): n = 30

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.1-5.7, SM = 2.5)

100%

95%

3.1%
90%
3.3%
3.5%
85%
3.7%
3.9%
80%
Probability (%)

4.1%
4.3%
75% 4.5%
4.7%
70% 4.9%
5.1%
65% 5.3%
5.5%
60% 5.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC): n = 30

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50/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): New USP Test (SE: 2.5 – 5.2, SM: 2.3 – 2.6)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 2.5)

100%

95%

2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)

3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC): n = 30

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 2.5)

100%

95%

2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)

3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC): n = 30

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51/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.5 – 5.2, SM: 2.7 – 2.9)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 2.8)

100%

95%

2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)

3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.6-5.2, SM = 2.8)

100%

95%

2.6%
90%
2.8%
3%
85%
3.2%
3.4%
80%
Probability (%)

3.6%
3.8%
75% 4%
4.2%
70% 4.4%
4.6%
65% 4.8%
5%
60% 5.2%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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52/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 3.0 – 5.7, SM: 2.7 – 2.9)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.0-5.6, SM = 2.8)

100%

95%

3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)

4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.1-5.7, SM = 2.8)

100%

95%

3.1%
90%
3.3%
3.5%
85%
3.7%
3.9%
80%
Probability (%)

4.1%
4.3%
75% 4.5%
4.7%
70% 4.9%
5.1%
65% 5.3%
5.5%
60% 5.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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53/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): New USP Test (SE: 2.4 – 5.1, SM: 2.7 – 2.9)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.4-5.0, SM = 2.8)

100%

95%

2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)

3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 2.8)

100%

95%

2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)

3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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54/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.4 – 5.1, SM: 3.0 – 3.2)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.4-5.0, SM = 3.1)

100%

95%

2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)

3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 3.1)

100%

95%

2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)

3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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55/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 3.0 – 5.7, SM: 3.0 – 3.2)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.0-5.6, SM = 3.1)

100%

95%

3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)

4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.1-5.7, SM = 3.1)

100%

95%

3.1%
90%
3.3%
3.5%
85%
3.7%
3.9%
80%
Probability (%)

4.1%
4.3%
75% 4.5%
4.7%
70% 4.9%
5.1%
65% 5.3%
5.5%
60% 5.7%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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56/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): New USP Test (SE: 2.4 – 5.1, SM: 3.0 – 3.2)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.4-5.0, SM = 3.1)

100%

95%

2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)

3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 3.1)

100%

95%

2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)

3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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57/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.4 – 5.1, SM: 3.3 – 3.5)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.4-5.0, SM = 3.4)

100%

95%

2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)

3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 3.4)

100%

95%

2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)

3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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58/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.9 – 5.6, SM: 3.3 – 3.5)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 2.9-5.5, SM = 3.4)

100%

95%

2.9%
90%
3.1%
3.3%
85%
3.5%
3.7%
80%
Probability (%)

3.9%
4.1%
75% 4.3%
4.5%
70% 4.7%
4.9%
65% 5.1%
5.3%
60% 5.5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.0-5.6, SM = 3.4)

100%

95%

3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)

4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): New USP Test (SE: 2.3 – 5.0, SM: 3.3 – 3.5)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.3-4.9, SM = 3.4)

100%

95%

2.3%
90%
2.5%
2.7%
85%
2.9%
3.1%
80%
Probability (%)

3.3%
3.5%
75% 3.7%
3.9%
70% 4.1%
4.3%
65% 4.5%
4.7%
60% 4.9%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.4-5.0, SM = 3.4)

100%

95%

2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)

3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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60/63
 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.4 – 5.1, SM: 3.6 – 3.8)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.4-5.0, SM = 3.7)

100%

95%

2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)

3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Tablet Content Uniformity Test (N = 3x20 = 60, SE = 2.5-5.1, SM = 3.7)

100%

95%

2.5%
90%
2.7%
2.9%
85%
3.1%
3.3%
80%
Probability (%)

3.5%
3.7%
75% 3.9%
4.1%
70% 4.3%
4.5%
65% 4.7%
4.9%
60% 5.1%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): Current USP Test (SE: 2.9 – 5.6, SM: 3.6 – 3.8)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 2.9-5.5, SM = 3.7)

100%

95%

2.9%
90%
3.1%
3.3%
85%
3.5%
3.7%
80%
Probability (%)

3.9%
4.1%
75% 4.3%
4.5%
70% 4.7%
4.9%
65% 5.1%
5.3%
60% 5.5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing Current USP Capsule Content Uniformity Test (N = 3x20 = 60, SE = 3.0-5.6, SM = 3.7)

100%

95%

3%
90%
3.2%
3.4%
85%
3.6%
3.8%
80%
Probability (%)

4%
4.2%
75% 4.4%
4.6%
70% 4.8%
5%
65% 5.2%
5.4%
60% 5.6%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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 INSTITUTE OF VALIDATION TECHNOLOGY
Sampling Plan 2 (3 x 20): New USP Test (SE: 2.3 – 5.0, SM: 3.6 – 3.8)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.3-4.9, SM = 3.7)

100%

95%

2.3%
90%
2.5%
2.7%
85%
2.9%
3.1%
80%
Probability (%)

3.3%
3.5%
75% 3.7%
3.9%
70% 4.1%
4.3%
65% 4.5%
4.7%
60% 4.9%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0
CU Sample Mean (% LC)

Probability of Passing New USP 29 Content Uniformity Test (N = 3x20 = 60, SE = 2.4-5.0, SM = 3.7)

100%

95%

2.4%
90%
2.6%
2.8%
85%
3%
3.2%
80%
Probability (%)

3.4%
3.6%
75% 3.8%
4%
70% 4.2%
4.4%
65% 4.6%
4.8%
60% 5%

55%

50%
95.0
95.2
95.4
95.6
95.8
96.0
96.2
96.4
96.6
96.8
97.0
97.2
97.4
97.6
97.8
98.0
98.2
98.4
98.6
98.8
99.0
99.2
99.4
99.6
99.8
100.0
100.2
100.4
100.6
100.8
101.0
101.2
101.4
101.6
101.8
102.0
102.2
102.4
102.6
102.8
103.0
103.2
103.4
103.6
103.8
104.0
104.2
104.4
104.6
104.8
105.0

CU Sample Mean (% LC)

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63/63