Accessed from 10.6.1.

1 by schering on Sun Sep 13 20:20:56 EDT 2015

USP 38 Official Monographs / Castor 2633

Instrumental conditions Cascara Sagrada, as a very coarse powder 1000 g

(See Spectrophotometry and Light-Scattering 851.)
Mode: Visible
Analytical wavelength: 515 nm
Cell: 1 cm
Blank: Methanol
Analysis
Sample: Sample solution
Prepare as directed for Analysis in Content of Total Hy-
droxyanthracene Derivatives, except to pipet 20 mL of
Sample solution.
Determine the absorbance, and calculate the percent-
age of cacarosides with respect to the content of total
hydroxyanthracene derivatives in the nominal amount
of Cascara Sagrada Extract in the portion of Tablets
powder taken:
Result = (AU/THD) F 100
AU = absorbance of the Sample solution
THD = weight of total hydroxyanthracene derivatives
(mg)
F = conversion factor, 103.5. [NOTEThis conver-
sion factor considers an absorptivity of 16.1
for cascaroside A, and the dilutions to pre-
pare the solution for analysis.]
Acceptance criteria: NLT 50% of the content of total
hydroxyanthracene derivatives are cascarosides, calcu-
lated as cascaroside A.
PERFORMANCE TESTS
DISINTEGRATION 701: 60 min
UNIFORMITY OF DOSAGE UNITS 905: Meet the
requirements
Magnesium Oxide 120 g
Suitable sweetening agent(s)
Suitable essential oils(s)
Suitable flavoring agent(s)
Alcohol 200 mL
Purified Water,
a sufficient quantity, to make 1000 mL
Mix the Cascara Sagrada with Magnesium Oxide, moisten it
uniformly with 2000 mL of boiling water, and set it aside
in a shallow container for 48 h, stirring occasionally. Pack
it in a percolator, and percolate with boiling water until
the material is exhausted. Evaporate the percolate, at a
temperature not exceeding 100, to 750 mL, and at once
dissolve in it the flavoring agent(s). When the liquid has
cooled, add the Alcohol, in which the sweetening agent(s)
and oils have been dissolved, and add sufficient water to
make the Aromatic Fluidextract measure 1000 mL. Mix.
OTHER COMPONENTS
ALCOHOL DETERMINATION 611: 18%20% of C2H5OH,
determined by the gasliquid chromatographic method,
using acetone as the internal standard
ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in tight, light-resistant
containers, and avoid exposure to direct sunlight and to
excessive heat.
.

Castor Oil
ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in tight containers; if DEFINITION
the Tablets are coated, well-closed containers may be Castor Oil is the fixed oil obtained from the seed of Ricinus

USP Monographs
used. communis L. (Fam. Euphorbiaceae). It contains no added
substances.
IMPURITIES
.

Cascara Sagrada Fluidextract Delete the following:

DEFINITION HEAVY METALS, Method II 231: NMT 10 ppm (Official 1-
Prepare Cascara Sagrada Fluidextract as follows. To 1000 g
.

of coarsely ground Cascara Sagrada add 3000 mL of boil-
ing water, and allow to macerate in a suitable percolator
for 2 h. Allow the percolation to proceed at a moderate
rate, gradually adding boiling water until the drug is prac-
tically exhausted of its active principles. Evaporate the
percolate on a water bath or in a vacuum still to NMT
800 mL. Cool, add 200 mL of alcohol and, if necessary,
add sufficient water to make the product measure
1000 mL. Mix.
OTHER COMPONENTS
ALCOHOL DETERMINATION, Method I 611: 18.0%20.0%
of C2H5OH
ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in tight, light-resistant
containers, and avoid exposure to direct sunlight and to
excessive heat.
.
Dec-2015)
SPECIFIC TESTS
SPECIFIC GRAVITY 841: 0.9570.961
DISTINCTION FROM MOST OTHER FIXED OILS: It is only
partly soluble in solvent hexane (distinction from most
other fixed oils), but it yields a clear liquid with an equal
volume of alcohol (foreign fixed oils).
FATS AND FIXED OILS, Free Fatty Acids 401: The free fatty
acids in 10 g require NMT 3.5 mL of 0.10 N sodium hy-
droxide for neutralization.
FATS AND FIXED OILS, Hydroxyl Value 401
Free acid determination
Sample: 10 g
Titrimetric system
(See Titrimetry 541.)
Mode: Direct titration
Titrant: 0.5 N alcoholic potassium hydroxide VS
Endpoint detection: Visual
Analysis: Transfer the Sample to a 250-mL conical
flask, add 10 mL of pyridine that has been neutralized
previously to phenolphthalein, and swirl to mix. Add
1 mL of phenolphthalein TS, and titrate with Titrant to

Aromatic Cascara Fluidextract a faint pink endpoint. Record the volume of Titrant
consumed (VA).
DEFINITION Hydroxyl value determination
Prepare Aromatic Cascara Fluidextract as follows. Sample: 2 g
Blank: 5.0 mL of a freshly prepared mixture of 1 vol-
ume of acetic anhydride and 3 volumes of pyridine

Official from August 1, 2015

Copyright (c) 2015 The United States Pharmacopeial Convention. All rights reserved.
 Accessed from 10.6.1.1 by schering on Sun Sep 13 20:20:56 EDT 2015
2634 Castor / Official Monographs
Titrimetric system
(See Titrimetry 541.)
Mode: Residual titration
Titrant: 0.5 N alcoholic potassium hydroxide VS
Endpoint detection: Visual
Analysis: Transfer the Sample to a glass-stoppered,
250-mL conical flask. Add 5.0 mL of a freshly prepared
mixture of 1 volume of acetic anhydride and 3
volumes of pyridine, and swirl to mix. Connect the
flask to a reflux condenser, and heat on a steam bath
for 2 h. Add 10 mL of water through the condenser,
swirl to mix, heat on a steam bath for an additional 10
min, and allow to cool to room temperature. Add
through the condenser 15 mL of normal butyl alcohol
that has been neutralized previously to phenolphthal-
ein, remove the condenser, and wash the tip of the
condenser and the sides of the flask with an additional
10 mL of neutralized normal butyl alcohol. Add 1 mL
of phenolphthalein TS, and titrate with Titrant to a
faint pink endpoint.
Calculate the hydroxyl value in the portion of Oil
taken:
Result = {[VB + (W VA/WA) VT] Mr N}/W
VB = volume of Titrant consumed by the Blank (mL)
W = sample weight from the hydroxyl value
determination (g)
VA = volume of Titrant consumed by the Sample in
the free acid determination (mL)
WA = sample weight from the free acid
determination (g)
VT = volume of Titrant consumed by the Sample in
the hydroxyl value determination (mL)
Mr = milliequivalent weight of potassium hydroxide,
56.11 mg/mEq
N = actual normality of the Titrant
Acceptance criteria: 160168
USP Monographs
FATS AND FIXED OILS, Iodine Value 401: 8388
FATS AND FIXED OILS, Saponification Value 401: 176182
ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in tight containers,
and avoid exposure to excessive heat.
.
Castor Oil Capsules
DEFINITION
Castor Oil Capsules contain NLT 90.0% and NMT 110.0%
of the labeled amount of castor oil, calculated from the
tests for Weight Variation and Specific Gravity.
IDENTIFICATION
A. INFRARED ABSORPTION 197S
Standard solution: 40 mg/mL of Castor Oil in
chloroform
Sample solution: 40 mg/mL of the oil from Capsules in
chloroform
Acceptance criteria: Meet the requirements
PERFORMANCE TESTS
UNIFORMITY OF DOSAGE UNITS 905: Meet the
requirements
SPECIFIC TESTS
SPECIFIC GRAVITY 841
Sample: Capsule contents
Acceptance criteria: 0.9570.961
FATS AND FIXED OILS, Free Fatty Acids 401: The free fatty
acids in 10 g require NMT 3.5 mL of 0.10 N sodium hy-
droxide for neutralization.
Official from August 1, 2015
Copyright (c) 2015 The United States Pharmacopeial Convention. All rights reserved.
USP 38
FATS AND FIXED OILS, Hydroxyl Value 401
Free acid determination: Determine the amount of
free acid in the Capsule contents.
Sample: 10 g of Capsule contents
Titrimetric system
(See Titrimetry 541.)
Mode: Direct titration
Titrant: 0.5 N alcoholic potassium hydroxide VS
Endpoint detection: Visual
Analysis 1: Transfer the Sample to a 250-mL conical
flask, add 10 mL of pyridine that has been neutralized
previously to phenolphthalein, and swirl to mix. Add
1 mL of phenolphthalein TS, and titrate with Titrant to
a faint pink endpoint. Record the volume of Titrant
consumed.
Hydroxyl value determination: Determine the hy-
droxyl value of the Capsule contents.
Sample: 2 g from the Capsule contents
Blank: 5.0 mL of a freshly prepared mixture of 1 vol-
ume of acetic anhydride and 3 volumes of pyridine
Titrimetric system
(See Titrimetry 541.)
Mode: Residual titration
Titrant: 0.5 N alcoholic potassium hydroxide VS
Endpoint detection: Visual
Analysis 2: Transfer the Sample to a glass-stoppered,
250-mL conical flask. Add 5.0 mL of a freshly prepared
mixture of 1 volume of acetic anhydride and 3
volumes of pyridine, and swirl to mix. Connect the
flask to a reflux condenser, and heat on a steam bath
for 2 h. Add 10 mL of water through the condenser,
swirl to mix, heat on a steam bath for an additional 10
min, and allow to cool to room temperature. Add
through the condenser 15 mL of normal butyl alcohol
that previously has been neutralized to phenolphthal-
ein, remove the condenser, and wash the tip of the
condenser and the sides of the flask with an additional
10 mL of neutralized normal butyl alcohol. Add 1 mL
of phenolphthalein TS, and titrate with Titrant to a
faint pink endpoint.
Calculate the hydroxyl value in the portion of Capsule
contents taken:
Result = (Mr N/W) [B + (W A/C) T]
Mr = milliequivalent weight of potassium hydroxide,
56.11 mg/mEq
N = actual normality of the Titrant
W = Sample weight for the hydroxyl determination
(g)
B = Titrant volume consumed by the Blank (mL)
A = Titrant volume consumed by the Sample in the
free acid determination (mL)
C = Sample weight for the free acid determination
(g)
T = Titrant volume consumed by the Sample in the
hydroxyl determination (mL)
Acceptance criteria: 160168 in mg of KOH/g of
Capsule content or hydroxyl value
FATS AND FIXED OILS, Iodine Value 401
Sample: Capsule contents
Acceptance criteria: 8388
FATS AND FIXED OILS, Saponification Value 401
Sample: Capsule contents
Acceptance criteria: 176182
ADDITIONAL REQUIREMENTS
PACKAGING AND STORAGE: Preserve in tight containers,
preferably at controlled room temperature.