Laboratory

Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,

Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard

ISO/IEC 17025: 2005

Discipline
Certificate Number
Last Amended on

Chemical Testing
T-1752
-

S. No. Product /
Material of Test

Specific Test Performed

Range of Testing /
Limits of Detection

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Colour

IS 8768: 2000 (RA 2006)

5.0 HU to 200 HU.

Crystallization Point

IS 695: 1986 (RA 2008)

14.0 C to 16.4 C

Formic Acid

IS 695: 1986 (RA 2008)

0.01 % to 0.350 %

Acetaldehyde

ASTM D2191-06, Page. 104

0.0005 % to 0.10 %

Acetic Acid Content

BS 576 (Part 2) : 1988

98.5 % to 99.99 %

Water Content

IS 2362: 1993 (RA 2010)

0.010 % to 2.0 %

Chloride

IS 695: 1986 (RA 2008)

Qualitative

Sulphate

IS 695: 1986 (RA 2008)

Qualitative

Heavy Metal

IS 695: 1986 (RA 2008)

Qualitative

Iron Content

IS 695: 1986 (RA 2008)

Qualitative

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Colour

IS 8768: 2000 (RA 2006)

5.0 HU to 200 HU.

Reducing Substances

FPTO-022 (w.e.f. 01.06.13)

Qualitative

Chloride

IS 1235: 1988 (RA 2009)

Qualitative

Sulphate

IS 1235: 1988 (RA 2009)

Qualitative

Purity

98 % to 100 %

Appearance

FPTO-021
(w.e.f. 25.08.14)
FPTO-001(w.e.f. 25.11.14)

Colour

IS 8768: 2000 (RA 2006)

5.0 HU to 200 HU

INDUSTRIAL & FINE CHEMICALS

1.

Acetic Acid

3.

Acetic Anhydride

Ethyl Acetate

Rini Narayan
Convenor

23.04.2016
22.04.2018
1 of 16

Test Method Specification

against which tests are
performed

I.

2.

Issue Date
Valid Until
Page

Qualitative

N. Venkateswaran
Program Manager

Laboratory

Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,

Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard

ISO/IEC 17025: 2005

Discipline
Certificate Number
Last Amended on

Chemical Testing
T-1752
-

S. No. Product /
Material of Test

Issue Date
Valid Until
Page

23.04.2016
22.04.2018
2 of 16

Specific Test Performed

Test Method Specification

against which tests are
performed

Range of Testing /
Limits of Detection

Odour

FPTO-013
(w.e.f. 01.08.14)
IS 2362: 1993 (RA 2010)

Qualitative

IS 229: 1993 (RA 2009)

0.0010 % to 0.50 %

FPTO-027
(w.e.f. 01.10.13)

98 - 100 %

Purity
Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Acidity

ASTM D2086-03,Page97

0.0020 % to 0.50 %

Aldehyde (As Acetaldehyde)

RMTO - 020 (w.e.f. 01.10.13)

0.00075 % to 1.0 %

Moisture

IS 2362: 1993 (RA 2010)

0.0010 % to 2.0 %

Vinyl Acetate Monomer

RMTO - 020
(w.e.f. 01.10.13)

0.025 % to 99.99 %

Inhibitor Content

ASTM D2193-06, Page. 111

0.0002 % to 0.0030 %

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Colour (Pt-Co Scale)

IS 8768: 2000 (RA 2006)

5 HU to 200 HU

Acidity As Formic Acid

IS 3321: 1973 (RA 2006)

0.0010 % to 0.50 %

Aldehyde Content As HCHO

IS 3321: 1973 (RA 2006)

36.0 % to 38.0 %

Methanol
Appearance

IS 3321: 1973 (RA 2006)

FPTO-001(w.e.f. 25.11.14)

1.0 % to 10.0 %
Qualitative

Solubility

USP 38

Qualitative

Moisture

IS 2362: 1993 (RA 2010)

0.0010 % to 2.0 %

Moisture

0.01 % to 2.0 %

Acidity

4.

5.

6.

Vinyl Acetate
Monomer

Formaldehyde37 %

Pyridine 1

Rini Narayan
Convenor

N. Venkateswaran
Program Manager

Laboratory

Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,

Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard

ISO/IEC 17025: 2005

Discipline
Certificate Number
Last Amended on

Chemical Testing
T-1752
-

S. No. Product /
Material of Test

7.

8.

Issue Date
Valid Until
Page

23.04.2016
22.04.2018
3 of 16

Specific Test Performed

Test Method Specification

against which tests are
performed

Range of Testing /
Limits of Detection

Colour

IS 8768: 2000 (RA 2006)

5 HU to 200 HU

Purity

FPTO-050 (w.e.f.01.10.13)

98 - 100 %

Identification (By IR)

BP 2016 (Appendix IIA)

Qualitative

Strong Bases (As Ammonia)

FPTO-034 (w.e.f.28.08.14)

0.0005 % to 0.010 %

Purity

ISBT (Procedure-2.0)
(2nd Revision -30.11.10)

98.00 -100 %

Moisture

ISBT (Procedure-3.0)
(2nd Revision -30.11.10)

0.0003 % to 0.0140 %

Nitrose Gases

ISBT (Procedure-7.0)
(2nd Revision -30.11.10)

0.00005 % to 0.0500%

Appearance In Water

ISBT (Procedure-16)
(2nd Revision -30.11.10)

Qualitative

Odour

ISBT (Procedure-15.0)
(2nd Revision -30.11.10)

Qualitative

Taste & Odour

ISBT (Procedure-16.0)
(2nd Revision -30.11.10)

Qualitative

Pyridine ACS

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Pyridine ACS

Colour
Water Solubility

IS 8768: 2000 (RA 2006)

USP 38

5 HU to 200 HU
Qualitative

Moisture Content

IS 2362: 1993 (RA 2010)

0.0050 % to 2.0 %

Purity

FPTO-050 (w.e.f.01.10.13)

98.00 -100 %

Chlorides

USP 38 <221>

Qualitative

Sulphates

USP 38 <221>

Qualitative

Carbon dioxide

Rini Narayan
Convenor

N. Venkateswaran
Program Manager

Laboratory

Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,

Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard

ISO/IEC 17025: 2005

Discipline
Certificate Number
Last Amended on

Chemical Testing
T-1752
-

S. No. Product /
Material of Test

9.

10.

11.

Beta Picoline

Alpha Picoline
Alpha Picoline

Gamma Picoline

Rini Narayan
Convenor

Issue Date
Valid Until
Page

23.04.2016
22.04.2018
4 of 16

Specific Test Performed

Test Method Specification

against which tests are
performed

Range of Testing /
Limits of Detection

Ammonia (As NH3)

FPTO-034
(w.e.f. 28.08.14)

0.0005 % to 0.010 %

Residue on evaporation

FPTO-322
(w.e.f. 01.10.13)

0.0005 % to 0.100 %

Reducing Substances

IS 8058: 1976 (RA 2006)

Qualitative
(Permanent Colour
Persist for 30 Minutes)

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Solubility

USP 38

Qualitative

Moisture Content

IS 2362: 1993 (RA 2010)

0.0050 % to 2.0 %

Purity

FPTO-049 (w.e.f.07.04.14)

98.00 -100 %

Gamma Picoline

FPTO-049 (w.e.f.07.04.14)

0.062 % to 1.0 %

2- Ethyl Pyridine

FPTO-049 (w.e.f.07.04.14)

0.048 % to 1.0 %

Alpha Picoline

FPTO-049 (w.e.f.07.04.14)

0.043 % to 1.0 %

Appearance
Solubility

FPTO-001(w.e.f. 25.11.14)
USP 38

Qualitative
Qualitative

Moisture Content

IS 2362: 1993 (RA 2010)

0.0050 % to 2.0 %

Purity

FPTO-051
(w.e.f.01.10.13)

98.00 -100 %

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Solubility

USP 38

Qualitative

Moisture Content

IS 2362: 1993 (RA 2010)

0.0050 % to 2.0 %

N. Venkateswaran
Program Manager

Laboratory

Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,

Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard

ISO/IEC 17025: 2005

Discipline
Certificate Number
Last Amended on

Chemical Testing
T-1752
-

S. No. Product /
Material of Test

12.

13.

14.

15.

Isonipecotic Acid

3-Cyanopyridine

Pyridine
Hydrobromide

Pyridine
Hydrochloride

Rini Narayan
Convenor

Issue Date
Valid Until
Page

23.04.2016
22.04.2018
5 of 16

Specific Test Performed

Test Method Specification

against which tests are
performed

Range of Testing /
Limits of Detection

Purity

FPTO-048 (w.e.f.01.10.13)

98.00 % to 100 %

Description

FPTO-001(w.e.f. 25.11.14)

Qualitative

Solubility

USP 38

Qualitative

Water Content

IS 2362: 1993

0.0050 % to 2.0 %

Assay

FPTO-092
(w.e.f. 01.10.13)

80.0 % to 102 %

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Solubility

USP 38

Qualitative

Moisture

IS 2362: 1993 (RA 2010)

0.0050 % to 2.0 %

Melting Range

IP 2014, Page. 164

40 C to 100 C

Purity

FPTO-054 (w.e.f.01.10.13)

98.00 -100 %

4-Cyanopyridine
Appearance

FPTO-054 (w.e.f.01.10.13)
FPTO-001(w.e.f. 25.11.14)

0.01 % to 1.0 %
Qualitative

Solubility

USP 38

Qualitative

pH of 5% Aqueous Solution

ASTM E 70-07, Page. 348

(Re-approved 2002)

1.0 to 13.0

Water Content

IS 2362: 1993 (RA 2010)

0.0010 % to 2.0 %

Free Pyridine

FPTO-087 (w.e.f.01.10.13)

0.050 % to 1.0 %

Assay

FPTO-039 (w.e.f. 01.10.13)

80.0 % to 102 %

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

N. Venkateswaran
Program Manager

Laboratory

Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,

Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard

ISO/IEC 17025: 2005

Discipline
Certificate Number
Last Amended on

Chemical Testing
T-1752
-

S. No. Product /
Material of Test

16.

Niacin

Niacin

17.

Niacinamide

Rini Narayan
Convenor

Issue Date
Valid Until
Page

23.04.2016
22.04.2018
6 of 16

Specific Test Performed

Test Method Specification

against which tests are
performed

Range of Testing /
Limits of Detection

Solubility

USP 38

Qualitative

pH of 5% Aqueous Solution

ASTM E 70-07, Page. 348

(Re-approved 2002)

1.0 to 13.0

Water Content

IS 2362: 1993 (RA 2010)

0.0050 % to 2.0 %

Free Pyridine

FPTO-087 (w.e.f.01.10.13)

0.02 % to 5.0 %

Assay

FPTO-040 (w.e.f.25.10.15)

80.0 % to 102 %

Description

USP 38

Qualitative

Solubility

USP 38

Qualitative

Assay

USP 38

90 % to 102 %

Identification by IR

USP 38, <197M>

Qualitative

Identification by UV
Loss on drying

USP 38, <197U>

USP 38, <731>

Qualitative
0.050 % to 2.0 %

Residue on ignition

USP 38, <281>

0.02 % to 1.0 %

Chloride

USP 38, <221>

Qualitative

Sulphate

USP 38, <221>

Qualitative

Description

USP 38

Qualitative

Solubility

USP 38

Qualitative

Assay

USP 38

80 % to 102 %

Melting Range

USP 38, <741>

40 C to 200 C

Identification by IR

USP 38, <197K>

Qualitative

N. Venkateswaran
Program Manager

Laboratory

Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,

Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard

ISO/IEC 17025: 2005

Discipline
Certificate Number
Last Amended on

Chemical Testing
T-1752
-

S. No. Product /
Material of Test

18.

19.

4-(Dimethyl
amino) pyridine

2-Aminopyridine

Rini Narayan
Convenor

Issue Date
Valid Until
Page

23.04.2016
22.04.2018
7 of 16

Specific Test Performed

Test Method Specification

against which tests are
performed

Range of Testing /
Limits of Detection

Identification by UV

USP 38, <197U>

Qualitative

Loss On Drying

USP 38, <731>

0.05 % to 1.0 %

Residue On Ignition

USP 38, <281>

0.01 % to 1.0 %

Appearance

FPTO-001 (w.e.f. 25.11.14)

Qualitative

Melting Range

IP 2014, Page. 164

40 C to 200 C

Water Content

IS 2362: 1993 (RA 2010)

0.0010 % to 2.0 %

Purity

FPTO-062 (w.e.f.01.10.13)

098.00 -100 %

Assay

FPTO-140 (w.e.f.01.10.13)

80.0 % to 102.0 %

Identification by IR
Appearance

BP 2016 (Appendix IIA)

FPTO-001(w.e.f. 25.11.14)

Qualitative
Qualitative

Solubility

USP 38, Page. 994

Qualitative

Identification by GC

FPTO-056
(w.e.f.01.10.13)

Qualitative

Identification by IR

BP 2016
(Appendix IIA)

Qualitative

Melting Range

IP 2014, Page. 164

40 C to 200 C

Water Content

IS 2362: 1993 (RA 2010)

0.0050 % to 2.0 %

Assay

FPTO-080 (w.e.f.01.10.13)

80.0 % to 102.0 %

Purity

FPTO-056 (w.e.f.01.10.13)

98.00 -100 %

Sulphated Ash

BP 2016(Appendix IX A)

0.04 % to 5.0 %

Residue on ignition

IP 2014, Page. 163

0.005 % to 5.0 %

N. Venkateswaran
Program Manager

Laboratory

Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,

Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard

ISO/IEC 17025: 2005

Discipline
Certificate Number
Last Amended on

Chemical Testing
T-1752
-

S. No. Product /
Material of Test

20.

21.

22.

Piperidine

Picolinic acid

2-Amino-4Methyl pyridine

Rini Narayan
Convenor

Issue Date
Valid Until
Page

23.04.2016
22.04.2018
8 of 16

Specific Test Performed

Test Method Specification

against which tests are
performed

Range of Testing /
Limits of Detection

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Colour

IS 8768: 2000 (RA 2006)

5 HU to 200 HU

Solubility

USP 38

Qualitative

Specific Gravity

IP 2014, Page. 208

0.70 to 1.0

Water Content

IS 2362: 1993 (RA 2010)

0.0010 % to 2.0 %

Purity

FPTO-059 (w.e.f.01.10.13)

98.00 -100 %

Pyridine
Appearance

FPTO-059 (w.e.f.01.10.13)
USP 38

0.0025 % to 1.0 %
Qualitative

Solubility

USP 38

Qualitative

Melting Range

IP 2014, Page. 164

40 C to 200 C

Sulphated Ash

BP 2016(Appendix IX A)

0.01 % to 5.0 %

Water Content

IS 2362: 1993 (RA 2010)

0.0010 % to 2.0 %

Assay

FPTO-064
(w.e.f. 01.10.13)

80.0 % to 100 %

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Identification by IR

BP 2016(Appendix II A)

Qualitative

Water Content

IS 2362: 1993 (RA 2010)

0.0050 % to 2.0 %

Melting Range

IP 2014, Page. 164

40 C to 200 C

Assay

FPTO-086 (w.e.f.01.10.13)

5.0 % to 102.0 %

Purity

FPTO-058 (w.e.f.20.06.15)

98.00 -100 %

N. Venkateswaran
Program Manager

Laboratory

Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,

Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard

ISO/IEC 17025: 2005

Discipline
Certificate Number
Last Amended on

Chemical Testing
T-1752
-

S. No. Product /
Material of Test

23.

2-Amino-5Methyl pyridine

2-Amino-5Methyl pyridine
24.

25.

2-Amino-6Methyl Pyridine

3-Acetyl Pyridine

Rini Narayan
Convenor

Issue Date
Valid Until
Page

23.04.2016
22.04.2018
9 of 16

Specific Test Performed

Test Method Specification

against which tests are
performed

Range of Testing /
Limits of Detection

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Water Content

IS 2362: 1993 (RA 2010)

0.005 % to 2.0 %

Purity

FPTO-074 (w.e.f.01.10.13)

98.00 -100 %

Assay

FPTO-075 (w.e.f.01.10.13)

80.0 % to 102.0 %

Melting Range

IP 2014, Page. 164

40C to 200 C

Identification by GC

FPTO-074 (w.e.f.01.10.13)

Qualitative

Identification by IR

BP 2016(Appendix II A)

Qualitative

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Identification by IR

BP 2016(Appendix II A)

Qualitative

Water Content

IS 2362: 1993 (RA 2010)

0.005 % to 2.0 %

Assay

FPTO-085 (w.e.f.01.10.13)

80.0 % to 102.0 %

Purity

FPTO-057 (w.e.f.01.10.13)

98.00 -100 %

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Identification by IR

BP 2016(Appendix II A)

Qualitative

Water Content

IS 2362: 1993 (RA 2010)

0.005 % to 2.0 %

Purity

FPTO-061 (w.e.f.15.05.15)

98.00 -100 %

4-Acetyl Pyridine

FPTO-061 (w.e.f.15.05.15)

0.001 % to 1.0 %

Toluene

FPTO-061 (w.e.f.15.05.15)

0.001 % to 1.0 %

Total Impurities

FPTO-061 (w.e.f.15.05.15)

0.001 % to 1.0 %

N. Venkateswaran
Program Manager

Laboratory

Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,

Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard

ISO/IEC 17025: 2005

Discipline
Certificate Number
Last Amended on

Chemical Testing
T-1752
-

S. No. Product /
Material of Test

26.

3,5-Dimethyl
Piperidine

3,5-Dimethyl
Piperidine
27.

28.

29.

30.

3-(Amino methyl)
pyridine

3-Pyridyl acetic
acid

2-(Amino methyl)
pyridine

2,3,5 Collidine

Rini Narayan
Convenor

Issue Date
Valid Until
Page

23.04.2016
22.04.2018
10 of 16

Specific Test Performed

Test Method Specification

against which tests are
performed

Range of Testing /
Limits of Detection

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Water Content

IS 2362: 1993 (RA 2010)

0.005 % to 2.0 %

Specific Gravity

IP 2014, Page. 208

0.70 to 1.0

Purity
A) Cis Isomer

FPTO-060 (w.e.f.18.06.15)
FPTO-060 (w.e.f.18.06.15)

98.00 -100 %
70.0 % to 95.0 %

B) Trans Isomer

FPTO-060 (w.e.f.18.06.15)

5 % to 30 %

Appearance

FPTO-001 (w.e.f. 25.11.14)

Qualitative

Moisture

IS 2362: 1993 (RA 2010)

0.005 % to 2.0 %

Purity

FPTO-120 (w.e.f.19.11.13)

98.00 -100 %

Description

FPTO-001 (w.e.f. 25.11.14)

Qualitative

Identification by HPLC

FPTO-155 (w.e.f.08.04.13)

Qualitative

Loss on drying

IP 2014, Page. 162

0.05 % to 2.0 %

Purity

FPTO-155 (w.e.f.10.04.13)

98.00 -100 %

Assay

FPTO-155 (w.e.f.10.04.13)

5.0 % to 100 %

Single Known Impurity

FPTO-155 (w.e.f.10.04.13)

0.001 % to 1.0 %

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Moisture

IS 2362: 1993 (RA 2010)

0.0010 % to 2.0 %

Purity

FPTO-159 (w.e.f.01.10.13)

98.00 -100 %

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

N. Venkateswaran
Program Manager

Laboratory

Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,

Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard

ISO/IEC 17025: 2005

Discipline
Certificate Number
Last Amended on

Chemical Testing
T-1752
-

S. No. Product /
Material of Test

31.

32.

5-Methyl
Nicotinic Acid

Cetyl pyridinium
Chloride
Monohydrate

Rini Narayan
Convenor

Issue Date
Valid Until
Page

23.04.2016
22.04.2018
11 of 16

Specific Test Performed

Test Method Specification

against which tests are
performed

Range of Testing /
Limits of Detection

Moisture

IS 2362: 1993 (RA 2010)

0.005 % to 2.0 %

Purity

FPTO-047 (w.e.f.01.10.13)

98.00 -100 %

Refractive Index
Appearance

IP 2014, Page. 203

FPTO-001(w.e.f. 25.11.14)

1.32 % to 1.70
Qualitative

Moisture

IS 2362: 1993 (RA 2010)

0.0050 % to 2.0 %

Loss on drying

IP 2014, Page. 162

0.05 % to 2.0 %

Purity by HPLC

FPTO 190 (w.e.f.01.10.13)

98.00 -100 %

Melting Range

IP 2014, Page. 164

40 C to 300 C

Assay

FPTO 197 (w.e.f.01.10.13)

5.0 % to 100 %

Sulphated Ash

BP 2016(Appendix IX A)

0.01 % to 5.0 %

Total related impurities

FPTO 190 (w.e.f.01.10.13)

0.10 % to 2.0 %

Dinicotinic Acid

FPTO 190 (w.e.f.01.10.13)

0.00015 % to 1.0 %

Nicotinic Acid

FPTO 190 (w.e.f.01.10.13)

0.00015 % to 1.0 %

Unknown Individual Impurity

FPTO 190 (w.e.f.01.10.13)

0.005 % to 1.0 %

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Identification by IR

USP 38, <197K>

Qualitative

Identification by UV

USP 38, <197U>

Qualitative

Moisture

USP 38, <921>

0.005 % to 5.0 %

Melting Range

USP 38 <741>

40 C to 200 C

Pyridine

FPTO 267 (w.e.f.10.02.15)

0.00005 % to 0.0120%

N. Venkateswaran
Program Manager

Laboratory

Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,

Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard

ISO/IEC 17025: 2005

Discipline
Certificate Number
Last Amended on

Chemical Testing
T-1752
-

S. No. Product /
Material of Test

34.

35.

36.

23.04.2016
22.04.2018
12 of 16

Specific Test Performed

Test Method Specification

against which tests are
performed

Range of Testing /
Limits of Detection

Heavy Metals
Residue On Ignition

USP 38, Method II <231>

IP 2014, Page. 163

Qualitative
0.010 % to 5.0 %

Acidity

USP 38

Qualitative
(Pass / Fail)

Assay

USP 38

80.0 % to 102 %

Appearance of 1% Solution in
Water

Ph.Eur 7.0, Page. 1838

Qualitative

Appearance of 40% Soln in PEG

FPTO-268 (w.e.f.25.11.14)

Qualitative

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Water Content

IS 2362: 1993 (RA 2010)

0.0050 % to 2.0 %

Purity

FPTO-046 (w.e.f.01.10.13)

98.00 -100 %

Identification(by IR)

BP 2016(Appendix II A)

Qualitative

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Water Content

IS 2362: 1993 (RA 2010)

0.005 % to 2.0 %

Purity

FPTO-042 (w.e.f.10.10.13)

98.00 -100 %

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Water Content

IS 2362: 1993 (RA 2010)

0.0050 % to 2.0 %

Purity

FPTO-072 (w.e.f.01.10.13)

98.00 -100 %

2,5-Lutidine

Appearance

Visual (FPTO-001)
(w.e.f. 25.11.14)

Qualitative

2,5-Lutidine

Water Content

IS 2362: 1993 (RA 2010)

0.0050 % to 2.0 %

Cetyl pyridinium
Chloride
Monohydrate

33.

Issue Date
Valid Until
Page

2,4 6 Collidine

2,3-Lutidine

2,4-Lutidine

Rini Narayan
Convenor

N. Venkateswaran
Program Manager

Laboratory

Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,

Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard

ISO/IEC 17025: 2005

Discipline
Certificate Number
Last Amended on

Chemical Testing
T-1752
-

S. No. Product /
Material of Test

37.

38.

39.

40.

2,6 Lutidine

3,4 Lutidine

3,5-Lutidine

2,3,5Trichloropyridine

Rini Narayan
Convenor

Issue Date
Valid Until
Page

23.04.2016
22.04.2018
13 of 16

Specific Test Performed

Test Method Specification

against which tests are
performed

Range of Testing /
Limits of Detection

Purity

FPTO-073 (w.e.f.01.10.13)

98.00 -100 %

Specific Gravity

IP 2014, Page: 208

0.80 to 1.0

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Water Content

IS 2362: 1993 (RA 2010)

0.0050 % to 2.0 %

Purity

FPTO-041 (w.e.f.01.10.13)

98.00 -100 %

Identification(by IR)

BP 2016(Appendix II A)

Qualitative

Colour

IS 8768: 2000 (RA 2006)

5 HU to 200 HU

Solubility

USP 38, Page. 994

Qualitative
(Pass /Fail)

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Water Content

IS 2362: 1993 (RA 2010)

0.0050 % to 2.0 %

Purity

FPTO-044 (w.e.f.01.10.13)

98.00 -100 %

Solubility

USP 38

Qualitative

Weight / ml

IP 2014, Page. 208

0.800 to 1.100

Appearance

FPTO-001 (w.e.f. 25.11.14)

Qualitative

Water Content

IS 2362: 1993 (RA 2010)

0.005 % to 2.0 %

Purity

FPTO-043 (w.e.f.05.06.15)

98.00 -100 %

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Water Content

IS 2362: 1993 (RA 2010)

0.0010 % to 2.0 %

N. Venkateswaran
Program Manager

Laboratory

Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,

Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard

ISO/IEC 17025: 2005

Discipline
Certificate Number
Last Amended on

Chemical Testing
T-1752
-

S. No. Product /
Material of Test

41.

2-Pyridine
Carboxaldehyde

2-Pyridine
Carboxaldehyde
42.

Azacyclonol

Rini Narayan
Convenor

Issue Date
Valid Until
Page

23.04.2016
22.04.2018
14 of 16

Specific Test Performed

Test Method Specification

against which tests are
performed

Range of Testing /
Limits of Detection

Identification(by GC)

FPTO-169 (w.e.f.01.10.13)

Qualitative

Purity by GC

FPTO-169 (w.e.f.01.10.13)

98.00 -100 %

3,5-Di Chloro Pyridine-2-ol

FPTO-169 (w.e.f.01.10.13)

0.0025 % to 2.0 %

2,5-Di Chloro Pyridine

FPTO-169 (w.e.f.01.10.13)

0.0025 % to 2.0 %

2,3-Di Chloro Pyridine

FPTO-169 (w.e.f.01.10.13)

0.0025 % to 2.0 %

2,3-Di Chloro-N-N-DMAP

FPTO-169 (w.e.f.01.10.13)

0.0025 % to 3.0 %

Additional Organic by Product

FPTO-169 (w.e.f.01.10.13)

0.01 % to 2.0 %

Any Single Impurity

FPTO-169 (w.e.f.01.10.13)

0.01 % to 2.0 %

Content of Toluene

FPTO-169 (w.e.f.01.10.13)

0.0025 % to 2.0 %

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Water Content

IS 2362: 1993 (RA 2010)

0.005 % to 2.0 %

Solubility

USP 38

Qualitative

Density

IP 2014, Page: 208

1.0 to 1.5

Refractive Index

IP 2014, Page: 203

1.32 to 1.70

Acidity

FPTO-170 (w.e.f.01.10.13)

0.05 % to 2.0 %

Purity
Assay

FPTO-161 (w.e.f.01.10.13)
FPTO-222
(w.e.f.01.10.13)

98.00 % to 100 %
80.0 % to 102 %

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Identification(by IR)

BP 2016(Appendix II A)

Qualitative

N. Venkateswaran
Program Manager

Laboratory

Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,

Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard

ISO/IEC 17025: 2005

Discipline
Certificate Number
Last Amended on

Chemical Testing
T-1752
-

S. No. Product /
Material of Test

Issue Date
Valid Until
Page

23.04.2016
22.04.2018
15 of 16

Specific Test Performed

Test Method Specification

against which tests are
performed

Range of Testing /
Limits of Detection

Melting Range

IP 2014, Page. 164

40 C to 200 C

Purity

FPTO-148 (w.e.f.20.11.14)

98.00 -100 %

Assay

FPTO-150 (w.e.f.01.10.13)

80.0 % to 105.0 %

Methanol

FPTO-256 (w.e.f.03.04.14)

0.001 % to 0.5%

Toluene

FPTO-256 (w.e.f.03.04.14)

0.0010 % to 0.10 %

Appearance

FPTO-001(w.e.f. 25.11.14)

Qualitative

Identification

FPTO-272
(w.e.f. 01.10.13)

Qualitative

Chromatographic Purity

FPTO-272
(w.e.f. 01.10.13)

2 % to 100 %

3-Chloro-2,5-Difluoro Pyridine

FPTO-272 (w.e.f. 01.10.13)

0.10 % to 15.0 %

Additional Organic By Products

FPTO-272 (w.e.f. 01.10.13)

0.10 % to 15.0 %

No. of Additional Organic by

Products
Solvent as Methyl Benzene

FPTO-272
(w.e.f. 01.10.13)
FPTO-272
(w.e.f. 01.10.13)

0.01 % to 1.0 %
(1.0 %)
0.05 % to 10.0 %

Additives Contents Of Fluoride

FPTO-273
(w.e.f. 01.10.13)

0.0005 % to 0.10 %

Residual Solvent

43.

5-Chloro-2,3Difluoro Pyridine
(CDFP)

Organic Byproducts

5-Chloro-2,3Difluoro Pyridine
(CDFP)

-X-X-X-X-X-X-X-X-X-X-X-X-X-XABBREVIATIONS:

Rini Narayan
Convenor

N. Venkateswaran
Program Manager

Laboratory

Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,

Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard

ISO/IEC 17025: 2005

Discipline
Certificate Number
Last Amended on

Chemical Testing
T-1752
-

S. No. Product /
Material of Test

S. No.
1
2
3
4
5
6
7
8

Specific Test Performed

Short Form
FPTO
IND-SU-WAD
ISBT
QC/FPTM
Ph.Eur
RMTO
NA
w.e.f

Rini Narayan
Convenor

Issue Date
Valid Until
Page
Test Method Specification
against which tests are
performed

23.04.2016
22.04.2018
16 of 16

Range of Testing /
Limits of Detection

Full Form
Finish Product Test method Organic intermediate
Customer Method (PepsiCo India)
International Society of Beverage Technologists
Quality Control/ Finish Product Test Method
European Pharmacopoeia
Raw Material test method Organic intermediate
Not Applicable
With effective from

N. Venkateswaran
Program Manager