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Laboratory Quality Control Laboratory, Jubilant Life Sciences Ltd.

, Bhartiagram,
Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard ISO/IEC 17025: 2005

Discipline Chemical Testing Issue Date 23.04.2016


Certificate Number T-1752 Valid Until 22.04.2018
Last Amended on - Page 1 of 16
S. No. Product / Specific Test Performed Test Method Specification Range of Testing /
Material of Test against which tests are Limits of Detection
performed

I. INDUSTRIAL & FINE CHEMICALS


1. Acetic Acid 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

2. Acetic Anhydride 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 FPTO-021 98 % to 100 %


(w.e.f. 25.08.14)
3. Ethyl Acetate Appearance FPTO-001(w.e.f. 25.11.14) Qualitative

Colour IS 8768: 2000 (RA 2006) 5.0 HU to 200 HU

Rini Narayan N. Venkateswaran


Convenor Program Manager
Laboratory Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,
Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard ISO/IEC 17025: 2005

Discipline Chemical Testing Issue Date 23.04.2016


Certificate Number T-1752 Valid Until 22.04.2018
Last Amended on - Page 2 of 16
S. No. Product / Specific Test Performed Test Method Specification Range of Testing /
Material of Test against which tests are Limits of Detection
performed

Odour FPTO-013 Qualitative


(w.e.f. 01.08.14)
Moisture IS 2362: 1993 (RA 2010) 0.01 % to 2.0 %

IS 229: 1993 (RA 2009) 0.0010 % to 0.50 %


Acidity
FPTO-027 98 - 100 %
Purity (w.e.f. 01.10.13)

4. Vinyl Acetate Appearance FPTO-001(w.e.f. 25.11.14) Qualitative


Monomer
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 0.025 % to 99.99 %


(w.e.f. 01.10.13)

Inhibitor Content ASTM D2193-06, Page. 111 0.0002 % to 0.0030 %

5. Formaldehyde- Appearance FPTO-001(w.e.f. 25.11.14) Qualitative


37 %
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 IS 3321: 1973 (RA 2006) 1.0 % to 10.0 %


6. Pyridine 1 Appearance FPTO-001(w.e.f. 25.11.14) Qualitative

Solubility USP 38 Qualitative

Moisture IS 2362: 1993 (RA 2010) 0.0010 % to 2.0 %

Rini Narayan N. Venkateswaran


Convenor Program Manager
Laboratory Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,
Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard ISO/IEC 17025: 2005

Discipline Chemical Testing Issue Date 23.04.2016


Certificate Number T-1752 Valid Until 22.04.2018
Last Amended on - Page 3 of 16
S. No. Product / Specific Test Performed Test Method Specification Range of Testing /
Material of Test against which tests are Limits of Detection
performed

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 %

7. Carbon dioxide Purity ISBT (Procedure-2.0) 98.00 -100 %


(2nd Revision -30.11.10)

Moisture ISBT (Procedure-3.0) 0.0003 % to 0.0140 %


(2nd Revision -30.11.10)

Nitrose Gases ISBT (Procedure-7.0) 0.00005 % to 0.0500%


(2nd Revision -30.11.10)

Appearance In Water ISBT (Procedure-16) Qualitative


(2nd Revision -30.11.10)

Odour ISBT (Procedure-15.0) Qualitative


(2nd Revision -30.11.10)

Taste & Odour ISBT (Procedure-16.0) Qualitative


(2nd Revision -30.11.10)

8. Pyridine ACS Appearance FPTO-001(w.e.f. 25.11.14) Qualitative

Colour IS 8768: 2000 (RA 2006) 5 HU to 200 HU


Pyridine ACS Water Solubility USP 38 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

Rini Narayan N. Venkateswaran


Convenor Program Manager
Laboratory Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,
Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard ISO/IEC 17025: 2005

Discipline Chemical Testing Issue Date 23.04.2016


Certificate Number T-1752 Valid Until 22.04.2018
Last Amended on - Page 4 of 16
S. No. Product / Specific Test Performed Test Method Specification Range of Testing /
Material of Test against which tests are Limits of Detection
performed

Ammonia (As NH3) FPTO-034 0.0005 % to 0.010 %


(w.e.f. 28.08.14)

Residue on evaporation FPTO-322 0.0005 % to 0.100 %


(w.e.f. 01.10.13)

Reducing Substances IS 8058: 1976 (RA 2006) Qualitative


(Permanent Colour
Persist for 30 Minutes)

9. Beta Picoline 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 %

10. Alpha Picoline Appearance FPTO-001(w.e.f. 25.11.14) Qualitative


Alpha Picoline Solubility USP 38 Qualitative

Moisture Content IS 2362: 1993 (RA 2010) 0.0050 % to 2.0 %

Purity FPTO-051 98.00 -100 %


(w.e.f.01.10.13)

11. Gamma Picoline 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 %

Rini Narayan N. Venkateswaran


Convenor Program Manager
Laboratory Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,
Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard ISO/IEC 17025: 2005

Discipline Chemical Testing Issue Date 23.04.2016


Certificate Number T-1752 Valid Until 22.04.2018
Last Amended on - Page 5 of 16
S. No. Product / Specific Test Performed Test Method Specification Range of Testing /
Material of Test against which tests are Limits of Detection
performed

Purity FPTO-048 (w.e.f.01.10.13) 98.00 % to 100 %

12. Isonipecotic Acid 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 80.0 % to 102 %


(w.e.f. 01.10.13)

13. 3-Cyanopyridine 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 FPTO-054 (w.e.f.01.10.13) 0.01 % to 1.0 %


14. Pyridine Appearance FPTO-001(w.e.f. 25.11.14) Qualitative
Hydrobromide
Solubility USP 38 Qualitative

pH of 5% Aqueous Solution ASTM E 70-07, Page. 348 1.0 to 13.0


(Re-approved 2002)

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 %

15. Pyridine Appearance FPTO-001(w.e.f. 25.11.14) Qualitative


Hydrochloride

Rini Narayan N. Venkateswaran


Convenor Program Manager
Laboratory Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,
Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard ISO/IEC 17025: 2005

Discipline Chemical Testing Issue Date 23.04.2016


Certificate Number T-1752 Valid Until 22.04.2018
Last Amended on - Page 6 of 16
S. No. Product / Specific Test Performed Test Method Specification Range of Testing /
Material of Test against which tests are Limits of Detection
performed

Solubility USP 38 Qualitative

pH of 5% Aqueous Solution ASTM E 70-07, Page. 348 1.0 to 13.0


(Re-approved 2002)

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 %

16. Niacin Description USP 38 Qualitative

Solubility USP 38 Qualitative

Assay USP 38 90 % to 102 %

Identification by IR USP 38, <197M> Qualitative

Identification by UV USP 38, <197U> Qualitative


Niacin Loss on drying USP 38, <731> 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

17. Niacinamide 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

Rini Narayan N. Venkateswaran


Convenor Program Manager
Laboratory Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,
Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard ISO/IEC 17025: 2005

Discipline Chemical Testing Issue Date 23.04.2016


Certificate Number T-1752 Valid Until 22.04.2018
Last Amended on - Page 7 of 16
S. No. Product / Specific Test Performed Test Method Specification Range of Testing /
Material of Test against which tests are Limits of Detection
performed

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 %

18. 4-(Dimethyl Appearance FPTO-001 (w.e.f. 25.11.14) Qualitative


amino) pyridine
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 BP 2016 (Appendix IIA) Qualitative


19. 2-Aminopyridine Appearance FPTO-001(w.e.f. 25.11.14) Qualitative

Solubility USP 38, Page. 994 Qualitative

Identification by GC FPTO-056 Qualitative


(w.e.f.01.10.13)

Identification by IR BP 2016 Qualitative


(Appendix IIA)

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 %

Rini Narayan N. Venkateswaran


Convenor Program Manager
Laboratory Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,
Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard ISO/IEC 17025: 2005

Discipline Chemical Testing Issue Date 23.04.2016


Certificate Number T-1752 Valid Until 22.04.2018
Last Amended on - Page 8 of 16
S. No. Product / Specific Test Performed Test Method Specification Range of Testing /
Material of Test against which tests are Limits of Detection
performed

20. Piperidine 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 FPTO-059 (w.e.f.01.10.13) 0.0025 % to 1.0 %


21. Picolinic acid Appearance USP 38 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 80.0 % to 100 %


(w.e.f. 01.10.13)

22. 2-Amino-4- Appearance FPTO-001(w.e.f. 25.11.14) Qualitative


Methyl pyridine
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 %

Rini Narayan N. Venkateswaran


Convenor Program Manager
Laboratory Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,
Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard ISO/IEC 17025: 2005

Discipline Chemical Testing Issue Date 23.04.2016


Certificate Number T-1752 Valid Until 22.04.2018
Last Amended on - Page 9 of 16
S. No. Product / Specific Test Performed Test Method Specification Range of Testing /
Material of Test against which tests are Limits of Detection
performed

23. 2-Amino-5- Appearance FPTO-001(w.e.f. 25.11.14) Qualitative


Methyl pyridine
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

2-Amino-5- Identification by GC FPTO-074 (w.e.f.01.10.13) Qualitative


Methyl pyridine
Identification by IR BP 2016(Appendix II A) Qualitative

24. 2-Amino-6- Appearance FPTO-001(w.e.f. 25.11.14) Qualitative


Methyl Pyridine
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 %

25. 3-Acetyl Pyridine 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 %

Rini Narayan N. Venkateswaran


Convenor Program Manager
Laboratory Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,
Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard ISO/IEC 17025: 2005

Discipline Chemical Testing Issue Date 23.04.2016


Certificate Number T-1752 Valid Until 22.04.2018
Last Amended on - Page 10 of 16
S. No. Product / Specific Test Performed Test Method Specification Range of Testing /
Material of Test against which tests are Limits of Detection
performed

26. 3,5-Dimethyl Appearance FPTO-001(w.e.f. 25.11.14) Qualitative


Piperidine
Water Content IS 2362: 1993 (RA 2010) 0.005 % to 2.0 %

Specific Gravity IP 2014, Page. 208 0.70 to 1.0

Purity FPTO-060 (w.e.f.18.06.15) 98.00 -100 %


3,5-Dimethyl A) Cis Isomer FPTO-060 (w.e.f.18.06.15) 70.0 % to 95.0 %
Piperidine
B) Trans Isomer FPTO-060 (w.e.f.18.06.15) 5 % to 30 %

27. 3-(Amino methyl) Appearance FPTO-001 (w.e.f. 25.11.14) Qualitative


pyridine
Moisture IS 2362: 1993 (RA 2010) 0.005 % to 2.0 %

Purity FPTO-120 (w.e.f.19.11.13) 98.00 -100 %

28. 3-Pyridyl acetic Description FPTO-001 (w.e.f. 25.11.14) Qualitative


acid
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 %

29. 2-(Amino methyl) Appearance FPTO-001(w.e.f. 25.11.14) Qualitative


pyridine
Moisture IS 2362: 1993 (RA 2010) 0.0010 % to 2.0 %

Purity FPTO-159 (w.e.f.01.10.13) 98.00 -100 %

30. 2,3,5 Collidine Appearance FPTO-001(w.e.f. 25.11.14) Qualitative

Rini Narayan N. Venkateswaran


Convenor Program Manager
Laboratory Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,
Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard ISO/IEC 17025: 2005

Discipline Chemical Testing Issue Date 23.04.2016


Certificate Number T-1752 Valid Until 22.04.2018
Last Amended on - Page 11 of 16
S. No. Product / Specific Test Performed Test Method Specification Range of Testing /
Material of Test against which tests are Limits of Detection
performed

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 IP 2014, Page. 203 1.32 % to 1.70


31. 5-Methyl Appearance FPTO-001(w.e.f. 25.11.14) Qualitative
Nicotinic Acid
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 %

32. Cetyl pyridinium Appearance FPTO-001(w.e.f. 25.11.14) Qualitative


Chloride
Monohydrate 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%

Rini Narayan N. Venkateswaran


Convenor Program Manager
Laboratory Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,
Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard ISO/IEC 17025: 2005

Discipline Chemical Testing Issue Date 23.04.2016


Certificate Number T-1752 Valid Until 22.04.2018
Last Amended on - Page 12 of 16
S. No. Product / Specific Test Performed Test Method Specification Range of Testing /
Material of Test against which tests are Limits of Detection
performed

Heavy Metals USP 38, Method II <231> Qualitative


Cetyl pyridinium Residue On Ignition IP 2014, Page. 163 0.010 % to 5.0 %
Chloride
Monohydrate Acidity USP 38 Qualitative
(Pass / Fail)

Assay USP 38 80.0 % to 102 %

Appearance of 1% Solution in Ph.Eur 7.0, Page. 1838 Qualitative


Water

Appearance of 40% Soln in PEG FPTO-268 (w.e.f.25.11.14) Qualitative

33. 2,4 6 Collidine 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

34. 2,3-Lutidine 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 %

35. 2,4-Lutidine 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 %

36. 2,5-Lutidine Appearance Visual (FPTO-001) Qualitative


(w.e.f. 25.11.14)

2,5-Lutidine Water Content IS 2362: 1993 (RA 2010) 0.0050 % to 2.0 %

Rini Narayan N. Venkateswaran


Convenor Program Manager
Laboratory Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,
Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard ISO/IEC 17025: 2005

Discipline Chemical Testing Issue Date 23.04.2016


Certificate Number T-1752 Valid Until 22.04.2018
Last Amended on - Page 13 of 16
S. No. Product / Specific Test Performed Test Method Specification Range of Testing /
Material of Test against which tests are Limits of Detection
performed

Purity FPTO-073 (w.e.f.01.10.13) 98.00 -100 %

Specific Gravity IP 2014, Page: 208 0.80 to 1.0

37. 2,6 Lutidine 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)

38. 3,4 Lutidine 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

39. 3,5-Lutidine 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 %

40. 2,3,5- Appearance FPTO-001(w.e.f. 25.11.14) Qualitative


Trichloropyridine
Water Content IS 2362: 1993 (RA 2010) 0.0010 % to 2.0 %

Rini Narayan N. Venkateswaran


Convenor Program Manager
Laboratory Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,
Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard ISO/IEC 17025: 2005

Discipline Chemical Testing Issue Date 23.04.2016


Certificate Number T-1752 Valid Until 22.04.2018
Last Amended on - Page 14 of 16
S. No. Product / Specific Test Performed Test Method Specification Range of Testing /
Material of Test against which tests are Limits of Detection
performed

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 %

41. 2-Pyridine Appearance FPTO-001(w.e.f. 25.11.14) Qualitative


Carboxaldehyde
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 FPTO-161 (w.e.f.01.10.13) 98.00 % to 100 %


2-Pyridine Assay FPTO-222 80.0 % to 102 %
Carboxaldehyde (w.e.f.01.10.13)

42. Azacyclonol Appearance FPTO-001(w.e.f. 25.11.14) Qualitative

Identification(by IR) BP 2016(Appendix II A) Qualitative

Rini Narayan N. Venkateswaran


Convenor Program Manager
Laboratory Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,
Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard ISO/IEC 17025: 2005

Discipline Chemical Testing Issue Date 23.04.2016


Certificate Number T-1752 Valid Until 22.04.2018
Last Amended on - Page 15 of 16
S. No. Product / Specific Test Performed Test Method Specification Range of Testing /
Material of Test against which tests are Limits of Detection
performed

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 %

Residual Solvent

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 %

43. 5-Chloro-2,3- Appearance FPTO-001(w.e.f. 25.11.14) Qualitative


Difluoro Pyridine
(CDFP) Identification FPTO-272 Qualitative
(w.e.f. 01.10.13)

Chromatographic Purity FPTO-272 2 % to 100 %


(w.e.f. 01.10.13)

Organic Byproducts

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 FPTO-272 0.01 % to 1.0 %


Products (w.e.f. 01.10.13) (1.0 %)
5-Chloro-2,3- Solvent as Methyl Benzene FPTO-272 0.05 % to 10.0 %
Difluoro Pyridine (w.e.f. 01.10.13)
(CDFP)
Additives Contents Of Fluoride FPTO-273 0.0005 % to 0.10 %
(w.e.f. 01.10.13)

-X-X-X-X-X-X-X-X-X-X-X-X-X-X-

ABBREVIATIONS:

Rini Narayan N. Venkateswaran


Convenor Program Manager
Laboratory Quality Control Laboratory, Jubilant Life Sciences Ltd., Bhartiagram,
Gajraula, Dist. Amroha, Uttar Pradesh

Accreditation Standard ISO/IEC 17025: 2005

Discipline Chemical Testing Issue Date 23.04.2016


Certificate Number T-1752 Valid Until 22.04.2018
Last Amended on - Page 16 of 16
S. No. Product / Specific Test Performed Test Method Specification Range of Testing /
Material of Test against which tests are Limits of Detection
performed

S. No. Short Form Full Form


1 FPTO Finish Product Test method Organic intermediate
2 IND-SU-WAD Customer Method (PepsiCo India)
3 ISBT International Society of Beverage Technologists
4 QC/FPTM Quality Control/ Finish Product Test Method
5 Ph.Eur European Pharmacopoeia
6 RMTO Raw Material test method Organic intermediate
7 NA Not Applicable
8 w.e.f With effective from

Rini Narayan N. Venkateswaran


Convenor Program Manager

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