This document is a certificate from the Quality Control Laboratory of Jubilant Life Sciences Ltd. in Gajraula, India. It certifies that the laboratory is accredited to ISO/IEC 17025:2005 to perform chemical testing. The laboratory is certified to test a variety of industrial and fine chemicals. The certificate lists the specific tests performed for each chemical, the test methods used, and the acceptable range of results.
This document is a certificate from the Quality Control Laboratory of Jubilant Life Sciences Ltd. in Gajraula, India. It certifies that the laboratory is accredited to ISO/IEC 17025:2005 to perform chemical testing. The laboratory is certified to test a variety of industrial and fine chemicals. The certificate lists the specific tests performed for each chemical, the test methods used, and the acceptable range of results.
This document is a certificate from the Quality Control Laboratory of Jubilant Life Sciences Ltd. in Gajraula, India. It certifies that the laboratory is accredited to ISO/IEC 17025:2005 to perform chemical testing. The laboratory is certified to test a variety of industrial and fine chemicals. The certificate lists the specific tests performed for each chemical, the test methods used, and the acceptable range of results.
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
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 %
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
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
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
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
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
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
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
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 %
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
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
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 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 %
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)
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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
S.No. Product / Material of Test Specific Test Performed Test Method Specification Against Which Tests Are Performed Range of Testing / Limits of Detection