Bureau of Laboratory Quality Standards. This is to certify that. The laboratory BUREAU OF DRUG AND NARCOTIC, DEPARTMENT OF MEDICAL SCIENCES

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1 Bureau of Laboratory Quality Standards Ministry of Public Health This is to certify that The laboratory of BUREAU OF DRUG AND NARCOTIC, DEPARTMENT OF MEDICAL SCIENCES 88/7 Moo 4, Soi Bumrasnaradura Hospital, Tiwanon Rd., Talad-Khwan District, Amphur Muang, Nonthaburi 11000, Thailand has been accepted as an accredited laboratory complying with the ISOIIEC : 2005 and the requirements of the Bureau of Laboratory Quality Standards The laboratory has been accredited for specific tests listed in the scope within the field of Drug and Narcotics Testing ~~(t.t (Mrs. Chomchailai JJL Sinthusarn) Director of Bureau of Laboratory Quality Standards Date of Accreditation

2 I Tablets and Capsules 1. Assay for Active Ingredients 1. Current USP / NF <621>. 2. Active Pharmaceutical 2. Current BP <Appendix IIID> Ingredients for Reference Substances Production and Active Pharmaceutical by High Performance Liquid Chromatography (HPLC) Technique. Ingredients 3. Tablets and Capsules 2. Dissolution 1. Current USP / NF <711>. 2. Current BP <Appendix XIIB>. by Dissolution, Spectrophotometry Technique.,4. Active Pharmaceutical 3. Identification 1. Current USP / NF <197>. Ingredients for 2. Current BP <Appendix II A>. Reference Substances Production and Active Pharmaceutical Ingredients by Infrared Spectrophotometry Technique. 4. Melting Range 1. Current USP / NF <741>. 2. Current BP <Appendix VA>. I by Differential Scanning Calorimetry, Melting Point Determination Technique. ~";Ji Bureeu of LaboratoryQualityStandards Page 1 of 12 Date Revised

3 4. Active Pharmaceutical 5. ph 1. Current USP / NF <791>. Ingredients for Reference Substances Production and Active Pharmaceutical Ingredients (continued) 2. Current BP <Appendix VL>. by ph Determination Technique. 6. Specific Optical Rotation 1. Current USP / NF <781>. 2. Current BP <Appendix VF>. by Optical Rotation Technique. 7. Degradation Product, 1. Current USP / NF <621>. Related Substances, 2. Current BP <Appendix 1110> Chromatographic Purity by Chromatography Technique 8. Water Content 1. Current USP / NF <921>, 9. Loss on Drying <731>. 2. Current BP <Appendix IX C, IX 0>. by Karl Fisher Titration and Oven Technique. 10. Assay for Active Ingredients 1. Current USP / NF (Chemical) <621>,<851 >,<541>. 2. Current BP <Appendix 1110, III A, II B, VIII B>. by Chromatography, Spectrophotometry and Titration Technique. ~i;' Bureau of Laboratory Quality Standards Page 2 of 12 Date Revised

4 5. Traditional Medicines * 11. Identification of In-house Method SOP Dexamethasone use by Thin Layer Chromatography I Prednisolone -- (TLC) Technique. 12. Identification of TP Supplement 2005 by - Clostridium spp. Enrichment Method. - Staphylococcus aureus - Salmonella spp. j 6. Injection 13. Kinetic Turbidity of Current USP / NF <85>. by Kinetic i Bacterial Endotoxins Turbidity Method. --- Bureau of LaboratoryQualityStandards Page 3 of 12 Date Revised

5 7. Non-sterile 14. Microbiological Examination Pharmaceutical of Non-sterile Products Products - Total Aerobic Microbial Count 1. BP 2013, Appendix XVI B Microbiological Examination of - Total Combined Yeasts and Non-sterile Products. Moulds Count 2. USP 36 / NF 31: Chapter <61> Microbiological Examination of Non-sterile Products: Microbial Enumeration Tests. 3. TP Supplement 2010, 10.2 Microbial Limit Tests. by Plate count Technique. ~" Bureau of Laboratory Quality Standards Page 4 of 12 Revision No. 00 Date of Accreditation Date Revised

6 7. Non-sterile 14. Microbiological 1. BP 2013, Appendix XVI B Pharmaceutical Examination of Non-sterile Microbiological Examination of Products Products Non-sterile Products. (continued) - Bile-tolerance Gram 2. USP 36 / NF 31: Negative Bacteria (Test for Absence and Quantitative Test) - Escherichia coli - Salmonella spp. Chapter <62> Microbiological of Non-sterile Products: Tests for Specified Microorganisms. 3. TP Supplement 2010, 10.2 Microbial Limit Tests. - Clostridium spp. by Enrichment and Probable Number Technique. tkjti~ Bureau of Laboratory Quality Standards Page 5 of 12 Revision No. 00 Date Revised Date of Accreditation

7 8. Sterile Pharmaceutical 15. Sterility Test Products 8.1 Powder for Injection 8.2 Liquid Injection 1. BP 2013, Appendix XVI A. Test for Sterility. 2. USP 36 1 NF 31: Chapter 8.3 Large Volume <71> Sterility Test. Parenterals (LVP) 8.4 Dialysis Solution by Membrane Filtration Technique. 8.5 Sterile Ophthalmic solution 8.6 Sterile Solution for Contact Lens 8.7 Sterile Suspension for Injection 8.8 Sterile Ophthalmic Suspension 8.9 Ophthalmic Ointment 1. BP 2013, Appendix XVI A. Test for Sterility. 2. USP 36 1 NF 31: Chapter <71> Sterility Test. by Direct Inoculation Technique. and Ophthalmic Gel ~~drlt Bureau of Laboratory Quality Standards Page 6 of 12 Date Revised

8 9. Plastic Bead Type 16. In vitro Biological Reactivity Current USP / NF <87>. by Elution PVC, PP, PE for Test Test Method. Medical Devices and Plastic Container for Pharmaceutical Preparation 10. Plastic Containers for 17. Permeability to TIS (2003). Plastics Sterile Pharmaceutical Microorganisms containers for sterile Products pharmaceutical products. Page by Permeability to Microorganisms Technique. 11. Medical Devices 18. Kinetic Turbidity of Bacterial Current USP / NF <85>. by Kinetic Endotoxins Turbidity Method. 19. In vitro Cytotoxicity Test ISO : 2009 by Test on I I Extract Method. W~~ Bureauof LaboratoryQualityStandards Page 7 of 12 Revision No. 00 Date Revised Date of Accreditation

9 12. Narcotics (Powder) 20. Identification of Heroin In-house Method SOP by Hydrochloride Color Test and Thin Layer Chromatography in Connection with: 1. United Nations, Recommended Methods for Testing Amphetamine and Methamphetamine, Manual for Use by National Narcotics Laboratories, I New York: United Nations, Moffat A.C., Osselton M.D. and Widdop B. Clark's Analysis of Drugs and Poisons in Pharmaceuticals, Body Fluids and Postmortem Material. rd 3 ed., London-Chicago: The Pharmaceutical Press, _ (jft$j,k~' Bureau of Laboratory Quality Standards Page 8 of 12 AccreditationNumber 4044/50 Date Revised

10 13. Narcotics 21. Identification of In-house Method SOP (Tablets and Powder) Methamphetamine by Color Test and Thin Layer Hydrochloride Chromatography in Connection with: 1. United Nations, Recommended Methods for Testing Amphetamine and Methamphetamine, Manual for Use by National Narcotics Laboratories, New York: United Nations, Moffat A.C., Osselton M.D. and Widdop B. Clark's Analysis of Drugs and Poisons in Pharmaceuticals, Body Fluids and Postmortem Material. rd 3 ed., London-Chicago: The Pharmaceutical Press, Quantitative Analysis of In-house Method SOP by Methamphetamine Gas Chromatography Technique. Hydrochloride 14. Plants 23. Qualitative Analysis of In-house Method SOP by Cannabinoils in Seized Material Color Test and Thin Layer Chromatography Technique.!frl1J1tYt/J,I Bureau of Laboratory Quality Standards Page 9 of 12 Date Revised

11 I 15. Urine 24. Screening Test In-house Method SOP Methamphatamine Immunology by Rapid Test Kit - Morphine Technique. - Cannabinoils I - Benzodiazepine - Cocaine - MDMA Group - Ketamine 25. Qualitative and Quantitative In-house Method SOP Analysis of Amphetamines by Gas Chromatography Mass Group Spectrometry and SOP by Liquid Chromatography Mass Spectrometry Technique. 26. Qualitative and Quantitative In-house Method SOP Analysis of Morphine by Gas Chromatography Mass Spectrometry Technique. 27. Qualitative and Quantitative In-house Method SOP Analysis of Cannabinoils by Gas Chromatography Mass Spectrometry Technique. I 28. Qualitative and Quantitative In-house Method SOP Analysis of MDMA Group by Liquid Chromatography Mass Spectrometry Technique. 1A""tt/~; Bureau of Laboratory Quality Standards Page 10 of 12 Date Revised

12 15. Urine 29. Identification of In-house Method SOP (continued) Methamphetamine by Immunoassay Techniques and Thin Layer Chromatography in Connection with: 1. United Nations, Recommended Methods for the Detection and Assay of Heroin, Cannabinoids, Methamphetamine and Ring- Substituted Amphetamine Derivatives in Biological I Specimens, Manual for Use by National Laboratories: United Nations, New York, Moffat A.C., Osselton M.D. and Widdop B. Clark's Analysis of Drugs and Poisons in Pharmaceuticals, Body Fluids. rd and Postmortem Material, 3 London-Chicago: The Pharmaceutical Press, ed., ;tin,!lai/a, Bureau of Laboratory Quality Standards Page 11 of 12 Date Revised

13 Remark:- * Traditional Medicines are as mentioned in the ASEAN AGREEMENT ON TRADITIONAL MEDICINES mean any medicinal product for human use consisting of active ingredients derived from natural sources (plants, animals and/or minerals) used in the system of traditional practice. It shall not include any sterile preparation, vaccines, any substance derived from human parts, any isolated and characterized chemical substances. rj~d/i{/~/ Bureau of Laboratory Quality Standards Page 12 of 12 AccreditationNumber 4044/50 Date Revised