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BACTERIAL ENDOTOXIN TEST
NPCB MOH e. Test methods • Describe how the test is performed in detail • Gel clot method: European Pharmacopeia 5.0, 2.6.14 Bacterial endotoxins, Gel clot technique (Method A and B) 1. Preparatory Testing i. Confirmation of labeled lysate sensitivity
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GUIDELINE FOR STABILITY DATA
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www.npra.gov.my90ml of Buffered NaCl Peptone Solution + ≤100 cfu S. aureus Enrichment: 90ml of Tryptone Soya Broth (TSB), 30 - 35ºC, 18 – 24hrs 10 ml Selective Agar: Mannitol Salt Agar (MSA) Subculture on 30 -35ºC, 18 – 72hrs ≤100 cfu Ps. aeruginosa Cetrimide Agar (CETA)
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Overview on ASEAN Guideline on PV Requirements
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APPENDIX 8: LIST OF PERMITTED, PROHIBITED AND …
www.npra.gov.my32. Menthol External Preparations >16% 33. Mestranol Oral Contraceptives 34. Methylene Blue Oral Preparations 35. Midazolam All oral preparations, except 7.5mg coated tablet 36. Morphine Cough Mixtures 37. Neomycin Oral Antidiarrhoeal, Vaginal Tablets, Topical Powders, Aerosols, Nasal Preparations 38. Noradrenaline Dental Preparations 39.
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