DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)finished product has been tested for microcystin-LR using an acceptablemethod;ii) For products containing Red Yeast Rice (Monascus purpureus),applicants shall provide certificates of analysis (for both raw material andfinished product) showing the Monacolin-K content. The Monacolin-Kconsumed shall not exceed 10 mg per day.2.5.4 LIMIT TEST FOR HEAVY METALSLimit for heavy metals:i) Lead : NMT 10.0 mg/kg or 10.0 mg/litre (10.0ppm)ii) Arsenic : NMT 5.0 mg/kg or 5.0 mg/litre (5.0ppm)iii) Mercury : NMT 0.5 mg/kg or 0.5 mg/litre (0.5ppm)iv) Cadmium : NMT 0.3 mg/kg or 0.3 mg/litre (0.3ppm)2.5.5 DISINTEGRATION TESTDisintegration time for tablets, capsules and pillsi) Uncoated tablets : NMT30 minutesii) Film-coated tablets : NMT 30 minutesiii) Sugar-coated tablets : NMT 60 minutesiv)Enteric-coatedtablets: Does not disintegrate for 120 minutes in acidsolution but to disintegrate within 60 minutes inbuffer solutionv) Capsules : NMT 30 minutesvi) Pills : NMT 120 minutesNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 272
Drug Registration Guidance Document (<strong>DRGD</strong>)2.5.6 TEST FOR UNIFORMITY OF WEIGHT (FOR TABLETS ANDCAPSULES ONLY)i) Tablet- For tablet with average weight of 130mg or less: Not more than 2tablets differ from the average weight by more than 10% AND notablets differ from the average weight by more than 20%- For tablet with average weight between 130-324mg: Not more than 2tablets differ from the average weight by more than 7.5% AND notablet differs from the average weights by more than 15%- For tablets with average weight more than 324mg: Not more than 2tablets differ from the average weight by more than 5% AND no tabletdiffers from the average weight by more than 10%ii) CapsuleIndividual weight of the capsule to be within the limit of 90 - 110% ofthe average weight.2.5.7 TESTS FOR MICROBIAL CONTAMINATIONTABLE 8:Route of AdministrationTAMC(CFU/g or CFU/ml)TYMC(CFU/g or CFU/ml)Test for SpecifiedMicroorganismsRectal Use NMT 2 x 10 3 NMT 2 x 10 2Oromucosal UseGingival UseCutaneous UseNasal UseAuricular UseNMT 2 x 10 2 NMT 2 x 10 1 - Absence of Staphylococcusaureus in 1g or 1ml- Absence of Pseudomonasaeruginosa in 1g or 1mlNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 273
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ATTACHMENT 1Drug Registration Guida
Page 222 and 223: Drug Registration Guidance Document
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
Page 230 and 231: ATTACHMENT 2Drug Registration Guida
Page 236 and 237: APPENDIX 5:Drug Registration Guidan
Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
Page 274 and 275: Route of AdministrationTAMC(CFU/g o
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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