DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)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