DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)vii) Specification or acceptance criteria.e) Photocopies or methods directly copied from pharmacopoeias shall not beaccepted. In cases where test methods are adopted from official pharmacopeia,details of specifics requirements should be submitted.f) All relevant data collected during chemical and microbiological testing such aschromatograms HPLC/ GC, test reports and formulae used for calculating shouldalso be submitted.g) All documents should be arranged and labeled accordingly.9.2 SPECIFIC REQUIREMENTSThe specific requirements for test methods are based on type of tests and dosageforms of product as stated in Table VIII below:Categories Type of Tests Specific RequirementsPhysical &PerformanceTestsPhysical test (friability,uniformity of weight,pH, etc)Disintegration testDissolution testSpecific method for the intended analysisSpecific method for related dosage formsa. Dissolution parameters should include:i) type of apparatusii) type and volume of dissolutionmediumiii) rotation rateiv) temperature of solutionv) sampling timeb. Complete formula for calculationespecially for extended and delayedrelease products.c. Method of analysis for example HPLC,UV, etc.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 89