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Guidance Document for Marketing Authorization Holders
Marketing Authorization Holders of Pharmaceutical Products Published by Indian Pharmacopoeia Commission National Coordination Centre - Pharmacovigilance Programme of India ... migM or—te completed frials and individual gas. have Imblinded for saf$-related (e. , expedited if applicable. and/or should not
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Validation of Analytical Methods
ipc.gov.inMethod validation is the process by which it is demonstrated through documentary evidence ... Related SubstancesFive levels, LOQ to acceptance criteria % y intercept NMT 5.0%, R≥0.99 ... The reported limits for accuracy for drug substances and products are 98.0-102.0% and 97.0-103.0% respectively. For the impurity determination, range from 50 ...
5.11. Nitrosamine Impurities
ipc.gov.indimethylamine [DMA], triethylamine[TEA], N-methylpyrrolidone [NMP]) in the presence of nitrites and acid media. Use of recycled solvents that may contain nitrosamine or their precursors. Use of sanitized water (e.g., chloramines) Insufficient purification.
Validation of Analytical Methods
ipc.gov.incriteria for all other instrumental test method validation. Typical method validation protocol ... Analytical Performance Characteristics (i) Specificity Specificity (or selectivity) of the analytical method is defined as the ability to assess ... value accepted either as a conventional true value or an accepted reference value and the
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