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Validation of Analytical Methods

Guidance DocumentValidation of Analytical Methods Document IDIPC/GD/04 Version Date 16th September 2021 Indian Pharmacopoeia CommissionMinistry of Health & Family Welfare, Government of IndiaSector 23, Raj Nagar, Ghaziabad 201 002E-mail: Web: | 2 DisclaimerThis Guidance Document is compiled by the Indian Pharmacopoeia Commission (IPC) after consultations with the Core Expert Committee constituted by the IPC for this purpose. The information contained herein represents the current best practices in the field of pharmacopoeial sciences to demonstrate compliance with the existing regulatory requirements.

Method validation is the process by which it is demonstrated through documentary evidence that the performance characteristics of the method meet the requirements for the intended ... Related SubstancesFive levels, LOQ to acceptance criteria % y intercept NMT 5.0%, R≥0.99

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Validation of Analytical Methods

ipc.gov.in

Method 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 ...

  Methods, Validation, Related, Substance, Method validation

Guidance Document for Marketing Authorization Holders

ipc.gov.in

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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5.11. Nitrosamine Impurities

ipc.gov.in

dimethylamine [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.

  Methylpyrrolidone

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