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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.

sample concentration over a given range. For HPLC methods, the linear relationship between detector response (peak area and height) and sample concentration is determined. The relationship can be demonstrated directly on drug substance by dilution of standard stock or by separate weighing of the sample components, using the proposed procedures.

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5.11. Nitrosamine Impurities

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ipc.gov.in

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