COIFA | Assessment Policy

API Department (Quality Assessment)

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Assessment policy CADIFA Guidance Impurities ANVISA Guidelines Other Guidelines Pharmacopoeias ANVISA links Other links FAQ History

SECTIONS

General 3.2.S.1.1 3.2.S.1.2 3.2.S.1.3 3.2.S.2.1 3.2.S.2.2 3.2.S.2.3 3.2.S.2.4 3.2.S.2.5 3.2.S.2.6 3.2.S.3.1 3.2.S.3.2 3.2.S.4.1 3.2.S.4.2 3.2.S.4.3 3.2.S.4.4 3.2.S.4.5 3.2.S.5 3.2.S.6 3.2.S.7.1 3.2.S.7.2 3.2.S.7.3

3.2.S.4.2 - Analytical Procedures

Analytical procedures used for release and stability studies should be provided.

Quick access

RDC 359 RDC 200 RDC 73 RDC 166 ICH Q2 ICH Q6A