Transcription of Annex 2 Stability testing of active pharmaceutical ...
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Annex 2 Stability testing of active pharmaceutical ...
87 World Health OrganizationWHO Technical Report Series, No. 953, 2009 Annex 2 Stability testing of active pharmaceutical ingredients and fi nished pharmaceutical products1. Introduction Objectives of these guidelines Scope of these guidelines General principles2. Guidelines active pharmaceutical ingredient .. General Stress testing Selection of batches Container closure system Specifi cation testing frequency Storage Stability commitment Evaluation Statements and labelling Ongoing Stability studies Finished pharmaceutical product
89 2. Guidelines 2.1 Active pharmaceutical ingredient 2.1.1 General Information on the stability of the API is an integral part of the systematic approach to stability evaluation. Potential attributes to be tested on an API
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