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 General Selection of batches Container closure system Specifi cation testing frequency Storage conditions Stability commitment Evaluation Statements and labelling In-use Stability

88 1. Introduction 1.1 Objectives of these guidelines These guidelines seek to exemplify the core stability data package required for registration of active pharmaceutical ingredients (APIs) and

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  Pharmaceutical, Testing, Active, Ingredients, Active pharmaceutical ingredients, Stability testing of active pharmaceutical, Stability

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