ICH
© World Health Organization WHO Technical Report Series, No. 953, 2009 Annex 2 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products 1. Introduction 1.1 Objectives of these guidelines 1.2 Scope of these guidelines 1.3 General principles Guidelines 2.1 Active pharmaceutical ingredient ..................... 2.1.1 General 2.1.2 Stress testing 2.1.3 Selection of batches 2.1.4 Container closure system 2.1.5 Specification 2.1.6 Testing frequency 2.1.7 Storage conditions Morequality and meeting the same specification as that intended for marketing. In the case of conventional dosage forms with APIs that are known to be stable, data ... Less
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