Transcription of STABILITY TESTING OF ACTIVE PHARMACEUTICAL …
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STABILITY TESTING OF ACTIVE PHARMACEUTICAL …
Working document January 2017 Draft document for comment STABILITY TESTING OF ACTIVE 1 PHARMACEUTICAL INGREDIENTS AND 2 FINISHED PHARMACEUTICAL PRODUCTS 3 (January 2017) 4 DRAFT FOR COMMENT 5 6 World Health Organization 2017 7 All rights reserved. 8 This draft is intended for a restricted audience only, the individuals and organizations having received this draft. 9 The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in 10 part or in whole, in any form or by any means outside these individuals and organizations (including the 11 organizations' concerned staff and member organizations) without the permission of the World Health Organization. 12 The draft should not be displayed on any website. 13 Please send any request for permission to: 14 Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies Standards and Norms, Department of 15 Essential Medicines and Health Products, World Health Organization, CH-1211 Geneva 27, Switzerland.
125 2.2.4 Container closure system 126 2.2.5 Specification 127 2.2.6 Testing frequency 128 2.2.7 Storage conditions 129 2.2.8 Stability commitments 130 2.2.9 Evaluation 2.2.10 Statements and131 labelling 132 2.2.11 In-use and hold-time stability 133 2.2.12 Variations 2.2.13 Ongoing stability134 studies 3. Glossary 135 References 136 137 ...
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