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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.
Working document QAS/17.694 page 5 102 Stability testing of active pharmaceutical ingredients and 103 finished pharmaceutical products 104 1. Introduction 1.1 Objectives of these guidelines105 106 1.2 Scope of these guidelines 107 1.3 General principles 108 2. Guidelines 109 2.1 Active pharmaceutical ingredient 2.1.1 General110 2.1.2 Stress testing111 112 2.1.3 Selection of batches
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