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.
Working document QAS/17.694 page 3 Introduction and background36 37 38 The Stability testing of active pharmaceutical ingredients and finished 39 pharmaceutical products was published as Annex 2 in the WHO Technical 40 Report Series, No. 953, 2009 (1). 41 42 These regulatory guidelines seek to exemplify the core stability data package 43 required for registration of …
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