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.
164 applicable to stability testing for biologicals. 165 1.3 General principles166 167 The purpose of stability testing is to provide evidence of how the quality 168 of an API or FPP varies with time under the influence of a variety of 169 environmental …
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