Transcription of STABILITY TESTING OF ACTIVE PHARMACEUTICAL …
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STABILITY TESTING OF ACTIVE PHARMACEUTICAL …
Working document January 2017. Draft document for comment 1 STABILITY TESTING OF ACTIVE . 2 PHARMACEUTICAL ingredients AND. 3 FINISHED PHARMACEUTICAL PRODUCTS. 4 (January 2017). 5 DRAFT FOR COMMENT. Should you have any comments on the attached text and the STABILITY conditions for WHO Member States (MS) by Region, appendixed to the previous version of this guidance ( ), please send these to: Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies Standards and Norms, World Health Organization, 1211 Geneva 27, Switzerland; email: fax: (+41 22) 791 4730.
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 …
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