Transcription of STABILITY TESTING OF ACTIVE SUBSTANCES AND …
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STABILITY TESTING OF ACTIVE SUBSTANCES AND …
Working document RESTRICTED STABILITY TESTING OF ACTIVE SUBSTANCES AND PHARMACEUTICAL PRODUCTS _____ World Health Organization 2006 All rights reserved. This draft is intended for a restricted audience only, the individuals and organizations having received this draft. The draft may not be reviewed, abstracted, quoted, reproduced, transmitted, distributed, translated or adapted, in part or in whole, in any form or by any means outside these individuals and organizations (including the organizations concerned staff and member organizations) without the permission of WHO.
The guideline addresses the information to be submitted in registration applications for New Chemical Entities as well as existing active substances and their related pharmaceutical products for human use. 1.3 General Principles The purpose of stability testing is to provide evidence on how the quality of an active
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