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.

and the pharmaceutical excipients, the dosage form and its composition, the manufacturing process, the nature of the container-closure system, and the properties of the packaging materials. Also, the stability of excipients that may contain or form reactive degradation products, have to be considered.

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  Pharmaceutical, Active, Container, Substance, Of active substances and

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