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REVISION OF METHOD OF ANALYSIS: 5.3 …

Working document February 2014 Draft for comment REVISION OF METHOD OF ANALYSIS: disintegration TEST FOR tablets AND CAPSULES (February 2014) DRAFT FOR COMMENT DRAFT FOR COMMENTS World Health Organization 2014 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 the World Health Organization. The draft should not be displayed on any web site. Please send any request for permission to: Dr Sabine Kopp, Group Lead, Medicines Quality Assurance, Technologies, Standards and Norms, Department of Essential Medicines and Health Products, World Health Organization, CH-1211 Geneva 27, Switzerland.

Working document QAS/14.572 page 3 4 Revision of method of Analysis: 5.3 Disintegration test for tablets and capsules 5 [Note from the Secretariat. 6 It is proposed to include a disintegration test for large tablets in the test for disintegration of tablets 7 and capsules. The proposed method is reproduced with permission from The …

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