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〈701〉 Disintegration

BRIEFING

〈701〉 Disintegration. This proposal is based on the version of the chapter official as of May 1, 2020. The European Pharmacopoeia is the coordinating pharmacopeia for the international harmonization of the compendial standards for the Disintegration general chapter, as part of the process of international harmonization of monographs and general analytical methods of the European, Japanese, and United States pharmacopeias. The following general chapter, which represents the OFFICIAL INQUIRY STAGE 2A of Revision 5 (version 1) to the Pharmacopeial Discussion Group (PDG) harmonized document, includes changes in the following sections:

  1. Introduction.

  2. Apparatus: clarified Test A Basket-Rack Assembly and inclusion of the Test B Basket-Rack Assembly.

 Additionally, minor editorial changes have been made to update the chapter to current USP style.

 (GCDF: M. Marques)

 Correspondence Number—C324216

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