Inhalation Saturday, May 25, 2013
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Critical evaluation of the revised and new USP chapters for aerosols: <601> and <5> [Pharm Forum 2011; 37(4)]

This is the first of two articles, to be published by Inhalation, presenting opinions from representatives of IPAC-RS on the proposed new and revised USP Chapters for Aerosols <601> and <5>.

In July 2011, Pharmacopeial Forum published an in-process revision of Chapter <601>, under a changed title "Product Performance Tests—Nasal and Inhalation Aerosols, Sprays, And Powders," with significantly revised content and with a new companion Chapter <5>, entitled "Inhalation and Nasal Drug Products—General Information and Product Quality Tests." Accordingly, the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS)3 submitted comments on the proposed revised Chapter <601> and new Chapter <5>. The remainder of this article highlights some of the problematic changes proposed by the USP.



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