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

  • Publication Date: 02/01/2012
  • Author(s):
    Leiner, Stefan Schumacher, Jackie
  • Organization(s):
    International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS)
  • Article Type: Technical Articles
  • Subjects: Device Design, Industry Issues and Trends, Product Development/Formulation, Testing, Validation, and Regulatory Compliance
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 , under a changed title “Product Performance Tests—Nasal and Inhalation Aerosols, Sprays, And Powders,” with
significantly revised content and with a new companion Chapter , 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 and new Chapter . The remainder of this article highlights some of the problematic changes proposed by the USP.

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