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General Chapter <1092> The Dissolution Procedure: Development and Validation

Type of Posting: General Announcement

Posting Date: 22–Nov–2013

Expert Committee: General Chapters—Dosage Forms

The General Chapters—Dosage Forms Expert Committee is proposing to revise General Chapter <1092> The Dissolution Procedure:; Development and Validation. In addition to a reorganization of the existing content, the proposed revision will include additional information on:

  • Preliminary assessments needed before initiating procedure development,
  • Automation, and
  • Acceptance criteria and interpretation of results from a dissolution test.

A companion Stimuli article explains the rationale and content of this proposed revision.

General Chapter <1092> and the associated Stimuli article have been approved for publication in Pharmacopeial Forum 40(1) [Jan.–Feb. 2014]. Both are being presented in advance of publication of PF 40(1) to allow additional time for public review and comment. Comments will be accepted until March 31, 2014, the end of the comment period for Pharmacopeial Forum 40(1).

Should you have any questions or comments, please contact Will Brown, Senior Scientific Liaison, at (301-816-8380 or