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Type of Posting: Notice of Intent to Revise

Posting Date: 26–Feb–2016

Targeted Official Date: Interim Revision Announcement, 01–Nov–2016

Expert Committee: Chemical Medicines Monographs 4

In accordance with section 7.04(c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that the Chemical Medicines Monographs 4 Expert Committee intends to revise the Pimozide monograph which appears in USP 39–NF 34.

Based on the comments received, the Expert Committee proposes to add a process impurity with acceptance criteria. In addition, the Identification A test, based on the Infrared absorption, is revised to allow more flexibility to the users.

It is anticipated that the proposed revision will be published as a proposed Interim Revision Announcement (IRA) in Pharmacopeial Forum 42(3) [May–Jun. 2016] pursuant to section 7.02 of the Rules and Procedures. The comment period for this revision ends on July 31, 2016. In the absence of any adverse comments the proposed IRA will become official on November 1, 2016.

Should you have questions, please contact K. Kalyana Seela, Senior Scientific Liaison to the Chemical Medicines Monographs 4 Expert Committee at