Type of Posting Notice of Intent to Revise
Posting Date 22–Feb–2019
Targeted Official Date To Be Determined
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 Monographs – Chemical Medicines 4 Expert Committee intends to revise the Alprazolam Tablets monograph.
Comments with supporting data were received that indicate the relative response factors in the test for Organic Impurities are not suitable. In response, a Revision Bulletin was posted to postpone the test for Organic Impurities within the Alprazolam Tablets monograph. The Expert Committee proposes to revise the Alprazolam Tablets monograph to revise the relative response factors and/or to replace the use of one or more relative response factors with the use of external standards in the test for Organic Impurities.
It is anticipated that the proposed revision will be published as an Interim Revision Announcement (IRA) in a future issue of Pharmacopeial Forum.
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