Type of Posting: Notice of Intent to Revise
Posting Date: 16-Dec-2022
Targeted Official Date: 01-Sept-2023; Interim Revision Announcement
Expert Committee: Small Molecules 2
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 2 Expert Committee intends to revise the Phenoxybenzamine Hydrochloride monograph.
Comments with supporting data were received which indicate that phenoxybenzamine aziridinium can be formed in-situ under the chromatographic conditions of the Organic Impurities test. The Expert Committee proposes to revise the Organic Impurities test to clarify that phenoxybenzamine aziridinium is not regarded or controlled as an impurity of phenoxybenzamine hydrochloride.
Additional changes to align the monograph with current USP style are also proposed.
It is anticipated that the proposed revisions will be published as an Interim Revision Announcement (IRA) in Pharmacopeial Forum 49(2) [Mar–Apr. 2023] pursuant to the Rules and Procedures. The comment period for this revision would end on May 31, 2023. In the absence of any adverse comments, the proposed IRA would become official on September 1, 2023.
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