Type of Posting: Notice of Intent to Revise
Posting Date: 27-May-2022
Targeted Official Date: 01-Jan-2023; Interim Revision Announcement
Expert Committee: Small Molecules 4
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 4 Expert Committee intends to revise the Ziprasidone Hydrochloride monograph.
Comments were received requesting clarification as to the appropriate calculations and appropriate basis for reporting impurity results in the test for Organic Impurities. Based on supporting data, the Expert Committee proposes to revise the Analysis instructions to reflect that impurity results are to be reported relative to the content of ziprasidone free base.
It is anticipated that the proposed revisions will be published as an Interim Revision Announcement (IRA) in Pharmacopeial Forum 48(4) [Jul.-Aug. 2022] pursuant to the Rules and Procedures. The comment period for this revision ends on Sep. 30, 2022. In the absence of any adverse comments, the proposed IRA will become official on January 1, 2023.
Should you have any questions, please contact Nicholas Garito, Principal Scientist (email@example.com).