Type of Posting: General Announcement
Posting Date: 30–Nov–2012
Official Date: 01–Dec–2012
Archive Date: 09–Feb–2015
Expert Committee: Monographs—Small Molecules 4
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Ziprasidone Hydrochloride monograph. The purpose of the revision is to accommodate the sponsors’ FDA-approved specifications as follows:
- The anhydrous form of the drug substance is added to the monograph:
- The chemical information section is revised to delete the term “monohydrate” from the chemical names, and to add the molecular formula, molecular weight, and CAS number for the anhydrous form
- A procedure for polymorphic equalization is added under Identification Test A
- The calculations under Limit of Early-Eluting Impurities and Limit of Late-Eluting Impurities are revised to accommodate both the monohydrate and anhydrous forms
- The test for Water Determination is revised to add a limit of NMT 2.0% for the anhydrous form, and the Labeling statement is added
- The following additional changes are also made to accommodate the sponsors’ FDA-approved specifications and to provide clarifications:
- The Assay acceptance criteria in the Definition are widened from “98.0%–102.0%” to “97.5%–102.0%”
- The limit for Residue on Ignition is widened from NMT 0.1% to NMT 0.2%
- Under Identification Test C, the instructions for the preparation of the Sample solution are added
- A note is added to indicate when to perform the test for Limit of Tetrahydrofuran under Organic Impurities
The Ziprasidone Hydrochloride Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the Second Supplement to the USP 36–NF 31.
Should you have any questions, please contact Mary P. Koleck, Ph.D. (301-230-7420 or mpk@usp.org).