Type of Posting: Revision Bulletin
Posting Date: 28–Sep–2012
Official Date: 01–Jan–2013
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 Citalopram Hydrobromide monograph.
The purpose for the revision is to eliminate the quantitative uses of USP Citalopram Related Compound C RS in Organic Impurities, Procedure 2. Recent evaluation of the current lot of USP Citalopram Related Compound C RS by USP scientific staff has determined that it not suitable for its quantitative compendial usage as described in USP 35–NF 30. The revision allows quantification of specified citalopram related compounds using USP Citalopram Hydrobromide RS in Organic Impurities, Procedure 2.
The Organic Impurities, Procedure 2 is revised as follows:
- The Standard solution is revised to contain USP Citalopram Hydrobromide RS only.
- A System suitability solution containing USP Citalopram Hydrobromide RS and citalopram related compound reference standards is added to support the system suitability requirements and for peak identification.
- Quantification of citalopram related compounds is performed using USP Citalopram Hydrobromide RS and appropriate relative response factors. The limits of the citalopram related compounds remain unchanged.
Additionally, the trivial and chemical names for impurities in Table 1 within Organic impurities, Procedure 1 are updated. The USP Reference Standards section is revised to correct the chemical information for USP Citalopram Related Compounds A, C, D, G, and H Reference Standards and to indicate that USP Citalopram Related Compound D RS may be available in either the hydrochloride or hydrobromide salt form. Several minor editorial changes have been made to update the monograph to the current USP style.
The Citalopram Hydrobromide Revision Bulletin supersedes the currently official USP 35 monograph with a delayed implementation date of January 1, 2013 (three months after the posting date). Once posted, the revised text in the Revision Bulletin may be implemented prior to the stated official date per section 3.10 of the USP–NF General Notices. The Revision Bulletin will be incorporated in First Supplement to USP 36–NF 30.
Should you have any questions, please contact Heather Joyce, Ph.D. (301-881-0666, x8442 or hrj@usp.org).