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Clidinium Bromide

Type of Posting: Revision Bulletin

Posting Date: 30–Sept–2010

Official Date: 01–Oct–2010

Expert Committee: Monographs—Small Molecules 3

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee (SM3) has revised the Clidinium Bromide monograph as follows.

Organic impurities. The purpose of this revision is to eliminate the use of USP 3-Quinuclidinyl Benzilate RS under Organic impurities. USP 3-Quinuclidinyl Benzilate RS is an incapacitating nerve agent, also known as "BZ", Agent 15, or Agent 78. This compound is specifically listed on the United States Munitions List (USML) and in the Chemical Weapons Convention (CWC), Schedule 2, therefore it is controlled by the U.S. State Department and classified as a chemical weapon. This material cannot be shipped outside of the U.S. by USP and it is also of considerable danger to the user and to USP collaborative labs. Considering these restrictions and the risk associated with handling this material, USP has made a decision to discontinue this Reference Standard.

Identification. To address a safety concern associated with the use of picrates, the current test for Identification-B has been replaced with the agreement of RF values of the principal spot of the Sample solution and the Standard solution, as obtained in the Organic impurities.

This Clidinium Bromide Revision Bulletin supersedes the currently official Clidinium Bromide monograph. The Revision Bulletin will be incorporated in the First Supplement to USP 34–NF 29.

Should you have any questions, please contact Elena Gonikberg, Ph.D. (301-816-8251 or eg@usp.org).