Skip to main content

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules

Type of Posting: Revision Bulletin

Posting Date: 30–Sept–2010

Official Date: 01–Oct–2010

Expert Committee: Monographs—Small Molecules 4

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee (SM4) has revised the Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules monograph.

In the Organic Impurities section, the test for Limit of 3-Quinuclidinyl Benzilate is deleted, as this impurity is a known process impurity and not a degradation product, and is therefore controlled in the drug substance monograph. This revision eliminates the use of USP 3-Quinuclidinyl Benzilate RS in this monograph. 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.

This Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated into the First Supplement to USP 34–NF 29.

Should you have any questions, please contact Ravi Ravichandran, Ph.D. (301-816-8330 or rr@usp.org).