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Trazodone Hydrochloride

Type of Posting: Revision Bulletin

Posting Date: 30–Jan–2015

Official Date: 01–Feb–2015; updated 27–Feb–2015*

Expert Committee: Monographs—Small Molecules 4

Reason for Revision: Safety

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Trazodone Hydrochloride monograph. The purpose for the revision is to remove USP Trazodone Hydrochloride RS from the Standard solution within the test for the Limit of Trazodone Related Compound F and Cyclophosphamide Related Compound A.

The intended purpose of the test is to quantify trazodone related compound F and cyclophosphamide related compound A. The Standard solution will continue to include the use of USP Trazodone Related Compound A RS and USP Cyclophosphamide Related Compound A RS to quantify the two genotoxic impurities. The inclusion of USP Trazodone Hydrochloride RS in the Standard solution does not serve any purpose. The presence of trazodone related compound F in the USP Trazodone Hydrochloride RS could potentially interfere with the ability to accurately quantify trazodone related compound F.

Additionally, minor editorial changes were made for clarity.

This Trazodone Hydrochloride Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the Second Supplement to USP 38–NF 33.

Should you have any questions, please contact Ravi Ravichandran, Ph.D. (301-816-8330,

*The Revision Bulletin for Trazodone Hydrochloride that was posted on January 30, 2015 had an error in the revision tagging in the USP Reference Standards <11> Section. USP Trazodone Related Compound C was incorrectly tagged as having an errata correction that was official December 1, 2014. This revision tagging should have been place next to the entry for USP Trazodone Related Compound D. A corrected version of the Revision Bulletin has been attached to this notice.