Type of Posting: Notice of Intent to Revise
Posting Date: 25–Sept–2020
Targeted Official Date: 01–Aug–2022, USP–NF 2022, Issue 2
Expert Committee: Small Molecules 5
In accordance with section 9.04 (c) of the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 5 Expert Committee intends to revise the Diphenhydramine Hydrochloride Oral Powder monograph.
The Expert Committee proposes to widen the limit for the degradant, Benzophenone, from 0.2% to 0.4% in the Diphenhydramine Hydrochloride Oral Powder monograph because the API has a limit of 0.3% for this impurity. It is anticipated that the proposed revision will be published as an In-Process Revision in a future Pharmacopeial Forum pursuant to the Rules and Procedures.
Should you have any questions, please contact Clydewyn M. Anthony, Ph.D., Senior Scientific Liaison (301–816–8139 or cma@usp.org).
CN-21-019-00