Type of Posting: Notice of Intent to Revise
Posting Date: 30-Sep-2022
Targeted Official Date: 01-Dec-2022
Expert Committee: Small Molecules 2
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 2 Expert Committee intends to revise the Naloxone Hydrochloride monograph.
Comments were received indicating that the Sensitivity solution has the same concentration as the Standard solution in the Limit of Naloxone Related Compound D test as published in the version to be official on Dec 1, 2022 for Naloxone Hydrochloride monograph.
Based on the review of supporting data, it was found that the signal-to-noise ratio requirement is not necessary for the Limit of Naloxone Related Compound D test. The Expert Committee intends to revise the Naloxone Hydrochloride monograph to delete the Sensitivity solution and the corresponding signal-to-noise ratio requirement in the Limit of Naloxone Related Compound D test. The remaining listed requirements are sufficient to demonstrate system suitability.
It is anticipated that this revision will be implemented using a suitable accelerated revision process and will become official on Dec 1, 2022.
Should you have any questions, please contact Yanyin Yang, Senior Scientist II. (email@example.com)