Type of Posting: Notice of Intent to Revise
Posting Date: 26–Jun–2020
Targeted Official Date: 01–Mar–2021, Interim Revision Announcement
Expert Committee: Small Molecules 4
In accordance with section 9.04(c) of the 2020–2025 Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 4 Expert Committee intends to revise the Triamcinolone Acetonide Nasal Spray monograph.
Comments were received identifying an error in the revised instruction for the preparation of the System suitability solution in the Content of Benzalkonium Chloride test, which became official on May 1, 2019. The instruction failed to include a requirement to add an amount of water equal to 30% of the flask volume prior to adding Diluent. The omission of water from the solvent has resulted in poor peak shapes in the chromatogram from the System suitability solution. The proposed revision corrects the instruction for the preparation of the System suitability solution.
It is anticipated that the proposed revision will be published as a proposed Interim Revision Announcement (IRA) in Pharmacopeial Forum 46(5) [Sep.–Oct. 2020] pursuant to the Rules and Procedures. The comment period for this revision ends on November 30, 2020. In the absence of any adverse comments the proposed IRA will become official on March 1, 2021.
Should you have any questions, please contact Nicholas Garito, Scientific Liaison to the Small Molecules 4 Expert Committee (301–816–8321 or firstname.lastname@example.org).