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Bicalutamide Tablets

Type of Posting: Notice of Intent to Revise
Posting Date: 16-Dec-2022
Targeted Official Date: 01-Sep-2023; Interim Revision Announcement
Expert Committee: Small Molecules 3

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 3 Expert Committee intends to revise the Bicalutamide Tablets monograph.

Based on the comments received with supporting data, the Expert Committee proposes to add the UV cell path length of 0.1 cm to both Dissolution Test 1 and the Procedure for content uniformity in the Uniformity of Dosage Units section. 

In addition, the following changes are proposed to both Assay and Limit of 4-Amino-2-(Trifluoromethyl)benzonitrile tests: 

  • Add run time;
  • Change the System suitability requirement of resolution from “Greater than 1.9” to “NLT 2.0” and the tailing factor from “Less than 1.3” to “NMT 1.2”. 

Additional changes are also proposed for clarity.

It is anticipated that the proposed revision will be published as a proposed Interim Revision Announcement (IRA) in Pharmacopeial Forum 49(2) [Mar.- Apr. 2023] pursuant to the Rules and Procedures. The comment period for this revision would end on May 31, 2023. In the absence of any adverse comments, the proposed IRA would become official on September 1, 2023.

Should you have any questions, please contact Jane Li, Senior Scientist II (