Type of Posting: Notice of Intent to Revise
Posting Date: 27–July–2018
Targeted Official Date: August 1, 2020; First Supplement to USP 43–NF 38
Expert Committee: General Chapters—Chemical Analysis
In accordance with section 7.04(c) of the Rules and Procedures of the Council of Experts, this is to provide notice that the General Chapters–Chemical Analysis Expert Committee intends to revise the chloride identification tests in the General Chapter ⟨191⟩ Identification Tests-General and the cross-referenced monographs.
The proposed revisions to this General Chapter and around thirty impacted monographs will be published for public comment in the Pharmacopeial Forum (PF) 45(2) [Mar.–Apr. 2019] on March 1, 2019, pursuant to section 7.02 of the Rules and Procedures.
Based on comments from users, a revision to the chloride identification tests described in General Chapter <191> Identification Tests – General, is being proposed. The purpose of this batch revision is to merge the current test A and B, and to remove test C.
Tests A and B are typically performed together to meet the requirements (more common case). When a specific test, either A or B, is needed, it will be so stated in the particular monograph, as applicable.
Test C will be omitted because it implies the evolution of chlorine gas, which makes it obsolete. The two monographs that currently require test C will now include the wording of the test in the particular monograph, until a suitable replacement is found.
To allow additional time for public review and comment, the proposed revisions and a list of impacted monographs are included here in advance of the chapter's publication in PF 45(2).
Comments will be accepted until May 31, 2019, the end of the comment period for PF 45(2). In the absence of any adverse comments the proposed batch revisions will become official in the First Supplement to USP 43-NF 38 on August 1, 2020.
Should you have any questions, please contact Antonio Hernandez-Cardoso, Senior Scientific Liaison, at firstname.lastname@example.org.