Type of Posting: Notice of Intent to Revise
Posting Date: 29–Sept–2017
Expert Committee: General Chapters–Chemical Analysis
In accordance with section 7.05(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 propose several revisions to General Chapters ⟨476⟩ Organic Impurities in Drug Substances and Drug Products and ⟨1086⟩ Impurities in Drug Substances and Drug Products based on comments received on the proposals published in PF 41(3) [May-June 2015].
The proposed revisions to these General Chapters will be published for public comment in Pharmacopeial Forum (PF) 43(6) [Nov.–Dec. 2017] on November 1, 2017, pursuant to section 7.02 of the Rules and Procedures. To allow additional time for public review and comment, the proposed revisions are included below in advance of their publication in PF 43(6). These chapters will also be discussed at the October 19, 2017 Prescription/Non-prescription Stakeholder Forum, which is free to attend either in person or remotely.
- ⟨476⟩ Organic Impurities in Drug Substances and Drug Products
- ⟨1086⟩ Impurities in Drug Substances and Drug Products
Comments will be accepted until January 31, 2018, the end of the comment period for PF 43(6).
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