Type of Posting: Notice of Intent to Revise
Posting Date: 24-Apr-2020
Targeted Official Date: To Be Determined, In Process Revision
Expert Committee: Chemical Medicines Monographs 2
In accordance with section 7.04 (c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that the Chemical Medicines Monographs 2 Committee intends to revise the Metyrosine Monograph.
Comments, with supporting data, received indicate that the specifications outlined for the procedure for Specific Rotation <781S> may not provide a consistent enantiomeric purity value of the Metyrosine drug substance. The Expert Committee proposes to revise the Metyrosine monograph to replace the Specific Rotation procedure with a chiral procedure to quantify the R-enantiomeric impurity content in the drug substance.
It is anticipated that the proposed revision will be published in the future as an In-process Revision in Pharmacopeial Forum (PF) pursuant to Section 7.02 of the Rules and Procedures.
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