Type of Posting: Notice of Intent to Revise
Posting Date: 17–April–2015
Targeted Official Date: Revision Bulletin (Postponement), 01–May–2015; Interim Revision Announcement, 01–Jan–2016
Expert Committee: Monographs—Small Molecules 4
In accordance with section 7.05(c) of the Rules and Procedures of the Council of Experts, this is to provide notice that the USP Monographs—Small Molecules 4 Expert Committee intends to revise the Methocarbamol Tablets monograph. The latest revision to the Methocarbamol Tablets monograph was proposed in Pharmacopeial Forum 39(6) and published in USP 38–NF 33, which will become official on May 1, 2015.
It has come to the attention of the Council of Experts that the acceptance criteria of the specified impurities and total impurities in the recently revised Methocarbamol Tablets monograph are inconsistent with the limits in the methocarbamol drug substance monograph. The limit of total impurities in the Methocarbamol monograph is NMT 2.0%, while it is NMT 1.0% in the Methocarbamol Tablets monograph. The ICH guidelines state that limits of the specified impurities and total impurities in a drug substance monograph can be either less than or equal to the limits of the specified degradation products and total degradation products in a finished dosage form.
Pursuant to section 7.02 of the Rules and Procedures, it is anticipated that the Revision Bulletin to postpone the Organic Impurities procedure in the Methocarbamol Tablets monograph will be published on USP’s website on April 28, 2015 and become official May 1, 2015.
Should you have questions, please contact Ravi Ravichandran, Ph.D., Principal Scientific Liaison to the Expert Committee (301-816-8330 or rr@usp.org).