Posting Date: 01–May–2015
Revised Date: 25–Mar–2016
Official Date: 01–May–2015
Expert Committee: Monographs— Small Molecules 4
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has indefinitely postponed the test for Organic Impurities in the Methocarbamol Tablets monograph.
It has come to Expert Committee’s attention that the limits of the specified impurities and total impurities in the recently revised Methocarbamol monograph are inconsistent with ICH guidelines, which 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. The limit of total impurities in the Methocarbamol monograph is NMT 2.0%, while it is NMT 1.0% in the Methocarbamol Tablets monograph
In is anticipated that the Monographs—Small Molecules 4 Expert Committee will propose a revision to Methocarbamol monograph in Pharmacopeial Forum 41(4) [Jul.–Aug. 2015] with FDA approved limits, which will remove the inconsistency between the drug substance and drug product monograph.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
This Methocarbamol Tablets Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the First Supplement to USP 39–NF 34.
Should you have any questions, please contact Ravi Ravichandran, Ph.D. (301-816-8330, rr@usp.org).