- The limits in the test for Organic Impurities Procedure 3 will be revised to reflect FDA-approved acceptance criteria.
- The concentrations of the standards in the Stock standard solution in Organic Impurities Procedure 4 will be corrected.
USP recently determined there were accelerated revision icons incorrectly associated with five reagents affecting both the USP 37–NF 32 Second Supplement online publication (posted on June 1, 2014 and official December 1, 2014) and the USP 38-NF 33 online publication (posted on November 1, 2014 to become official on May 1, 2015). There are no accelerated revisions associated with these reagents.
The affected reagents and publications are:
USP 37–NF 32 Second Supplement Online -
In accordance with section 7.05 (c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the Monographs—Dietary Supplements and Herbal Medicines Expert Committee intends to revise Menthol monograph.
Comments and data received shows that menthol obtained from natural sources does not meet the current limit of 0.1% for Individual impurities indicated in the monograph. The Expert Committee intends to increase the limit for Individual impurities to 0.3% based on the data submitted to USP.