BRIEFING

 Potassium Sorbate. This proposal is based on the version of the monograph official as of November 1, 2020. On the basis of stakeholder feedback emphasizing improved quality control for this excipient, particularly regarding purity, and a validated method of analysis developed by USP's internal laboratory, it is being proposed to add a test for Organic Impurities that employs an HPLC procedure based on analyses performed with the Bio-Rad Aminex HPX-87H brand of column with L17 packing. The typical retention times for malonic acid, potassium sorbate isomers, and potassium sorbate are approximately 9.7, 49.7, and 54.1 min, respectively.

 The current Assay for Content of Potassium Sorbate is not suitable for organic impurity analysis because of its lack of specificity for known impurities, except for potassium sorbate isomers. The proposed Organic Impurities test, while more specific for impurity analysis, is not ideal for use as the Assay because of its significantly longer run time.

 Additionally, minor editorial changes have been made to update the monograph to current USP style.

 (EXC1: P. Zhang)

 Case ID—SUB-587