BRIEFING

 Benzalkonium Chloride. This proposal is based on the version of the monograph official as of August 1, 2013. On the basis of comments received, it is being proposed to revise the Assay for Total Alkylbenzyldimethylammonium Chlorides to replace the current titrimetric method that uses visual detection with a titration method that uses potentiometric detection. This will reduce hazardous chemical usage and minimize bias with endpoint determination. The potentiometric detection is accomplished by using a surfactant-sensing electrode in combination with a reference electrode. This method will also apply to the Benzalkonium Chloride Solution monograph; please see the Briefing for that excipient in this PF.

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

 (EXC1: A. Chang)

 Case ID—SUB-3009