BRIEFING

 Dimethyl Sulfoxide Irrigation. This proposal is based on the version of the monograph official as of May 1, 2018. It is proposed to revise the monograph with the following changes:

1. The Assay procedure is replaced with a new validated gas chromatography procedure to minimize the peak fronting and the asymmetry of the peak shape. The procedure was validated using the DB-624 brand of capillary column with phase G43. The typical retention time for dimethyl sulfoxide is about 5 min.

2. Replace the use of the numerical acceptance limit with "Meets the requirements" in the Bacterial Endotoxins Test to align with the general chapter.

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

 (SM3: S. Ramakrishna)

 Correspondence Number—C279355