BRIEFING

 Karaya Gum. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods of analysis is proposed. The chromatographic procedure in the Assay is based on analyses performed with the XBridge BEH-C18 brand of column with L1 packing. The typical retention times for rhamnose, d-glucuronic acid, galacturonic acid, galactose, and arabinose are about 11.86, 23.33, 30.87, 37.83, and 39.98 min, respectively.

 (CE: D. Chavan)

 Case ID—SUB-737