BRIEFING

 Buprenorphine and Naloxone Sublingual Film. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is proposed.

1. The liquid chromatographic procedure in the Assay is based on validation performed with the XBridge BEH Shield RP18 brand of column with L1 packing. The typical retention times for naloxone and buprenorphine are about 6 and 16 min, respectively.

2. The liquid chromatographic procedure in the Dissolution test is based on validation performed with the XBridge BEH Shield RP18 brand of column with L1 packing. The typical retention times for naloxone and buprenorphine are about 2 and 14 min, respectively.

3. The liquid chromatographic procedure in the Organic Impurities test is based on validation performed with the Zorbax Eclipse XDB-C8 brand of column with L7 packing. The typical retention times for naloxone and buprenorphine are about 13 and 33 min, respectively.

 (SM2: W. Yang)

 Correspondence Number—C316852