Buprenorphine Compounded Sublingual Solution
BRIEFING
Buprenorphine Compounded Sublingual Solution. Because there is no existing USP monograph for this compounded preparation, a new monograph based on a validated stability-indicating method is being proposed. The liquid chromatographic procedure in the Assay is based on analyses validated using the Kinetex XB-C18 brand of column with L1 packing. The typical retention time for buprenorphine hydrochloride is about 7.3 min.
Please submit comments to CompoundingSL@usp.org.
(CMP: B. Groat)
Case ID—SUB-1296