BRIEFING

 Lidocaine Hydrochloride and Epinephrine Buffered Compounded Injection. Because there is no existing USP monograph for this compounded preparation, a new monograph based on a validated stability-indicating method for assessing stability is proposed. The liquid chromatographic procedure in the Assay is based on analyses validated using the Kromasil C18 brand of analytical column with L1 packing for lidocaine hydrochloride and using the Viva Biphenyl brand of analytical column with L11 packing for epinephrine. The typical retention time for lidocaine hydrochloride is about 13.4 min. The typical retention time for epinephrine is about 5.4 min.

 Please submit comments to CompoundingSL@usp.org.

 (CMP: B. Groat)

 Case ID—SUB-725