BRIEFING

 Haloperidol Decanoate Injection. Because there is no existing USP monograph for this drug product, a new monograph based on validated methods of analysis is being proposed. The liquid chromatographic procedure in the Assay and the test for Organic Impurities was validated using the XBridge C18 brand of column with L1 packing. The typical retention time for haloperidol decanoate is about 46 min.

 (SM4: S. Dragan)

 Case ID—SUB-357