BRIEFING

 Glycopyrrolate Compounded Oral Suspension. 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 Symmetry C18 brand of analytical column with L1 packing. The typical retention time for glycopyrrolate is about 12.9 min.

 Please submit comments to CompoundingSL@usp.org.

 (CMP: L. Pearson)

 Case ID—SUB-978