BRIEFING

 Budesonide Extended-Release Tablets. 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 was validated using the Discovery C18 brand of column with L1 packing. The typical retention times for budesonide epimer B and budesonide epimer A are about 14 and 15 min, respectively.

2. The liquid chromatographic procedure in the Dissolution test was validated using the Discovery C18 brand of column with L1 packing. The typical retention times for budesonide epimer B and budesonide epimer A are about 11 and 12 min, respectively.

3. The liquid chromatographic procedure in the Organic Impurities test was validated using the Hypersil BDS C18 brand of column with L1 packing. The typical retention times for budesonide epimer B and budesonide epimer A are about 38 and 40 min, respectively.

 (SM5: S. Singireddy)

 Case ID—SUB-610