BRIEFING

 Levulinic Acid. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods of analysis is proposed. The proposed HPLC method in the test for Assay and Limit of 5-Methylfuran-2(5H)-one is based on analyses performed with the Avantor-Prevail Organic Acid brand of column with L1 packing. The typical retention times for formic acid, acetic acid, levulinic acid, 5-methylfuran-2(5H)-one, and furfural are about 2.36, 3.80, 8.12, 9.83, and 11.14 min, respectively.

 (SE: S. Saladi)

 Case ID—SUB-365