BRIEFING

 N-Acetyl-dl-tryptophan. Because there is no existing NF monograph for this excipient, a new monograph based on validated methods of analysis is proposed. The HPLC method in the test for Organic Impurities is based on analyses performed with the Macherey-Nagel Nucleosil 100-5 C18 brand of column with L1 packing. The typical retention times for N-acetyl-dl-tryptophan and tryptophan related compound A are about 26.7 and 32.6 min, respectively.

 (SE: S. Saladi)

 Case ID-PUB-82