A PHASE APPROPRIATE APPROACH TO RP-HPLC METHOD DEVELOPMENT FOR IMPURITIES ANALYSIS IN ACTIVE PHARMACEUTICAL INGREDIENTS VIA CONTINUOUS MANUFACTURING PROCESS UNDERSTANDING
Contributor(s):: Yang, S, Li, YChen, TK, Kord, AS
A concept of a systematic approach to the development of phase appropriate RP-HPLC methods for quantifying organic impurities in Active Pharmaceutical Ingredients (APIs) is presented. This dynamic and practical approach emphasizes the utilization of comprehensive chromatographic knowledge gained...