A PHASE APPROPRIATE APPROACH TO RP-HPLC METHOD DEVELOPMENT FOR IMPURITIES ANALYSIS IN ACTIVE PHARMACEUTICAL INGREDIENTS VIA CONTINUOUS MANUFACTURING PROCESS UNDERSTANDING

摘要: A concept of a systematic approach to the development phase appropriate RP-HPLC methods for quantifying organic impurities in Active Pharmaceutical Ingredients (APIs) is presented. This dynamic and practical emphasizes utilization comprehensive chromatographic knowledge gained throughout lifecycle drug based on continuous understanding API manufacturing process. At beginning project, database can be built by scouting relevant carefully selected columns, different modifiers pHs with only two gradient runs each combination column, modifier, pH. contains experimental data predicted separations simulation software (e.g., DryLab®). Once this established, an method from pre-defined chromatographic...