Impurity profile: Significance in Active Pharmaceutical Ingredient

[摘要] Various regulatory authorities like ICH, USFDA, Canadian Drug and Health Agency are emphasizing on the purity requirements and the identification of impurities in Active Pharmaceutical Ingredient’s (API’s). Qualification of the impurities is the process of acquiring and evaluating data that establishes biological safety of an individual impurity; thus, revealing the need and scope of impurity profiling of drugs in pharmaceutical research.

[学科分类] 分析化学

[关键词] Spectrophotometry; Artesunate; Falcigo; Safranin O; Variamine blue