부산대학교 도서관

This review article discusses scientific rationales and current best practices in the pharmaceutical industry for performing chromatographic peak purity assessments (PPA). These activities are associated with the development and validation of liquid chromatographic (LC) stability-indicating analytical methods applicable to regulatory submissions of small-molecule drug candidates. The discussion includes a comprehensive overview of the PPA-related regulatory and scientific landscape and common industry approaches to obtain PPA results, as well as the strengths and weaknesses of PDA-facilitated ultraviolet (UV) PPA and other PPA techniques.
THE EXECUTION of chromatographic peak purity assessments (PPAs) is associated with the development of stability-indicating analytical methods (SIM) applicable to regulatory submissions (marketing applications) by pharmaceutical companies. When developing these [...]