Avoiding Major Issues in the Bioanalysis of Prasugrel by LC-MS/MS: Thorough Investigation of Incurred Samples and Reference Standard Materials

摘要

Thorough investigation led us to discover that the available reference standard material for R-138727 was the trans isomer, while the cis isomer is produce in vitro. This is a clear example that scientific vigilance and critical thinking is a "must" when developing and validating methods in a regulated bioanalytical environment.