Analytical Method Saves Dual-API Injectable Project From Stalling

A mid-sized client faced a significant challenge in developing a stability-indicating analytical method for a dual-API injectable drug product. This project required accurately quantifying both APIs and their related substances in a formulation designed for sterile injection. The lack of a robust method threatened to stall the entire project, including formulation development, stability studies, and clinical release.

The solution involved a detailed method development approach, including column selection, mobile phase optimization, and forced degradation studies under conditions like basic, acidic, oxidative, thermal, and photolytic stress. This allowed for the specific assignment of degradants to their parent APIs. The final method achieved excellent linearity, high precision (variability <2% at standard range), and maintained mass balance under all stress conditions, enabling the client to progress confidently. Discover the full analytical approach that saved this critical project.