Impurity Identification In Small-Molecule APIs

Timely identification of impurities is critical for maintaining clinical and marketing timelines, and it requires a unique combination of process chemistry knowledge and considerable analytical capabilities. At Grace Fine Chemical Manufacturing Services (FCMS), we keep customers on track by combining decades of pharma research and development experience with teams who closely collaborate on all elements of process development, from the kilo lab to commercial production.

These teams are formed early in process development and then maintained through all phases of commercial development. This ensures that when an impurity arises, the pieces are already in place for prompt identification, and the team just needs to execute.

Impurities of principal concern are often first discovered through final product purity analysis, which for most small molecule drug substances utilizes high-performance liquid chromatography (HPLC) with UV detection. However, tracking and identification of impurities observed during in-process control testing, along with purity analysis of raw materials, is the strategy most likely to lead to successful management of a drug’s total impurity profile.