Finding Impurities And Controlling Formations At Release

By Geraldine Su, Ken Strassberger, Craig Kramer, Xinqun Huang, and Mike Markham, Adare Pharma Solutions

The Challenge

Adare Pharma Solutions was selected to identify and remediate impurities found during analysis of an Active Pharmaceutical Ingredient (API). API can present challenges for the formulation and analysis of drug products, especially when they are unstable. An imperative factor during the manufacturing process is to keep the introduction or generation of impurities to a minimum. Care must be taken when developing an analytical method, as more common extraction methods can result in the generation of impurities. Determining the amount of impurities generated during analysis is critical in order to accurately determine those generated during the manufacturing process.