What Goes Wrong When API Quality is Compromised?

Effective and safe APIs provide the necessary element of drugs to treat patients with a variety of health conditions. It is, therefore, crucial that the quality of APIs, along with other ingredients that make up a medicine, is of primary importance to drug developers and manufacturers.

“Continual advances in the sensitivity, specificity, and accuracy of analytical technologies contribute to increasing confidence in the ability of API manufacturers to ensure the quality of final API products,” says James Lawler, general managerat C2 PHARMA. “For small-molecule APIs, common techniques include Raman, ultraviolet, infrared, and UV spectroscopy; HPLC; LC–MS; LC–tandem MS (MS/MS); GC; GC–MS and GC–MS/MS; and particle analysis, among others. These methods are used during product and process development and for final API release. GMP drug substance release testing requirements are extensive and include testing materials against specification for identity, purity, the level of impurities, certain physical properties, among other attributes. The specific requirements depend on the modality.”

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