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Pharmaceutical Impurities

Pharmaceutical impurities are active pharmaceutical ingredients  (API)   or undesirable chemical components in pharmaceutical formulations. Impurities in the bulk drug may originate from the synthesis process or other sources such as raw materials, intermediates, reagents, solvents, catalysts, and reaction by-products. During the drug development process, impurities may be:  •  formed due to the inherent instability of the API •  due to incompatibility with the added excipients, or  •  interacts with packaging materials and container sealing systems (CCS)  to produce APIs The content of various impurities in the final product determines the safety of the final product. Therefore, the identification, quantification, qualitative and control of impurities have become a key component of the drug development process.

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