Unambiguous Impurity Identification Reliable And Assured Quality As Job One

Understanding the levels of impurities present in finished products or their components requires process
knowledge and the technology to efficiently identify and quantify these impurities. The Food and Drug Administration (FDA) regulates the presence of impurities in drug substance and drug product to guarantee drug quality and safety, both vital in safeguarding patient care. According to a recent FDA letter to industry, 54% of drug shortages were due to quality issues.

Impurities can have a significant impact on a drug’s activity, toxicity, the production process and formulation. The FDA has therefore mandated the monitoring of impurities throughout the entire development process and post-marketing. New impurities in drug substances or products can arise unexpectedly from many different potential sources. The impact of changes in impurity profile becomes progressively more dramatic in later stages of development. Changes in the synthetic route, modifications in the formulation, and instability during storage are just a few examples. Depending on dose and whether a drug substance or drug product is considered, impurities must be identified or qualified when levels rise above 0.05 to 0.15%2. Resolution of the issue then becomes an immediate necessity, often including structure determination, synthetic confirmation and toxicological testing.