Drug Impurities

Impurities in drug substances or pharmaceutical products are any chemical substances that are not the Active Pharmaceutical Ingredient (API) or an excipient, and they can impact drug safety and efficacy. Their identification, quantification, and control are critical throughout the drug development process, as they may arise from materials, by-products, degradation, or packaging.

AMSbiopharma specializes in the analysis of nitrosamine impurities, helping clients ensure compliance with regulatory daily intake thresholds for these potential carcinogens. We also offer advanced methods for detecting NDSRIs (Nitrosamines Derived from Ingredient-Related Substances), a growing concern in pharmaceutical safety, ensuring your products meet the highest standards.