Impurities may occur through chemical reaction and degradation during API and drug product production and storage, as the result of remaining residual solvents or due to the introduction of contaminants. Furthermore, the contacting materials introduced during production and storage may introduce extractables and leachables (E&L).
Determine the path to mitigate downstream product risk. Our experts help you determine and quantify the impact of potential genotoxic impurities on drug efficacy through toxicological risk. We possess detailed ICH and USP regulatory knowledge regarding the control of impurities and their associated levels in new drug products and new drug substances.
With our expertise in chemical synthesis, drug product formulation development, bioprocessing and small- and large-scale API manufacturing, along with analytical expertise in stability programs, release testing, structure elucidation and E&L determination, we provide significant resources and probability of success to address your impurity needs.
Our capabilities include:
- Identification of impurities
- Method development and validation to determine type and level of impurities
- Use of analytical instrumentation (mass spectrometry and NMR) for structure elucidation
Contact our analytical testing team by clicking below