3. TOXICOLOGICAL EVALUATION ON ORGANIC IMPURITIES
To guarantee the quality of the pharmaceutical product it is necessary to control the presence of impurities, coming from API synthesis or from degradation of the API or the drug product.
The identification of impurities, the toxicological qualification of those that exceed their specification and the development of analytical methods are the tools available to control the presence of impurities and ensure the effectiveness and safety of the pharmaceutical product.
At Dalia we carry out risk analysis of organic impurities in accordance with the ICH Q3A / ICH Q3B regulation, evaluating the toxicological risk and guaranteeing patient safety.