The Identification and analysis of impurities to assess the risk it may pose for human health is essential in the Pharmaceutical Industry. Involves a complete process, from the structural elucidation of impurities to its toxicological evaluation and characterization.
Maven, leading toxicology consultancy, performs complete studies of the following impurities:
Extractable and Leachable impurities:
Organic impurities:
- When an impurity in a medication reaches or exceeds the qualification level,the manufacturer must justify the toxicity of the impurity in accordance with the established regulations for organic impurities ICH Q3A/Q3B.
- At Maven, we offer a comprehensive service covering everything from the structural elucidation of impurities to toxicological evaluation and characterisation. To do this, we use a specialised process.
Mutagenic impurities:
- When a mutagenic impurity in a medication reaches or exceeds the qualification level,the manufacturer must justify the toxicity of the impurity in accordance with ICH M7 guideline.
- To justify mutagenic impurities, it is necessary to identify the impurity and analyse it to subsequently assess the risk it may involve for human health.
- At Maven, we offer a comprehensive service covering everything from the structural elucidation of impurities to toxicological evaluation and characterisation.
