TOXICOLOGICAL EVALUATION OF IMPURITIES AND RISK ANALYSIS
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:
Regulatory agencies require that toxic substances in packaging materials do not migrate into the drugs during their shelf life to avoid changes in therapeutic action, organoleptic properties, or stability.
At Maven, we perform complete studies of extractable substances and develop methods to monitorize the presence of leachable impurities in the final product.
Elemental impurities:
ICH Q3D Guideline is focused to limit the presence of potentially toxic elemental impurities in human medicines.
At Maven, we perform the Risk Assessment of each impurity to implement ICH Q3D guideline following an exhaustive methodology.
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.
About Us
Welcome to Maven, one of the best Regulatory Consultants that is setup by real life working professionals with very rich experience. We at Maven understand the customers pulse and reach their expectations. We are unique and focus on quality is our prime goal. Maven works with any range of company that is looking for quality and in time delivery of services.