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.
Involves a complete process, from the structural elucidation of impurities to its toxicological evaluation and characterization.
Source of impurity identification
Toxicological
Evaluation
Risk
Assesment
Control
Strategy
Toxicological
Report
Azierta, leading toxicology consultancy, performs complete studies of the following impurities
Nitrosamine Impurities
Extractable and Leachable impurities
Elemental impurities
Organic impurities
Mutagenic impurities
Nitrosamine Impurities
- MAHs were asked by the CHMP to review all chemical and biological human medicines for possible presence of nitrosamines and test products at risk.
- Control strategies to prevent or limit the presence of these impurities, and when necessary, improve the manufacturing processes is also required for companies.
- At Azierta, we offer a global service that covers all the steps required, from the risk analysis, analytical phase to the regulatory support with variation management.
- We have a multidisciplinary team, with great experience implementing the ICH Q9 quality management regulations and in the evaluation and control of mutagenic impurities according to ICH M7.
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 Azierta, 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 Azierta, 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 Azierta, 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 Azierta, we offer a comprehensive service covering everything from the structural elucidation of impurities to toxicological evaluation and characterisation.
We have a specialized area in Toxicological support composed of a multidisciplinary team of toxicologists and chemical experts accredited by AETOX, EUROTOX and ERT
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