Toxicological Evaluation of Impurities and Risk Analysis
The identification and analysis of impurities to assess the risk they may pose for human health is essential in the pharmaceutical industry. It involves a complete process, from the structural elucidation of impurities to their toxicological evaluation and characterization.
Extractable and Leachable Impurities
ICH Q3D Guideline limits the presence of potentially toxic elemental impurities in human medicines. At MAVEN, we perform risk assessment of each impurity to implement ICH Q3D guidelines following an exhaustive methodology.
Organic Impurities
When an impurity in a medication reaches or exceeds the qualification level, the manufacturer must justify its toxicity in accordance with ICH Q3A/Q3B guidelines. MAVEN provides a comprehensive service covering structural elucidation, toxicological evaluation, and characterization of these impurities.
Mutagenic Impurities
For mutagenic impurities exceeding the qualification level, toxicity justification is required as per ICH M7 guideline. MAVEN identifies and analyzes mutagenic impurities, assessing the associated human health risks with a thorough and standardized process.
