Toxicological Evaluation Of Impurities And Risk Analysis

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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 guidelines 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 guidelines.
  • To justify mutagenic impurities, it is necessary to identify the impurity and analyze 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 characterization.