Organic and Mutagenic 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 and mutagenic impurities ICH M7.

To justify organic and mutagenic impurities, it is necessary to identify the impurity and analyse it in order to subsequently assess the risk it may involve for human health.

You benefit from a comprehensive service covering everything from the structural elucidation of impurities to toxicological evaluation and characterisation. To do this, we use a specialised process:

This is what we need from you to prepare a binding, fixed price quote:

Our Services:

Pre-clinical studies and safety studies

  • In vivo testing
  • In vitro testing
  • Mutagenicity
  • Carcinogenicity
  • Reproductive toxicity
  • Pharmacokinetics

Qualitative-quantitative analysis

  • Isolation of the impurity
    - Chromatographic techniques
    - Crystallographic techniques
  • Impurity identification
    - Exact mass
    - Molecular formula
    - Chemical structure
    - Enantiomeric resolution

Toxicological report

  • Toxicological evaluation
    - Preclinical data
    - Clinical data
    - In silico tools: QSAR and Read Across
    - Drug metabolism review
  • Characterisation of the risk
  • Control strategies


Due to the individual specifications of medicinal products, we cannot offer a fixed price for these risk assessments. We will be pleased to send you a binding, fixed price quote after verifying the critical key data.

Why can we offer toxicological reports for such a competitive price?

Our partner Azierta is the market leader in Spain for the preparation of toxicological assessments and employs approximately 15 toxicologists for the preparation of assessments. These are also successfully used by the industry in other European countries (e.g. Germany, Switzerland, Italy, Belgium) and have been accepted by the authorities.

Contact us now for your individual fixed price offer: