When an impurity in a medication reaches or exceeds the qualification level, the manufacturer must justify the toxicity of the impurity in accordance to 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 analyze it in order to subsequently assess the risk it may involve for human health.
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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:
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Our services in toxicity of organic and mutagenic impurities
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
We have a specialised toxicological support department composed by of a multi-disciplinary team of expert toxicologists accredited by AETOX, EUROTOX and ERT.
