Organic and Mutagenic Impurities
- Preclinical and safety studies
- Qualitative and quantitative analyses
- Toxicological reports
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.
We are happy to assist you with this detailed toxicological work. You benefit from a comprehensive service: from structural elucidation of the contaminants to toxicological assessment and risk characterisation – everything is possible.
Our Services
Preclinical and
Safety Studies
In vivo testing
In vitro testing
Mutagenicity
Carcinogenicity
Reproductive toxicity
Pharmacokinetics
Qualitative and
quantitative analysis
Isolation of the impurity using
- Chromatography
- Crystallography
Identification of the impurity
- Exact weight
- Molecular formula
- Chemical structure
- Separation of enantiomers
Toxicological
Reports
Toxicological assessment
- Preclinical data
- Clinical data
- In silico tools: QSAR and read-across
- Metabolism
Risk characterisation
Control strategies
- Name and address of the company
- Description of the impurity
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