Nitrosamine impurities
Risk assessment of the presence of nitrosamine impurities according to ICHM7 and ICHQ9 guidelines
Impurities
Risk
Assesment
Confirmation
Tests
Toxicological
Evaluation
Extractable and Leachables Impurities
Toxicological assessment of potential nitrosamine impurities as those originated from the synthetic pathway, according to ICH M7.
- Bibliographic reviews of preclinical and clinical toxicity data.
- Pharmacokinetics and metabolism data.
- Safe exposure limits estimation for the impurity.
Elemental Impurities
ICH Q3C Guideline is focused on residual solvents of all type of products. It recommends acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient.
At Azierta, we perform the Risk Assessment to implement ICH Q3C guideline following an exhaustive methodology.
Organic Impurities
Toxicological assessment of organic impurities as degradation products from APIs, according to ICH Q3A/B.
- Bibliographic reviews of preclinical and clinical toxicity data available.
- Pharmacokinetics and metabolism data.
- Qualification of the impurity through a specific limit for it or according to metabolism.
Mutagenic Impurities
Toxicological assessment of potential mutagenic impurities as those originated from the synthetic pathway, according to ICH M7.
- Bibliographic reviews of genotoxicity and carcinogenicity data available.
- In silico studies if required.
- Specific limit for the impurity if required.
We have a specialized area in Toxicological support composed of a multidisciplinary team of toxicologists and chemical experts accredited by AETOX, EUROTOX and ERT
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