Genotoxic Impurity Testing

Genotoxicity generally refers to the toxicity caused by the interaction of various factors (such as physical and chemical factors) with the genetic material of cells or organisms. Genotoxic substances can cause damage to human genetic material at very low concentrations, which can lead to genetic mutations and may promote tumor development.

The genotoxic impurities in drugs not only have no positive effect on the treatment of patients, but also damage the health of patients. Therefore, pharmacopoeia of various countries have successively issued general rules for the control and detection of genotoxic impurities. Genotoxic impurity testing can analyze and evaluate the composition and content of genotoxic impurities in drugs to strictly control their limits in drugs and ensure drug safety.

STEMart provides high-quality genotoxic impurity testing services to facilitate strict control of genotoxic impurity limits in drugs, ensure drug safety and protect human health.

Test Samples

Raw material drug, auxiliary materials, finished drug, etc.

Service Items

• Evaluate possible genotoxic impurities in the process route
• Use (Q)SAR software to evaluate potential genotoxic impurities
• Conduct bacterial reverse mutation assay to evaluate potential genotoxic impurities
• Assessment of genotoxic impurity limits according to ICH M7 based on determined impurity grade
• Development and validation of analytical methodology for genotoxic impurities
• Control strategy of genotoxic impurities

For more information about our genotoxic impurity testing services, please contact us.