Genotoxic Impurity Testing
Potentially mutagenic impurities may require analytical controls at levels substantially below those used for routine impurity testing.
Teleios supports development of sensitive analytical procedures for targeted mutagenic impurity investigations.
What We Can Support
- Targeted impurity methods
- Low level quantitation
- Method development and validation
- Process related impurity investigations
- Degradation related impurity testing
- Analytical troubleshooting
Typical Analytical Questions
- Can the impurity be measured at the required control level?
- Is the procedure sufficiently selective in the product matrix?
- Does the impurity require routine monitoring?
- Can process changes reduce or control the impurity?
Analytical Approach
Trace level procedures are designed around the required control threshold, with sample preparation and detection selected to achieve quantitation in the relevant product matrix.
Regulatory & Compendial Framework
Depending on the program, material, and intended use, studies may consider:
- ICH M7(R2) — Assessment and Control of DNA Reactive Mutagenic Impurities in Pharmaceuticals
- Relevant impurity control strategy principles
- Applicable regulatory expectations for reporting and control
Not every listed framework applies to every study. Applicable expectations depend on product type, development stage, route of administration, material, intended use, and jurisdiction.