All Services
The Challenge:
Genotoxic impurities (GTIs), even at trace levels, pose serious risks to patient safety. Regulators demand rigorous identification and quantification against strict exposure targets.
Our Approach:
CLS specializes in the identification and quantification of genotoxic impurities, including volatile organic compounds. Our advanced instrumentation ensures detection at the sensitivity levels required by ICH M7 guidelines.
Why It Matters
Ultra-sensitive detection and quantification
ICH M7 (R1) compliant methodologies
Coverage of volatile and non-volatile impurities
Expert scientific interpretation of results
Applications
- Drug substance genotoxic screening
- Process impurity profiling
- Degradation product analysis
- Regulatory compliance assessments
Regulatory Standards
ICH M7 (R1)USFDAEMA
Instrumentation
LC-MS/MSGC-MS/MSICP-MS
Standards & Compliance
Every test we perform adheres to globally recognized regulatory frameworks.
ICH Q2ICH Q3DICH M7 (R1)USPEPBPJPIPFCCACSISO/IEC 17025ISO 10993-7US FDAEMACDSCO