About This Service
AnalytiLab offers highly sensitive nitrosamine and NDSRI (Nitrosamine Drug Substance Related Impurities) testing using LC-MS/MS. Our validated methods detect nitrosamines at sub-ppm levels in APIs, drug products, and excipients. We support pharmaceutical companies in their nitrosamine risk assessment and control strategy as required by FDA and EMA.
Key Information
Accredited by
What's Included
Instruments Used
LCMS/MS (Triple Quadrupole)
Nitrosamine detection at sub-ppm levels
GC-MS/MS
Volatile nitrosamine analysis (NDMA, NDEA)
HPLC-UV
Screening and confirmation
Headspace GC-MS
Volatile nitrosamine screening
Regulatory Standards
How We Work
Risk Assessment
Nitrosamine risk assessment per FDA/EMA guidance; identification of potential nitrosamines.
Method Selection
Appropriate LC-MS/MS or GC-MS/MS method selected based on nitrosamine type.
Sensitive Analysis
Analysis at sub-ppm levels with certified reference standards and internal standards.
AI Comparison & Report
Results compared against Acceptable Intake limits; regulatory-ready report issued.
Ready to Start Your Nitrosamine / NDSRI Testing?
Our scientific team is ready to assist. Submit your sample or request a quote today.
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