Nitrosamine testing and NDSRI analysis services
Protect patient health and meet global compliance standards

Nitrosamines potent carcinogens linked to pharmaceutical impurities pose critical risks to drug safety. With global regulators like the Food And Drug Administration, European Medicines Agency, and World Health Organisation enforcing strict limits, proactive testing will ensure regulatory compliance, patient safety and brand protection.
Eurofins BioPharma Product Testing India provides advanced nitrosamine analysis solutions, enabling smooth regulatory compliance and ensuring patient safety.

Comprehensive nitrosamine testing solutions
We perform nitrosamine testing studies for:

Our end-to-end services ensure compliance and confidence:

• High-throughput screening: Rapid detection of trace-level nitrosamines, including NDSRIs.
• Advanced analytical techniques: LC-MS/MS, GC-MS/MS, and HPLC-UV for unmatched sensitivity   and accuracy.
• End-to-end expertise: Method development, validation, and batch analysis tailored to your product’s  needs.
• Regulatory compliance: Solutions aligned with FDA, EMA, ICH M7(R2), and WHO guidelines.

Why prioritise nitrosamine testing?

• Patient safety: Even traces of nitrosamines can pose cancer risks over time.
• Regulatory compliance: Avoid recalls, delays, or penalties by meeting evolving global standards
• Brand protection: Proactive testing mitigates reputational and financial risks.

Our analytical excellence

Leverage gold-standard technologies for precise results:

1. LC-MS/MS: Detects non-volatile nitrosamines at parts-per-billion (ppb) levels.
2. GC-MS/MS: Ideal for volatile impurities that require superior separation capabilities.
3. HPLC-UV/FLD: Cost-effective screening for routine analysis
   
   

Navigating regulatory complexity

Regulators demand rigorous risk assessments and limits (e.g., AI/PMOEL thresholds). Eurofins BioPharma Product Testing simplifies compliance with:

• Updated guidance tracking for FDA, EMA, and ICH.
• Customised testing protocols for APIs, finished drugs, and excipients.
• Audit-ready documentation to facilitate accelerated approvals.