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Protect Patient Health & Meet Global Compliance Standards

Nitrosamines—potent carcinogens linked to pharmaceutical impurities—pose critical risks to drug safety. With global regulators like the FDA, EMA, and WHO 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

Nitrosamine testing

Our end-to-end services ensure compliance and confidence:
High-Throughput Screening: Rapid detection of trace-level nitrosamines, including NDSRIs (Nitrosamine Drug Substance-Related Impurities).
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 Prioritize 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.

Nitrosamine
QTOF Instrument at Eurofins BPT India

Navigating Regulatory Complexity

Regulators demand rigorous risk assessments and limits (e.g., AI/PMOEL thresholds). Eurofins simplifies compliance with:
• Updated guidance tracking for FDA, EMA, and ICH.
• Customized testing protocols for APIs, finished drugs, and excipients.
• Audit-ready documentation to facilitate accelerated approvals.

FAQs: Your Nitrosamine Testing Questions Answered

1. What are nitrosamines, and why are they regulated?
Nitrosamines are carcinogenic impurities formed during drug manufacturing or storage. Global agencies mandate testing to limit patient exposure.
2. Which drugs require nitrosamine testing?
Drug substances with certain amine structures, specific synthesis processes, and contaminated raw materials that may be prone to nitrosamine formation. Commonly affected drug classes include sartans, statins, ranitidine, metformin, rifampicin, rifampin, etc.
3. How do you validate testing methods?
We follow ICH Q2(R1) guidelines, ensuring specificity, sensitivity, and reproducibility for your product matrix.
4. How can Eurofins BioPharma Product Testing India assist with nitrosamine testing?
We offer a suite of nitrosamine and NDSRI testing services, including risk assessment, method development, validation, and routine batch analysis, enabling full compliance with regulatory requirements and industry best practices.
5. Why choose Eurofins?
Over 20 years of expertise, state-of-the-art labs, and future-proof your compliance.

Partner with Eurofins for Trusted Results
With 400+ successful nitrosamine projects delivered, we empower pharmaceutical and biotech companies to deliver safer therapies.

Eurofins BioPharma Product Testing India – Where Precision Meets Compliance.