Nitrosamine Testing & Analysis –
Safeguarding Pharmaceutical Safety
& Compliance
Tiniest Tummies
Nitrosamines are potentially carcinogenic impurities that can form during the manufacturing or storage of pharmaceutical products, particularly in certain APIs and finished dosage forms. Global regulatory agencies, including USFDA, EMA, and CDSCO, have established strict limits for nitrosamine levels to ensure patient safety. At SIMA LABS, we provide sensitive and reliable nitrosamine testing in compliance with international guidelines. Using advanced analytical techniques such as GC-MS/MS and LC-MS/MS, we detect and quantify nitrosamines at ultra-trace levels, helping manufacturers meet regulatory requirements, protect brand reputation, and ensure product safety from production to market release.
Why Choose SIMA LABS for Nitrosamine Testing & Analysis?
- Global Regulatory Compliance – Testing as per USFDA, EMA, ICH M7, and CDSCO requirements.
- Ultra-Trace Detection – Accurate quantification down to parts-per-billion (ppb) levels.
- Advanced Technology – LC-MS/MS, GC-MS/MS, and validated nitrosamine-specific methods.
- Comprehensive Scope – APIs, finished products, intermediates, and raw materials.
- Rapid Turnaround – Fast, reliable results for market release and compliance checks.
- Regulatory-Ready Documentation – Accepted by domestic and international authorities.
35+ Years of SIMA LABS – Nitrosamine Testing & Analysis You Can Trust
SIMA LABS is NABL accredited and approved under FSSR and BIS for nitrosamine testing in compliance with USFDA, EMA, ICH M7, and CDSCO guidelines. Our testing methods are fully validated, ensuring accurate detection and quantification of nitrosamines at ultra-trace levels for regulatory submissions, product release, and export compliance.
We provide comprehensive nitrosamine testing to help pharmaceutical manufacturers meet global safety standards and maintain product integrity.
Scope of Testing:
Materials Covered:
Active Pharmaceutical Ingredients (APIs)
Finished dosage forms (tablets, capsules, injectables, etc.)
Intermediates and raw materials
Nitrosamines Detected:
N-Nitrosodimethylamine (NDMA)
N-Nitrosodiethylamine (NDEA)
N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)
N-Nitrosopiperidine (NPIP)
N-Nitrosopyrrolidine (NPYR)
N-Nitrosoethylisopropylamine (NEIPA)
Other nitrosamines as per regulatory guidance
Technology Used:
LC-MS/MS (Liquid Chromatography–Tandem Mass Spectrometry)
GC-MS/MS (Gas Chromatography–Tandem Mass Spectrometry)
Regulatory Compliance:
USFDA & EMA nitrosamine guidelines
ICH M7 genotoxic impurity limits
CDSCO and WHO safety requirements
With state-of-the-art instrumentation, validated methods, and expert analysts, SIMA LABS ensures your products meet the strictest global safety and quality standards.
Trusted by leading brands
our customers are the driving force behind our growth and innovation
Precision. Compliance. Innovation
Our Expertise
At Sima Labs, we specialize in advanced analytical testing, regulatory compliance, and quality assurance across the food, pharmaceutical, and environmental sectors—delivering reliable results with international standards and technical excellence.
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Get In Touch
At SIMA LABS, we’re proud to offer our expertise in analysis and research to help you find the right solutions.
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