Auriga Research provides end-to-end nitrosamine impurity testing powered by high-resolution LC-MS/MS & GC-MS/MS platforms and NABL-accredited, DCGI-approved laboratory infrastructure. Our expertise enables pharmaceutical organizations to safeguard product quality, mitigate risk, and ensure seamless compliance with evolving regulatory mandates.
Nitrosamine Drug Substance-Related Impurities (NDSRIs) such as NDMA, NDEA, NMBA, NMPA, and others are classified as probable human carcinogens. Even at micro-trace levels, they pose a significant patient-safety concern and can trigger large-scale recalls, regulatory warnings, and market disruptions.
Global regulators including USFDA, EMA, EDQM, MHRA, WHO, and DCGI now mandate:
Most laboratories lack the instrumentation, validated methods, or expertise to detect genotoxins at such low levels. Auriga’s LC-MS/MS platforms bridge this gap with pharmaceutical-grade precision.
Ultra-trace detection capability for a comprehensive panel including
NDMA | NDEA | NDIPA |
NEIPA | NDBA | NMPA |
NMBA | NDELA | Other |
We quantify nitrosamines at levels aligned with global acceptable daily intake criteria.
Our analytical workflows are designed to meet:
We execute targeted nitrosamine impurity investigations for:
Auriga’s upgraded LC-MS/MS & GC-MS/MS ecosystem delivers:
Auriga Labs are USFDA approved, ensuring your pharmaceutical products meet the highest international safety and regulatory standards through our advanced testing and analysis services.
Auriga Labs are CDSCO approved, ensuring compliance with Indian regulatory standards. Trust our advanced testing services for safe, high-quality pharmaceutical products.
Our laboratories are accredited by the National Accreditation Board for Testing and Calibration Laboratories (NABL), ensuring the highest standards of quality and reliability.
Detection of multiple impurities including nitrosamines and NDSRIs using advanced methods.
All tests are conducted in USFDA-approved labs, assuring regulatory compliance and quality.
Affordable pricing ensures high-quality, compliant testing without breaking your budget.
Expert teams with years of experience in impurity analysis and regulatory compliance.
”Auriga Research Labs ensure our pharmaceutical safety with their advanced testing. Their expertise, LC-MS/MS technology, and quick turnaround times provide us with unmatched confidence in our product quality.”
Sunil Kumar Choudhary
”Partnering with Auriga Research Labs ensures reliable testing. Their NABL accreditation, ISO/IEC 17025 certification, and detailed reports streamline our regulatory submissions. Exceptional service and support!”
Neha Yadav
”Auriga Research Labs' precise NDMA and genotoxin detection maintains our product safety. Their excellence and customer-focused approach make them our trusted lab for all testing needs.”
Abhinav Sharma
We utilize advanced LC-MS/MS technology to detect NDMA and other nitrosamines in pharmaceuticals, ensuring they meet safety and regulatory standards. Our precise testing identifies even trace amounts, safeguarding your products and protecting consumer health.
Nitrosamine testing detects harmful impurities like NDMA in pharmaceuticals. It's crucial for ensuring product safety, regulatory compliance, and protecting public health.
Our lab tests for various nitrosamines, including NDMA, NDEA, NEIPA, and more, using advanced LC-MS/MS technology to detect even trace amounts.
Auriga Labs can test for a wide range of Nitrosamines and genotoxic impurities, including NDMA, Chloroacetonitrile, 2-Bromo aniline, Methane sulfonic acid, Methyl Methane Sulfonate, and many others. A complete list includes more than 20 different impurities with acceptable limits provided.
Absolutely. We offer tailored testing solutions to meet your specific needs and regulatory requirements, ensuring your products' safety and compliance.
Take the first step towards ensuring the safety and compliance of your pharmaceutical products. Reach out to Auriga Research Lab to learn more about our testing services and how we can assist you.
