MilliporeSigma

In Nitrosamine Testing, Our Quality Protects Yours


Nitrosamines in Pharmaceuticals

The pharmaceutical industry heightened its concern about nitrosamines, particularly N-nitrosodimethylamine (NDMA), after its discovery in valsartan in July 2018. This triggered recall of angiotensin II receptor blocker medications, leading to increased scrutiny for nitrosamine impurities in drug products. Multiple factors, including degradation processes, contaminated raw materials, solvents, and reagents, contribute to the presence of these "unintended" organic impurities in pharmaceuticals.

Classified as Class 1 impurities, these N-nitrosamines are designated as "cohort of concern" compounds and "known mutagenic carcinogens" by the ICH Guideline M7(R1). Additionally, they are classified as 2A–Probable Carcinogens by the International Agency for Cancer Research (IARC), highlighting the critical need for rigorous nitrosamines analysis in the pharmaceutical industry.

The FDA’s list of nitrosamine impurities, including NDMA, NDEA (N-nitrosodiethylamine), NIEPA, NDIPA, NDBA (N-nitrosodibutylamine), and NMBA, highlights NDMA and NDEA as the most prevalent nitrosamines in drugs. Current regulatory restrictions allow only very low levels, requiring highly sensitive analytical techniques for nitrosamine detection.

We offer a comprehensive portfolio of nitrosamine testing products, supported by detailed application guidelines, ensuring reliable detection of these carcinogenic nitrosamines using LC-MS or GC-MS methodologies.


Nitrosamine Analysis Workflow

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Sample Preparation

Explore our comprehensive range of sample prep solutions for an accurate nitrosamine analysis.

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Standardization & Calibration

High-quality reference standards to ensure precise, consistent, and reliable test results in nitrosamines analysis of drug products.

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HPLC/GC Analysis

Premium-grade HPLC/GC columns and accessories, meticulously designed to facilitate the precise separation of API peaks and nitrosamines.


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Features & Benefits:

  • Unrivaled accuracy using certified nitrosamines standards.
  • Enhanced performance through cutting-edge GC and HPLC columns.
  • Precise analyses facilitated by our products' unparalleled sensitivity.
  • Thorough analysis with comprehensive nitrosamine coverage from NDMA to NDBA.
  • Seamless compatibility with your preferred techniques.
  • Consistent, reproducible results maintained throughout analyses.
  • Regulatory guideline adherence ensured with compliant products.

Explore our complete nitrosamine testing solutions, for sample prep, standardization, and analysis to guarantee the safety and quality of your pharmaceutical products.


Related Webinars

The poster features a purple cell in the center containing the title of the webinar: "Analysis of nitrosamines in drugs using chromatographic methods according to regulatory requirements." The text is written in sky blue color, providing a striking contrast against the purple background.  To the left of the purple cell, there is a yellow cell displaying a strip of tablets, representing pharmaceutical products. On the right side of the purple cell, there is another yellow cell featuring a vibrant "M" logo, representing the webinar host or sponsor.

Impurity testing: Nitrosamine impurity analysis using GC-MS & LC-MS

Discover the essentials of nitrosamine impurity analysis using GC-MS & LC-MS following the regulatory requirements.

Watch Webinar
The poster features a split background with one half green and the other half yellow. In the center, the title of the webinar, "Overview on determination of nitrosamines in drug products," is written in bold purple font. Below the title, also in purple, is the name of the presenter: Dr. Frank Michael.
Overview on determination of nitrosamines in drug products

The webinar will touch on the top key applications according to pharmacopoeia requirements that every Pharma QC lab runs.

Watch Webinar
Poster image for the webinar titled 'Analytical Testing of Nitrosamines in Drugs and Food' by LCGC
Analytical Testing of Nitrosamines in Drugs and Food


Explore the latest advancements and regulatory requirements in detecting nitrosamines, crucial contaminants in pharmaceuticals and food products.

Watch Webinar


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