AMPAC Analytical has implemented test methods using LC-HRMS and GC-MS to identify trace Nitrosamines in drug substances and drug products.

Stay in compliance with the FDA, get your active pharmaceutical ingredient (API) and drug product tested for NDMA.

Test for NDMA today

NDMA and Nitrosamines are difficult molecules to detect

General analytical tests previously used by the industry for the release of API/DP may not have been able to detect the presence of Nitrosamines. AMPAC Analytical Labs has implemented methodologies to detect this class of impurities using LC-HRMS as well as GC-MS.

Why Test For NDMA Impurities

NDMA and Nitrosamines in general are genotoxic impurities and have been classified by the U.S. Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) as a probable human carcinogen. Nitrosamines, such as N-Nitrosodimethylamine (NDMA), can be found at low levels in numerous items of human consumption, including cured meat, fish, beer, tobacco smoke and most recently as an impurity in various pharmaceuticals.

In recent reports, there have been several Angiotensin-II-receptor antagonists, AKA “Sartans”, which have been contaminated with NDMA. The EPA has determined that the maximal admissible concentration of NDMA in drinking water is 7 ng/L.

Test Your Products in Compliance For FDA Guidelines

Pharmaceutical products have been on the news as these products are taken for chronic diseases; medications taken multiple times a day and in varying dosages. Regulatory agencies are actively involved in addressing the issue with detection, testing and quantitation of these impurities. New applications, renewal, synthetic route modifications and sourcing of material modifications can be subject of evaluation for the presence of Nitrosamines.

Learn More About Genotoxic Impurities

Watch our Webinar

N-Nitrosodimethylamine (NDMA) is a yellow, oily liquid with a faint, characteristic odor. It is an industrial by-product or waste product of several industrial processes, such as manufacturing of unsymmetrical dimethylhydrazine, which is a component of rocket fuel that requires NDMA for its synthesis. NDMA is found at low levels in numerous items of human consumption, including cured meat, fish, beer, tobacco smoke and most recently as an impurity in various pharmaceuticals. In recent reports there have been several “sartans” that have been contaminated with NDMA, which is highly toxic, especially to the liver, and is a known carcinogen in lab animals. The EPA classifies NDMA as a probable human carcinogen. The US Environmental Protection Agency has determined that the maximal admissible concentration of NDMA in drinking water is 7 ng/L.

Nitrosamine impurities such as NDMA and NDEA can be analyzed and quantified using gas chromatography or high performance liquid chromatography coupled with an high-resolution mass spectrometer.

Nitrosamine impurities such as NDMA and NDEA can be quantified using gas chromatography or high performance liquid chromatography coupled with an high-resolution mass spectrometer.

Nitrosamine impurities such as NDMA and NDEA can be detected at ppb level using gas chromatography coupled with an high-resolution mass spectrometer.

Nitrosamine impurities such as NDMA and NDEA can be analyzed and quantified using gas chromatography or high performance liquid chromatography coupled with an high-resolution mass spectrometer.

Nitrosamines are a family of carcinogens impurities which are formed by the reaction of secondary amines, amides, carbamates, derivatives of urea with nitrite or other nitrogenous agents. Nitrosamines are classified by the ICH M7 Guideline as Class 1 impurities also known as mutagenic carcinogens.

  • Use of sodium nitrite (NaNO2), or other nitrosating agents.
  • Use of contaminated raw materials and intermediates by nitrosamine.
  • Degradation processes of starting materials, intermediates and drug substances. This could potentially occur also during finished product formulation or storage.
  • Use of certain contaminated packaging materials