Nitrosamine and Genotoxic Impurity Testing

SK pharmteco has implemented test methods using LC-HRMS and GC-MS to identify trace Nitrosamines, Nitrosamine Drug Substance-Related Impurities (NDSRIs), and other genotoxic impurities in both drug substances and drug products.

Stay compliant with the FDA and get your active pharmaceutical ingredient (API) and drug product tested for genotoxic impurities.

NDMA & Nitrosamines: Difficult to Detect

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

Why Test For Nitrosamines?

Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have issued guidelines and recommendations for the pharmaceutical industry to address the presence of nitrosamines in drug products. These guidelines include conducting risk assessments, implementing appropriate manufacturing controls, and performing routine testing to detect and quantify nitrosamines in pharmaceuticals. 

SK  pharmteco has extensive experience for control of nitrosamines and NDSRIs across a variety of modalities for drug substance and drug products. The guidance for nitrosamine impurities issued by the FDA and EMA specifies very low limits for the typical nitroso impurities individually. When there is the risk of more than one nitrosamine present, the total nitrosamines must be no more than the limit for the lowest acceptable intake, often in the low part per billion (ppb) range.


To view the FDA’s “Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities” (NDSRIs) PDF document, please click the link below.

Test Your Products to Comply with
FDA Guidelines

Pharmaceutical products found to contain nitrosamines and other genotoxic impurities have been in 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 by detecting, testing, and quantifying these impurities. New applications, renewal, synthetic route modifications, and sourcing of material modifications can be subject to evaluation for the presence of Nitrosamines and NDSRIs.

To view the FDA’s “Control of Nitrosamine Impurities in Human Drugs – Guidance for Industry” PDF document, please click the link below.

We Offer Speed, Accuracy, Expertise - and Piece of Mind

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

SK pharmteco offers:

  • Rapid Turnaround –  Screening available within 72 hours
  • Detection Limits: 1 ppb or lower
  • Specialized Techniques: LC-MS, GC-MS, High Resolution Mass Spec, LC-QQQ
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