Nitrosamine Detection: meet EMA and FDA regulations

In 2018, the presence of the nitrosamine N-nitrosodimethylamine (NDMA), a potential carcinogen, in certain sartan active pharmaceutical ingredients (APIs) resulted in several regulatory warnings and recalls of contaminated products.

Concerns over the presence of this class of genotoxins has since widened to include other medicines, such as the well-known diabetes drug Metformin, and Ranitidine, which is used to treat heartburn and stomach ulcers.

In September 2019, the EMA and other regulatory authorities instructed all pharmaceutical manufacturers to conduct a risk assessment and proactively test their products to protect patients and ensure that effective measures are taken to prevent the presence of nitrosamine impurities in human medicines by the end of March 2020.

Marketing authorisation holders will then have until September 26, 2022 to perform further confirmatory testing on the products identified to be at risk of N-nitrosamine formation or (cross-)contamination and take mitigation measures where risks are identified, starting with the highest risk products.

SGS has developed a test method to identify nitrosamine impurities in drug products to help drug sponsors ensure product safety. The test method, based on LC-MS, detects the presence of NDMA traces in drug products, raw materials and APIs, at even the lowest levels. Central to these activities is a coordinated analytical capability to identify and quantify contaminants across global geographies and regulatory zones.

Available globally, through a global network of Life Sciences testing laboratories, our test method will:

  • Identify NDMA traces in drug products, raw materials and APIs
  • Protect patients
  • Ensure regulatory compliance

SGS leverages its digitalised network of Life Sciences laboratories, present in North America, Europe, and Asia-Pacific, to deliver harmonised testing solutions for analytical development, biologics characterisation, biosafety and quality control, as well as clinical research to large pharmaceutical and biotechnology firms.

Featured Companies

SGS Life Sciences (more information, website)