SGS Develops Nitrosamine Test Method to Identify NDMA in Drugs
In response to the identification of N-nitrosodimethylamine (NDMA), a potential carcinogen, in drug products by the US Food & Drug Administration (US FDA) and European Medicines Agency (EMA), SGS has developed a test method to identify NDMA traces in drug products.
SGS has developed a test method, based on LC-MS, to detect the presence of N-nitrosodimethylamine (NDMA) traces in drug products, raw materials and active pharmaceutical ingredients (APIs), at even the lowest levels.
The US Environmental Protection Agency (EPA) is recommending that all manufacturers and providers test their products to protect patients and ensure that effective measures are taken to prevent these impurities from being present in medicines.
Available globally, through a global network of Life Sciences testing laboratories, our test method will:
- Identify NDMA traces in drug products, raw materials and active pharmaceutical ingredients (APIs)
- Protect patients
- Ensure regulatory compliance
What is NDMA?
NDMA is a semi-volatile organic chemical, a nitrosamine impurity that is produced as a by-product of several industrial process. It is also present at very low levels in water and foods. Identified as a potential carcinogen, NDMA is also toxic to the liver and other organs.
SGS NDMA Testing Services
Assure the safety of drug products, employ our expertise to verify the status of your products and protect patients. With fast turnaround times and the most effective test method currently on the market, you can trust SGS to quickly and efficiently identify any issues, enabling you to take remedial action swiftly.
For further information, please contact:
Director Analytical Operations, SGS
t: +1 905 364 3757 x13751
SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 97,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.