Overview of Nitrosamine Impurity Testing
- Tested by
- NABL-accredited partner lab
- Regulation
- FDA, EMA & CDSCO guidance
- Typical turnaround
- 7–15 working days
- Sample needed
- Batch samples and reference
Nitrosamines are probable human carcinogens. Since NDMA was found in valsartan in 2018, and later in ranitidine and metformin, regulators in the US, Europe and elsewhere have required manufacturers to assess every product for nitrosamine risk and to test where a risk is found. Limits are set as acceptable daily intakes in nanograms, so methods must detect parts-per-billion levels.
The newer concern is nitrosamine drug substance-related impurities (NDSRIs), which form from the API itself when it contains a secondary or tertiary amine and meets nitrite from excipients or water. Testing uses LC-MS/MS or GC-MS/MS with methods developed and validated for each product, often alongside a review of nitrite levels in excipients.
What we do for you
- Lab and parameter list chosen for your purpose: licence, export, buyer or internal QC
- Sampling guidance, and pickup or on-site sampling where needed
- One contact who follows up with the lab until the report is issued
- Report explained in plain language, with next steps if a result fails