Following the evidence of health-threatening nitrosamines in pharmaceutical products, the EMA requires pharmaceuticals to be tested for nitrosamine contaminations. We offer the analysis of active pharmaceutical ingredients (API), excipients or finished products for nitrosamines under GMP or GLP conditions.
Our wide range of methods for the analysis of nitrosamines includes highly sensitive techniques such as LC-MS/MS, GC-MS/MS and HS-GC-MS/MS to ensure the high requirements for selectivity and sensitivity.
The following nitrosamines are established in our laboratory and can be quantified on demand:
- N-Nitroso-dimethylamine (NDMA)
- N-Nitroso-ethylmethylamine (NMEA)
- N-nitroso-diethylamine (NDEA)
- N-Nitroso-ethyl-isopropylamine (EIPNA)
- N-Nitroso-di-isopropylamine (DIPNA)
- N-Nitroso-di-n-propylamine (DNPNA)
- N-nitroso-di-butylamine (DBNA)
- N-Nitroso-N-methylaniline (NMAn)
- N-Nitroso-N-methyl-4-amino-butyric acid (NMBA)
We are pleased to determine additional nitrosamines upon request after individual method adjustments.
The scope of the product-specific validation will be defined in consultation with you. We are happy to take your specifications into account when preparing the validation protocol and the validation report.