Search >>
Announcement Details
Contact UsNitrosoamines
In Eurofins BioPharma Product Testing Czech Republic s.r.o. we are equipped with GC/MS instrument (Thermo Scientific TRACE 1310 with mass detector TSQ 9000). We use this instrument for both R&D and QC (GMP) analysis (the system is fully qualified).
Within the implementation of this instrument we set up the method for nitrosoamines determination (in Metformin tablets) with following detection limits:
| LOD | LOQ | |||
| ng·mL-1 | ppb (wrt formulation) |
ng·mL-1 | ppb (wrt formulation) |
|
| N-nitrosodimethylamine (NDMA) | 0.1 | 1 | 0.5 | 5 |
| N-nitrosodipropylamine (NDPA) | 0.1 | 1 | 0.3 | 3 |
| Diethylnitrosoamine (NDEA) | 0.1 | 1 | 0.3 | 3 |
| 1-nitrosopiperidine (NPIP) | 0.1 | 1 | 0.5 | 5 |
| N-nitroso-N-methylethylamine (NMEA) | 0.05 | 0.5 | 0.2 | 2 |
| N-nitroso-n-butylamine (NDBA) | 0.03 | 0.3 | 0.1 | 1 |
| 1-nitrosopyrrolidine (NPYR) | 0.3 | 3 | 0.8 | 8 |
We are also performing the analyses of nitrosoamines (NDMA) using the LC/MS instrument (Dionex UltiMate 3000 coupled with Q Exactive Quadrupole Orbitrap Mass Spectrometer from Thermo Scientific). The detection limits are:
| LOD | LOQ | |||
| ng·mL-1 | ppb (wrt formulation) |
ng·mL-1 | ppb (wrt formulation) |
|
| N-nitrosodimethylamine (NDMA) | 0.65 | 1.3 | 1.7 | 0.02 |
Contact Us