Nitrosoamines
In Lunaria 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).
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LC/MS testing

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GC/MS testing

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

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Lenka Zlatníčková

Head of QC and R&D

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lenka.zlatnickova@lunaria.cz