Nitrosamines and impurities

LC-MS/MS methods are nowadays commonly used for nitrosamines analysis in all types of materials, since it allows analyte-specific detection based on both retention time and structurally specific fragmentation information in conjunction with high sensitivity.

After the establishment of the nitrosamines limits, the quantification limit of QPLAB´s method can be adapted to the product under analysis, ensuring that the method has the necessary sensitivity to control the impurity content.

QPLab has in-house methods to determine nitrosamines based on the acceptable intake (AI) of each nitrosamine:

• NDMA (62-75-9) – 96.0 ng/day
• NDEA (55-18-5) – 26.5 ng/day
• NMBA (61445-55-4) – 96.0 ng/day
• NEIPA (16339-04-1) – 26.5 ng/day
• NDIPA (601-77-4) – 26.5 ng/day
• NMPZ (16339-07-4) – 26.5 ng/day
• NMPA (614-00-6) – 34.3 ng/day
• NDBA (924-16-3) – 26.5 ng/day
• NDPA (621-64-7) – 26.5 ng/day
• NMOR (59-89-2) 127.0  ng/day
• NNV – 37.0  ng/day

Validation of a quantification method

The validation of a quantitative method for the determination of N-nitrosamines impurities in drug products will be carried out according to ICH guidelines.

Routine QC analysis

Routine analysis of each sample / batch will be performed according to the validated method.