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:
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.