The screening test consists in the assessment of which nitrosamines are present in the drug product below an acceptable limit, defined according to the recommendations of EMA.
These limits are calculated based on the acceptable intake (AI) of each nitrosamine. QPLAB has a LC-MS/MS method that includes up to 10 nitrosamines to a detection limit between 5-10 ppb.
Nitrosamine / AI (ng/day)