OLON API’s Nitrosamine confirmatory test
The analyses of nitrosamines are challenging. Ultralow levels of these impurities must be quantified in diverse and complex matrices. The developed methods then need to be validated to conform to GMP requirements.
OLON is internally equipped with the required equipment to meet these limits, including Thermo Scientific™ Q Exactive™ Hybrid Quadrupole-Orbitrap Mass Spectrometer.
We have experience with nitrosamine testing, including validating quantitative and test limit methods for our APIs, as well as screening testing methods.
We can provide both toxicological and analytical support for risk evaluation using also third parties qualified suppliers.