Nitrosamine Testing

We are now testing pharmaceutical materials for nitrosamines, with methods established for critical small molecule nitrosamines and the capability to test for ingredient specific larger molecule nitrosamines (NDSRIs).

Chemika is now offering this as a service to our clients following the commissioning of a Shimadzu LCMS 8060NX triple quadrupole mass spectrometer and several months of qualification and development work. All testing will be carried out at our Sydney laboratory, accelerating time lines and allowing for real time updates on progress.

With more than 25 years of experience in method validation for the pharmaceutical industry, Chemika is highly skilled in implementing validation protocols tailored to your specific needs. We are happy to collaborate with you to design a testing regime that meets the requirements of the TGA and overseas regulatory agencies for the control of nitrosamines.