It is imperative that manufacturers understand the possible source of nitrosamine formation in their manufacturing process and add proper controls to reduce the possibility of formation of these carcinogenic impurities.
Analytical Testing Service
Nitrosamine and Genotoxic Impurity Analysis
At Scitus, we have considerable expertise in method development and validation of nitrosamines, genotoxic impurities and optimizing extraction procedures that allow us to apply these methods to drug products and active pharmaceutical ingredients (APIs) using Shimadzhu 8060NX UHPLC-MS/MS.
We have considerable expertise for development and validation of methods for quantification of elements in biological matrices, bone, hair etc., by following GLP and regulatory guidance using Agilent 7850 ICPMS. ICP-MS (Inductively Coupled Plasma Mass Spectrometry) methods of analysis are being used to quantify the concentration of elements contained in pharmaceutical compounds.