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 Service
Nitrosamine and Genotoxic Impurity Analysis
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, active pharmaceutical ingredients (APIs) and raw materials using UFLC-MS/MS.
Elemental Analysis
We have considerable expertise scientist for development and validation of methods for quantification of elements in biological metrics, bone, hair, drug substance, excipients etc., by following GLP and regulatory guidance. ICP-MS (Inductively Coupled Plasma Mass Spectrometry) methods of analysis are being used to quantify the concentration of elements contained in pharmaceutical compounds.
