Nitrosamine Impurity Analysis is critical to address the purity, safety and quality of drug substances or finished drug products. These impurities can cause DNA mutation, chromosome damage or DNA recombination even at a very low concentration. Regulatory agencies such as FDA, EMEA, ICH, USP, CFDA have issued relevant guidelines, clearly stipulated the limits of nitrosamine impurities. Identifying GIs early in the drug development process and/or limiting nitrosamine impurities at acceptable levels in the API or drug product, can avoid risks associated with drug safety and quality later in development.

VitelyBio’s GCP/GLP/GMP compliant laboratory & subject matter expertise provide Nitrosamine Impurity testing services to detect and evaluate the potential of GIs for your API and/or drug substances which can support your product development from an early stage to market release. We can provide method development and validation of suitable analytical procedures to overcome the challenges of low detection levels and difficult matrices.

Our comprehensive characterisation techniques include:

High Performance Liquid Chromatography with (HPLC with UV/Vis detectors)

Gas Chromatography (GC) and GC-MS

Liquid Chromatography-Mass Spectrometry (LC-MS)

Inductively- Coupled Plasma Mass Spectrometry (ICP-MS)