Shimadzu Solutions for Nitrosamine Analysis in Pharmaceuticals

Detection and determination of nitrosamine impurities in drug manufacturing processes have become very critical in the pharmaceutical industry. In recent years, some manufacturers have recalled certain drugs as a precautionary measure after nitrosamine impurities were found in some drugs. Nitrosamines are categorized by the International Agency for Cancer Research (IARC) as 2A – Probable Carcinogens.

Because of the physicochemical properties of nitrosamines, such as low molecular weights, volatility, and high toxicity, analytical methods for nitrosamines require specificity, excellent chromatographic separation, and extremely sensitive detection capability.

Shimadzu presents various analytical methods for quantitative determination of nitrosamine compounds in drugs and solvents. These methods are developed with reference to methods published by international organizations such as the US FDA and use gas chromatography mass spectrometry (GC-MS and GC-MS/MS) and liquid chromatography mass spectrometry (LC-MS/MS) approach.

Join us for this webinar to know more about these analytical methods and find out how Shimadzu can meet your nitrosamines analysis needs.

Presenter: Tuna Oncu (Assistant Manager, Shimadzu Middle East & Africa)