Download this free e-book from Shimadzu to discover how you can quantify trace levels of nitrosamine impurities from various drug substances, drug products and solvents using ultra-fast mass spectrometry technologies.
The presence of potentially carcinogenic nitrosamines (NO+) in drug products must be monitored to avoid significant quantities building up during the manufacturing process.
It is believed that nitrosamines can be sourced from packaging, solvents/water, excipients and may even form during storage.
By utilising Shimadzu’s ultra-fast mass spectrometry technology with analytical intelligence, in either gas or liquid chromatography modes, industrial standards can easily be met to identify and quantify a range of nitrosamine drug impurities.
These rugged and sensitive systems can offer LOQ levels of approximately 2 ppb for some applications, with linearity assessed from as low as 0.1 ppb. In addition, analytical intelligence improves the efficiency of the entire workflow and maximises laboratory throughput.
The e-book also contains sartan, metformin, residual solvent and other API analyses. Download your free copy today!