Headspace-GCMS Solution for Analysis of Nitrosamines Impurities
This video present you a solution from Shimadzu for to analyse nitrosamines impurities using headspace with GCMS. Nitrosamines have become the topic of focus in today's pharmaceutical industry ever since US FDA detected them in Sartan drugs back in 2018, thus triggering voluntary product recalls in several companies. Nitrosamines are considered as Potential Genotoxic Impurities (PGIs), which may be teratogenic, mutagenic, and/or carcinogenic. These impurities can be formed due to the processing of active pharmaceutical ingredients (APIs) under certain processing conditions or when excipients are added. Therefore, during the drug manufacturing process, from synthesis, purification, formulation to packaging and storage of the product, a highly sensitive instrument such as GC-MS/MS is required to monitor the presence of nitrosamine impurities. In this aspect, Shimadzu recommends the use of GCMS-TQ8050 NX with the HS-20 NX headspace sampler for nitrosamine analysis. Equipped with Ultra-Fast Mass Spectrometry (UFMS) capabilities, (show UFMS logo) our instrument is a proven solution to analyze impurities such as NDMA and NDEA. With best-in-class sensitivity and easy usability, we are confident that you'll be able to experience exceptional productivity in monitoring nitrosamines for quality control. Furthermore, our workflow solution also offers minimal sample preparation. All you need to do is simply weigh the sample, then add the organic solvent into the headspace vial, and you can start the analysis! Such simple and straightforward sample preparation, combined with our HS-GCMS solution, offers a productive approach for the pharmaceutical labs to perform high throughput analysis.
