For Research Use Only; Not for use in diagnostics.
To ensure patient safety regulatory agencies have put in place guidelines which mandate the identification and profiling of impurities in APIs and formulated drug products and sets thresholds at which these impurities must be reported. A fast, high throughput, robust, and reproducible analytical technology and method (e.g., LC-MS) is critical for increased confidence in impurity identification, detection, and quantification in pharma research. This critical information speeds drug candidate development from IND-enabling studies to NDA.
Identify, Characterize, Quantify
Achieve powerful results in impurity identification, characterization, and quantification with the SCIEX TripleTOF™ 5600+ System and the powerful ImpurityPilot™ software data analysis tool, as an optimized combination of accurate mass spectrometry and easy to use software. In every step of the impurity profiling workflow from data acquisition, identification and characterization of impurities, to batch-to-batch comparison, and quantification of impurities, the SCIEX solution assists scientists.