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.
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.
The TripleTOF™ 5600+ and ImpurityPilot™ software allows you to accomplish:
Table 1. Classification of impurities detected in pharmaceutical drug development and production.
|Organic Impurities||Inorganic Impurities||Residual Solvents||Genotoxic Impurities|
Heavy metals/other residual metals
Other materials (e.g., filter aids, charcoal)
Class 1: Solvents to be avoided - Benzene
Class II: Solvents to be limited-ACN
Class III: Solvents with low toxic potential - Acetone
Potential to damage DNA
Potential to cause cancer
Need to be controlled at lower levels