Genotoxic Impurities in
Pharmaceuticals Summit 2019
GTI strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities.
- 11 Apr 2019
- Berlin, DE
- Pharma
Day 1: Thursday, 11 April 2019
CASE STUDY: Characterization and quantitation of genotoxic impurities using a single platform. The Valsartan case.
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.
The Valsartan case, has shown the need for the implementation of the state of the art technology in the QC/QA laboratories. A creation of 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 to increase the safety of the end product. This critical information speeds drug candidate development from IND-enabling studies to NDA.
In our presentation we show how the combination of the speed, sensitivity and resolution on the latest QTOF technology can help to solve the questions related to the characterization and quantiation of impurities, with a system and solution that:
- Is able to support all workflows to be used in impurity analysis: from impurity profiling to quality control.
- Comes along with all Pharma QC requirements: 21 CFR Part 11 compliance, MS/MSALL SWATHTM, high-resolution mass accuracy, reproducibility and sensitivity to detect smallest traces of impurities.
- Works in a General Unknown Comparative Screening method easy-to-use, considered the ‘Gold-Standard’ workflow in Pharma quality control analysis. It shows significant strengths to monitor batch-to-batch production of active medicinal components.
- Includes Statistical analysis for either in-depth impurity analysis or to obtain information about the origin of active medicinal component.
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