Enhancing pharmaceutical analysis in critical areas

Dheeraj Handique, Manager GC/GCMS Product Marketing, Shimadzu Analytical (India) highlights the benefits of GCMS-TQ8050 NX with HS-20 NX trap for genotoxic impurities, nitrosamines, and, extractables and leachables

In the pharmaceutical industry, the detection and analysis of potentially harmful substances such as genotoxic impurities, nitrosamines, and, extractables and leachables (E&L) are crucial for ensuring drug safety and compliance with regulatory standards. The combination of the Shimadzu GCMSTQ8050 NX with the HS-20 NX Trap offers advanced analytical capabilities that address these challenges effectively. This article highlights how this powerful duo can enhance pharmaceutical analysis in these critical areas.

Understanding genotoxic impurities

Genotoxic impurities are substances that can damage genetic material, posing significant risks during drug development and manufacturing Regulatory agencies, such as the FDA and EMA, have established stringent guidelines for the acceptable levels of these impurities in pharmaceutical products. The GCMSTQ8050 NX, with its high sensitivity and specificity, enables accurate detection and quantification of genotoxic impurities in drug formulations.

Innovative solutions for nitrosamine detection