Over the past decade, regulators and standard organisations have continued to tighten regulations governing pharmaceutical impurities, emphasising four key areas: extractables and leachables, mutagenic impurities, residual solvents and elemental impurities.
Risk-based controls and rigorous analytical detection ensure drug quality, efficacy and patient safety. However, tightening limits of detection and quantitation and the necessity for accuracy even with unknown or trace impurity levels can pose challenges for analytical labs. This raises questions about sample preparation and method development to ensure regulatory compliance. Even seasoned analysts may struggle to find reliable information.
Download the Agilent eBook, The Expert’s Guide to Pharmaceutical Impurity Analysis for:
- Quick information about the latest regulations
- Proven end-to-end workflows, including sample preparation, detection, analysis, and reporting
- New advanced technologies that can simplify analysis and exceed current testing requirements
CLICK HERE to download the eBook.
