In the last decade, the regulatory focus on pharmaceutical impurities has intensified, spotlighting four key areas: extractables and leachables, mutagenic impurities, residual solvents, and elemental impurities.
Risk-based controls and thorough analytical detection ensure drug quality, efficacy, and patient safety. However, stricter limits of detection and the need for accuracy, even with trace impurity levels, challenge analytical labs. Questions about sample preparation, method development, and compliance arise, often leaving even seasoned analysts in search of reliable information.
Download this eBook to discover:
- Tried-and-true analytical workflows for regulatory compliance
- Quick access to the latest regulations
- Methods to boost drug quality and safety
- Leading-edge technology to ease analyses
- And much more...
This distinct eBook, presented in a user-friendly widescreen format, facilitates easy navigation through its four chapters. Learning outcomes include:
Chapter 1: Extractables and Leachables
- Key drivers for analytical tool selection
- Prevalent impurities, their chemical nature, and sources
- Navigating the current E&L regulatory landscape
- Real-world examples of measuring extractables and leachables
Chapter 2: Mutagenic Impurities
- Rising threats of nitrosamine impurities
- Evolving regulations around mutagenic impurities
- Practical examples of nitrosamine detection using highly sensitive techniques, including triple quadrupole LC/MS
Chapter 3: Residual Solvents
- Why USP <467> offers two design options for compliance
- How modern analytical instruments ensure fast, accurate, and reproducible residual solvent analysis
- Technology to improve testing throughput
Chapter 4: Elemental Impurities
- Develop precise techniques for characterizing elemental impurities with inductively coupled plasma mass spectrometry
- Key updates in USP chapter <232>/<233>
- Risks of using outdated equipment to meet rigorous regulations
Elevate your lab's efficiency, uphold quality, and stay ahead in the ever-evolving pharmaceutical arena. Your journey towards mastering drug impurity analysis begins here.
To download your personal eBook of 'The Expert’s Guide to Pharmaceutical Impurity Analysis,' simply complete the form opposite.