Handbook of Analytical Method Validation for Pharmaceuticals
- A practical guide to validating assay, impurities, dissolution, and residual solvents using
HPLC and GC
Designed for pharmaceutical professionals, this practical handbook serves as a step-by-step
guide to mastering analytical method validation. Covering key parameters such as assay,
related substances, dissolution, and residual solvents, the book provides clear insights on
using HPLC and GC techniques in compliance with regulatory expectations.
Whether you are validating a method for the first time or looking to deepen your expertise,
this guide bridges the gap between theory and application. It simplifies complex concepts
with real-world examples, easy-to-follow protocols, and best practices drawn from decades of
industry experience.
What You'll Learn:
1. How to validate analytical methods for various pharmaceutical tests
2. Step-by-step guidance on selecting performance characteristics
3. Practical tips for setting concentration levels and preparing validation protocols
4. How to conduct forced degradation studies
This book is a must-have resource for professionals working in quality control, analytical
R&D, and regulatory affairs.
