Handbook of Analytical Method Validation for Pharmaceuticals

Bhaskar Napte

• 15 september 2025
• 9789373108056

Samenvatting:

Handbook of Analytical Method Validation for Pharmaceuticals- A practical guide to validating assay, impurities, dissolution, and residual solvents usingHPLC and GCDesigned for pharmaceutical professionals, this practical handbook serves as a step-by-stepguide to mastering analytical method validation. Covering key parameters such as assay, related substances, dissolution, and residual solvents, the book provides clear insights onusing 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 conceptswith real-world examples, easy-to-follow protocols, and best practices drawn from decades ofindustry experience.What You'll Learn: 1. How to validate analytical methods for various pharmaceutical tests2. Step-by-step guidance on selecting performance characteristics3. Practical tips for setting concentration levels and preparing validation protocols4. How to conduct forced degradation studiesThis book is a must-have resource for professionals working in quality control, analyticalR&D, and regulatory affairs.