Handbook of Analytical Method Validation for Pharmaceuticals: A Practical Guide to Validating Assay, Impurities,...

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Bhaskar Napte

Handbook of Analytical Method Validation for Pharmaceuticals

A Practical Guide to Validating Assay, Impurities, Dissolution, and Residual Solvents Using...

Bhaskar Napte

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English

Blue Rose Publishers
15 September 2025

Medicine: general issues; Analytical chemistry

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.

By: Bhaskar Napte
Imprint: Blue Rose Publishers
Dimensions: Height: 229mm, Width: 152mm, Spine: 15mm
Weight: 358g
ISBN: 9789373108056
ISBN 10: 9373108050
Pages: 266
Publication Date: 15 September 2025
Audience: General/trade , ELT Advanced
Format: Paperback
Publisher's Status: Active

Bhaskar Napte is an industry expert with 20+ years of experience in analytical sciences, having worked with global pharma giants like Dr. Reddy's, Glenmark, USV, and Apotex. He now leads Pharma Growth Hub, where he trains and mentors professionals throughwebinars, coaching, and now, this practical book-crafted to empower the next generation ofpharma talent..