Title: Handbook of Analytical Method Validation for Pharmaceuticals : A Practical Guide to Validating Assay, Impurities, Dissolution, and Residual Solvents Using HPLC and GC
Publisher: Blue Rose Publishers Sep 2025
Publication Date: 2025
Language: English
ISBN 10: 9373108050
ISBN 13: 9789373108056
Binding: Taschenbuch
Condition: Neu
Dimensions: 229 millimeters width by 152 millimeters height by 15 millimeters depth
Weight: 358 grams

About this title

Synopsis

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.

About the Author

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..

"About this title" may belong to another edition of this title.

Store Description

Das Unternehmen AHA-BUCH GmbH: Seit der Gr�ndung von AHA-BUCH im Juli 2005 ist unser Hauptziel, zufriedenen Kunden so schnell und so preisg�nstig wie m�glich ihren B�cherwunsch zu erf�llen. Unsere Firma besch�ftigt 16 Mitarbeiter, die nur ein Ziel kennen: den Kunden und seine W�nsche! Auf �ber 3700 m2 Fl�che haben wir �ber 100.000 B�cher, Modernes Antiquariat und Spiele auf Lager.

Visit Seller's Storefront

Seller's business information

AHA-BUCH GmbH
Garlebsen 48, Einbeck, 37574, Germany

Sale & Shipping Terms

Terms of Sale

General Terms and Conditions and Customer Information / Privacy Policy

I. General Terms and Conditions

� 1 Basic provisions

(1) The following terms and conditions apply to all contracts that you conclude with us as a provider (AHA-BUCH GmbH) via the Internet platforms AbeBooks and/or ZVAB. Unless otherwise agreed, the inclusion of any of your own terms and conditions used by you will be objected to

(2) A consumer within the meaning of the following regulations is any natural person who concludes...

More Information

Shipping Terms

We ship your order after we received them
for articles on hand latest 24 hours,
for articles with overnight supply latest 48 hours.
In case we need to order an article from our supplier our dispatch time depends on the reception date of the articles, but the articles will be shipped on the same day.

Our goal is to send the ordered articles in the fastest, but also most efficient and secure way to our customers.

Shipping rates from Germany to U.S.A.

Shipping rates from Germany to U.S.A.
Order quantity	30 to 40 business days	7 to 14 business days
First item	US$ 71.49	US$ 83.06

Delivery times are set by sellers and vary by carrier and location. Orders passing through Customs may face delays and buyers are responsible for any associated duties or fees. Sellers may contact you regarding additional charges to cover any increased costs to ship your items.