Methods for Stability Testing of Pharmaceuticals

This detailed volume collects numerous methods and protocols related to different aspects of stability programs that are followed in pharmaceutical development laboratories. Implementation of a successful stability program, vital in preventing product fai

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Sanjay Bajaj Saranjit Singh Editors

Methods for Stability Testing of Pharmaceuticals

METHODS

IN

PHARMACOLOGY

TOXICOLOGY

Series Editor Y. James Kang Department of Pharmacology & Toxicology University of Louisville Louisville, Kentucky, USA

For further volumes: http://www.springer.com/series/7653

AND

Methods for Stability Testing of Pharmaceuticals Edited by

Sanjay Bajaj Select Biosciences India Private Limited, Chandigarh, India

Saranjit Singh Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Mohali, Punjab, India

Editors Saranjit Singh Sanjay Bajaj Select Biosciences India Private Limited Department of Pharmaceutical Analysis National Institute of Pharmaceutical Education Chandigarh, India and Research (NIPER) Mohali, Punjab, India

ISSN 1557-2153 ISSN 1940-6053 (electronic) Methods in Pharmacology and Toxicology ISBN 978-1-4939-7685-0 ISBN 978-1-4939-7686-7 (eBook) https://doi.org/10.1007/978-1-4939-7686-7 Library of Congress Control Number: 2018933594 © Springer Science+Business Media, LLC, part of Springer Nature 2018 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, express or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Printed on acid-free paper This Humana Press imprint is published by the registered company Springer Science+Business Media, LLC part of Springer Nature. The registered company address is: 233 Spring Street, New York, NY 10013, U.S.A.

Preface We, as pharmaceutical scientists, have always seen stability testing as a vital part of any drug development process. From the very basic level of experimentation, like stability of suspensions and emulsions in undergraduate laboratory, to stability testing of active pharmaceutical ingredients and conventional products containing them, and further to highly technical novel drug delivery systems, a thorough investigation on stability of every kind of product is desired for the benefit