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Quantitative and Qualitative
Determination Technologies of
Counterfeit Drugs
Drugs are often counterfeited to reduce manufacture costs, while still marketing
it at as an authentic product. Increased incidence of drug counterfeiting is most
noticeable in developing countries, which may not have the resources to supply
counterfeit detection devices on a large scale. It is important to consider the
problems caused and to propose options for controlling and reducing the prevalence
of counterfeit medications. Various technologies are needed to identify the chemical
properties of a questioned medicinal product, which can then be used to determine
its authenticity. This volume focuses on current technological approaches that are
able to detect counterfeited pharmaceuticals.
Features
• Focuses on current technological approaches that are able to detect
counterfeited pharmaceuticals.
• Assesses the chemical methods of identifying counterfeit medicinal products
and explains the theoretical underpinnings of the methods.
• Provides case study type examples of the application for analysis of suspected
counterfeit pharmaceuticals.
• Discusses the detection and analysis of counterfeit drugs, and appropriate
tools for combating this issue.
• The editor draws on his experience as a respected chemist and prolic author
in the eld to provide this unique text on drug counterfeiting detection.
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Counterfeit Drugs Series
Series Editor
Kelly M. Elkins
Trends in Counterfeit Drugs
Edited by Kelly M. Elkins
Quantitative and Qualitative Determination Technologies on Counterfeit Drugs
Edited by Ronny Priefer
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Quantitative and
Qualitative Determination
Technologies of
Counterfeit Drugs
Edited By
Ronny Priefer
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First edition published 2024
by CRC Press
6000 Broken Sound Parkway NW, Suite 300, Boca Raton, FL 33487- 2742
and by CRC Press
4 Park Square, Milton Park, Abingdon, Oxon, OX14 4RN
© 2024 selection and editorial matter, Ronny Priefer; individual chapters, the contributors
CRC Press is an imprint of Taylor & Francis Group, LLC
Reasonable efforts have been made to publish reliable data and information, but the author and
publisher cannot assume responsibility for the validity of all materials or the consequences of their use.
The authors and publishers have attempted to trace the copyright holders of all material reproduced in
this publication and apologize to copyright holders if permission to publish in this form has not been
obtained. If any copyright material has not been acknowledged please write and let us know so we may
rectify in any future reprint.
Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced,
transmitted, or utilized in any form by any electronic, mechanical, or other means, now known or
hereafter invented, including photocopying, microlming, and recording, or in any information storage
or retrieval system, without written permission from the publishers.
For permission to photocopy or use material electronically from this work, access www.copyri ght.com
or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA 01923,
978- 750- 8400. For works that are not available on CCC please contact mpkbookspermissions@tandf.
co.uk
Trademark notice: Product or corporate names may be trademarks or registered trademarks and are used
only for identication and explanation without intent to infringe.
Library of Congress Cataloging‑in‑Publication Data
Names: Priefer, Ronny, editor.
Title: Quantitative and qualitative determination technologies of counterfeit drugs /
edited by Ronny Priefer. Other titles: Counterfeit drugs series.
Description: First edition. | Boca Raton : CRC Press, 2023. | Series: Counterfeit drugs series |
Includes bibliographical references and index. |
Identiers: LCCN 2023003286 (print) | LCCN 2023003287 (ebook) |
ISBN 9781032218922 (hardback) | ISBN 9781032218984 (paperback) |
ISBN 9781003270461 (ebook)
Subjects: MESH: Counterfeit Drugs–analysis | Drug and Narcotic Control |
Technology, Pharmaceutical | Fraud–prevention & control Classication:
LCC RS189 (print) | LCC RS189 (ebook) | NLM QV 773 |
DDC 338.476153–dc23/eng/20230516
LC record available at https://lccn.loc.gov/2023003286
LC ebook record available at https://lccn.loc.gov/2023003287
ISBN: 978- 1- 032- 21892- 2 (HB)
ISBN: 978- 1- 032- 21898- 4 (PB)
ISBN: 978- 1- 003- 27046- 1 (EB)
DOI: 10.1201/ 9781003270461
Typeset in Times
by Newgen Publishing UK
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Contents
Preface ...................................................................................................................vii
Editor ......................................................................................................................ix
Contributors ...........................................................................................................xi
Chapter 1 Screening for Bad- Quality Pharmaceuticals in Field Settings .......... 1
Marya Lieberman
Chapter 2 HPLC for Analysis of Substandard and Falsied
Medicinal Products ..........................................................................39
Eric Deconinck and Celine Vanhee
Chapter 3 Tackling a Global Crisis: A Review of the Efcacy of LC- MS ......77
Dong Hyeon Shin and Ronny Priefer
Chapter 4 Analyzing Counterfeit and Falsied Herbal Products
with GC/ MS ....................................................................................97
Maryam Akhgari and Afshar Etemadi‑ Aleagha
Chapter 5 Applications of UV- Vis Spectroscopy in Counterfeit
Medications ...................................................................................119
Jin Ba and Ronny Priefer
Chapter 6 IR Spectroscopic Analytical Tools in the Fight Against
Counterfeit Medicines ...................................................................131
Sangeeta Tanna and Rachel Armitage
Chapter 7 Using NMR Spectroscopy to Analyze Counterfeit
Medications ...................................................................................171
Alina Hoxha and Ronny Priefer
Index ...................................................................................................................193
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Preface
Although food and drug regulatory agencies exist that work diligently to ensure
that the products that enter the marketplace are of the quality and quantity that they
were approved at; whether accidently or maliciously, all too often counterfeits are
identied. This issue has seen a noticeable decrease in developed nations due to
numerous checks and balances, however cases are still periodically reported. More
troubling is the astounding level of falsied drugs that are in developing countries,
particular throughout Africa. For example, studies have shown that approximately
15% of antimalarial and antibiotic agents in and around the sub- Sahara are either
sub- therapeutic or completely devoid of any active pharmaceutical ingredients.
Additionally, as more sales of drugs are transitioning to online purchasing, less
oversight is being done, which allows for further increases in this arena.
To combat issues related to counterfeit pharmaceuticals, a variety of different
analytical techniques have been developed. These range from the inexpensive PADs
and chromatography approaches to incredibly precise, yet notoriously expensive,
NMR and MS. In addition to the cost disparity, which negates application of many
of these technologies in developing countries, some techniques cannot be utilized
for certain drug formulations. A global group of experts collaborated to bring
about a comprehensive overview of these technologies, highlighting each of their
strengths and weaknesses. The information provided in this book will greatly assist
those currently in the eld attempting to combat this growing global problem, as
well as scientists and engineers seeking to develop new technologies to reverse
this trend.
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Editor
Ronny Priefer earned his PhD from McGill University in Montreal, Canada in
Organic Chemistry. He is a full professor and Dean of Graduate Studies in the
School of Pharmacy at the Massachusetts College of Pharmacy and Health Sciences
(MCPHS) University. Prior to this, he was a professor of medicinal chemistry
at the College of Pharmacy at Western New England University and at Niagara
University in the Chemistry and Biochemistry Department. His research areas have
focused on novel surface coating in conjunction with drug delivery and stability.
He has over 100 peer- reviewed publications and multiple patents.
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