Analytical Profiles of Drug Substances

783 Pages·2010·20.26 MB·English

Analytical Profiles
of
Drug Substances
Volume 16
EDITORIAL BOARD
Abdullah A. Al-Badr Lee T. Grady
Steven A. Benezra Eugene Inman
Gerald S. Brenner Joseph Mollica
Glenn A. Brewer, Jr. Milton D. Yudis
Nicholas DeAngelis John Zarembo
Analytical Profiles
of
Drug Substances
Volume 16
Edited by
Klaus Florey
The Squibb Institute for Medical Research
New Brunswick, New Jersey
Contributing Editors
Abdullah A. Al-Badr Gerald S. Brenner
1987
ACADEMIC PRESS, INC.
Harcourt Brace Jovanovich, Publishers
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COPYRIGHT 0 1987 BY ACADEMIPCR ESS. INC.
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ACADEMIC PRESS, INC.
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United Kingdom Edition published by
ACADEMIC PRESS INC. (LONDON) LTD.
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Library of Congress Cataloging in Publication Data
(Revised for volume 16)
Analytical profiles of drug substances.
Compiled under the auspices of the Pharmaceutical
Analysis and Control Section, Academy of Pharmaceutical
Sciences.
Includes bibliographical references and indexes.
1. Drugs-Analysis-Collected works. 2. Chemistry,
Pharmaceutical-Collected works. I. Florey, Klaus,
11. Brewer, Glenn A. 111. Academy of Pharmaceutical
Sciences. Pharmaceutical Analysis Control Section.
[DNLM: 1. Drugs-Analysis-Yearbooks. QV740 AA1 ASS]
RS 189.A58 6 lSI.1 70-187259
ISBN 0-12-260816-X (v. 16 : alk. paper)
PRINTED IN THE UNITED STATES OF AMERICA
87888990 9 8 7 6 5 4 3 2 1
CONTENTS
Affiliations of Editors and Contributors uii
Preface ir
Bromazepam 1
Mahmoud M. A. Hassan and
Mohammad A. Abounassif
Busulphan 53
Mohammad Tariq and Abdullah A. Al-Badr
Ch lo ram bucil 85
Mohammad Tariq and Abdutlah A. Al-Badr
Chlorzoxazone 119
James T. Stewart and Casimir A. Janicki
C yclosporine 145
Mahmoud M. A. Hassan and Mohammed A. Al-Yahya
Enalapril Maleate 207
Dominic P. fp and Gerald S. Brenner
Homatropine Hydrobromide 245
Farid J. Muhtadi, Mahmoud M. A. Hassan, and
Abdul Fattah A. Afify
Mebendazole 29 1
A. A. Al-Badr and M. Tariq
V
vi CONTENTS
Metoclopramide Hydrochloride 327
Davide Pitre and Riccardo Strudi
Mitomycin C 36 1
Jos H. Beijnen, Auke Bult, and Willy J. M. Jnderberg
Neostigmine 403
A. A. Al-Badr and M. Turiy
Pirenzepine Dihydrochloride 445
Humeida A. El-Obeid, Salim A. Babhair, and
Abdullah A. Al-Badr
Streptomycin 507
faber S. Mossa, Abdut Hameed U. Kader Taragan,
and Mahmoud M. A. Hassan
Thiabendazole 61 1
Vijuy K. Kapoor
Timolol Maleate 64 1
David J. Mazzo and Alice E, Loper
Trazodone Hydrochloride 693
Dennis K. G. Gorecki and Roger K. Verbeeck
Yohimbine 73 1
A. G. Mekkawi and A. A. Al-Badr
Cumulative Index 769
AFFILIATIONS OF
EDITORS AND CONTRIBUTORS
Mohammad A.A bounassif, College of Pharmacy, King Saud University,
Riyadh, Saudi Arabia
Abdul Fattah A. Afify, College of Pharmacy, King Saud University,
Riyadh, Saudi Arabia
Abdullah A. Al-Budr, King Saud University, Riyadh, Saudi Arabia
Mohammed A. Al-Yahya, College of Pharmacy, King Saud University,
Riyadh, Saudi Arabia
Salim A. Babhair, College of Pharmacy, King Saud University, Riyadh,
Saudi Arabia
Jos H. Beijnen, Slotervaart Hospital, Amsterdam, The Netherlands
Steven A. Benezra, Wellcome Research Laboratories, Research Triangle
Park, North Carolina
Gerald S. Brenner, Merck Sharp & Dohme Research Laboratories, West
Point, Pennsylvania
Glenn A. Brewer, Jr.,T he Squibb Institute for Medical Research, New
Brunswick, New Jersey
Auke Bult, Faculty of Pharmacy, State University of Utrecht, Utrecht,
The Netherlands
Nicholas J. DeAngelis, Wyeth Laboratories, Philadelphia, Pennsylvania
Humeida A. El-Obeid, King Saud University, Riyadh, Saudi Arabia
Klaus Florey, The Squibb Institute for Medical Research, New Bruns-
wick, New Jersey
Dennis K. G.G orecki, College of Pharmacy, University of Saskatchewan,
Saskatoon, Saskatchewan, Canada
Lee T. Grady, The United States Pharmacopeia, Rockville, Maryland
Mahmoud M. A. Hassan, King Saud University, Riyadh, Saudi Arabia
Eugene L. Inman, Lilly Research Laboratories, Indianapolis, Indiana
vii
...
Vlll AFFILIATIONS
Dominic P. Ip, Merck Sharp & Dohme Research Laboratories, West
Point, Pennsylvania
Casimir A. Janicki, McNeil Pharmaceutical, Spring House, Pennsyl-
vania
Vijay K. Kapoor, Department of Pharmaceutical Sciences, Panjab Uni-
versity, Chandigarh, India
Alice E. Loper, Merck Sharp & Dohme Research Laboratories, West
Point, Pennsylvania
David J. Mazzo, Travenol Laboratories, Morton Grove, Illinois
A. G. Mekkawi, College of Pharmacy, King Saud University, Riyadh,
Saudi Arabia
Joseph A. Mollica, Pharmaceuticals, Du Pont, Wilmington, Delaware
Jaber S. Mossa, College of Pharmacy, King Saud University, Riyadh,
Saudi Arabia
Farid J. Muhtadi, King Saud University, Riyadh, Saudi Arabia
Davide Pitrc?, Faculty of Pharmacy, University of Milan, Milan, Italy
James T. Stewart, College of Pharmacy, University of Georgia, Athens,
Georgia
Riccardo Stradi, Faculty of Pharmacy, University of Milan, Milan, Italy
Abdul Hameed U. Kader Taragan, College of Pharmacy, King Saud Uni-
versity, Riyadh, Saudi Arabia
Mohammad Tariq, College of Pharmacy, King Saud University, Riyadh,
Saudi Arabia
WillyJ . M. Underberg, Faculty of Pharmacy, State University of Utrecht,
Utrecht, The Netherlands
Roger K. Verbeeck, College of Pharmacy, University of Saskatchewan,
Saskatoon, Saskatchewan, Canada
Milton D. Yudis, Schering-Plough, Kenilworth, New Jersey
John E. Zarembo, W. H. Rorer, Inc., Fort Washington, Pennsylvania
PREFACE
Although the official compendia define a drug substance as to identity,
purity, strength, and quality, they normally do not provide other physical
or chemical data, nor do they list methods of synthesis or pathways of
physical or biological degradation and metabolism. Such information is
scattered through the scientific literature and the files of pharmaceutical
laboratories.
I perceived a need to supplement the official compendial standards of
drug substances with a comprehensive review of such infoimation, and
sixteen years ago the first volume of Anulyticul Profiles of Drug Sub-
stances was published under the auspices of the Pharmaceutical Analy-
sis and Control Section of the APhA Academy of Phaimaceutical Sci-
ences. That we were able to publish one volume per year is a tribute to
the diligence of the editors to solicit articles and even more so to the
enthusiastic response of our authors, an international group associated
with pharmaceutical firms, academic institutions, and compendial au-
thorities. I would like to express my sincere gratitude to them for making
this venture possible.
Over the years, we have had queries concerning our publication pol-
icy. Our goal is to cover all divg substances of medical value and, there-
fore, we have welcomed any articles of interest to an individual contrib-
utor. We also have endeavored to solicit profiles of the most useful and
used medicines, but many in this category still need to be profiled.
Klaus Florey
ix