Analytical Profiles of Drug Substances [Vol 16] - K. Florey (AP, 1987) WW PDF
Preview Analytical Profiles of Drug Substances [Vol 16] - K. Florey (AP, 1987) WW
Analytical Profiles of Drug Substances Volume 16 EDITORIAL BOARD Abdullah A. Al-Badr Steven A. Benezra Eugene Inman Gerald S. Brenner Joseph Mollica Glenn A. Brewer, Jr. Nicholas DeAngelis John Zarembo Lee T. Grady Milton D. Yudis 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 Orlando San Diego New York Ailstin Boston London Sydney Tokyo Toronto Academic Press Rapid Manuscript Reproduction COPYRIGHT 0 1987 BY ACADEMIC PRESS. INC. ALL RIGHTS RESERVED. NO PART OF THIS PUBLICATION MAY BE REPRODUCED OR TRANSMITTED IN ANY FORM OR BY ANY MEANS, ELECTRONIC OR MECHANICAL, INCLUDING PHOTOCOPY, RECORDING, OR ANY INFORMATION STORAGE AND RETRIEVAL SYSTEM, WITHOUT PERMISSION IN WRITING FROM THE PUBLISHER. ACADEMIC PRESS, INC. Orlando, Florida 32887 United Kingdom Edition published by ACADEMIC PRESS INC. (LONDON) LTD. 24-28 Oval Road, London NW I 7DX 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] ISBN 0-12-260816-X (v. 16 : alk. paper) RS 189.A58 6 lSI.1 70-187259 PRINTED IN THE UNITED STATES OF AMERICA 8 7 8 8 8 9 9 0 9 8 7 6 5 4 3 2 1 CONTENTS Affiliations of Editors and Contributors Preface Bromazepam Mahmoud M . A. Hassan and Mohammad A. Abounassif Busulphan Mohammad Tariq and Abdullah A. Al-Badr C hlo ram bucil Mohammad Tariq and Abdutlah A. Al-Badr Chlorzoxazone James T. Stewart and Casimir A. Janicki C yclosporine Mahmoud M. A. Hassan and Mohammed A. Al-Yahya Enalapril Maleate Dominic P. fp and Gerald S. Brenner Homatropine Hydrobromide Farid J . Muhtadi, Mahmoud M . A. Hassan, and Abdul Fattah A. Afify Mebendazole A. A. Al-Badr and M . Tariq uii ir 1 53 85 119 145 207 245 29 1 V vi CONTENTS Metoclopramide Hydrochloride Davide Pitre and Riccardo Strudi Mitomycin C Jos H . Beijnen, Auke Bult, and Willy J . M . Neostigmine A. A. Al-Badr and M . Turiy Jnderberg Pirenzepine Dihydrochloride Humeida A. El-Obeid, Salim A. Babhair, and Abdullah A. Al-Badr Streptomycin faber S. Mossa, Abdut Hameed U. Kader Taragan, and Mahmoud M . A. Hassan Thiabendazole Vijuy K . Kapoor Timolol Maleate David J. Mazzo and Alice E , Loper Trazodone Hydrochloride Dennis K . G. Gorecki and Roger K . Verbeeck Yohimbine A. G. Mekkawi and A. A. Al-Badr Cumulative Index 327 36 1 403 445 507 61 1 64 1 693 73 1 769 AFFILIATIONS OF EDITORS AND CONTRIBUTORS Mohammad A. Abounassif, College of Pharmacy, King Saud University, Abdul Fattah A. Afify, College of Pharmacy, King Saud University, Abdullah A. Al-Budr, King Saud University, Riyadh, Saudi Arabia Mohammed A. Al-Yahya, College of Pharmacy, King Saud University, Salim A. Babhair, College of Pharmacy, King Saud University, Riyadh, Jos H. Beijnen, Slotervaart Hospital, Amsterdam, The Netherlands Steven A. Benezra, Wellcome Research Laboratories, Research Triangle Gerald S. Brenner, Merck Sharp & Dohme Research Laboratories, West Glenn A. Brewer, Jr., The Squibb Institute for Medical Research, New Auke Bult, Faculty of Pharmacy, State University of Utrecht, Utrecht, 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- Dennis K . G . Gorecki, College of Pharmacy, University of Saskatchewan, 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 Riyadh, Saudi Arabia Riyadh, Saudi Arabia Riyadh, Saudi Arabia Saudi Arabia Park, North Carolina Point, Pennsylvania Brunswick, New Jersey The Netherlands wick, New Jersey Saskatoon, Saskatchewan, Canada vii AFFILIATIONS ... Vlll Dominic P. Ip, Merck Sharp & Dohme Research Laboratories, West Casimir A. Janicki, McNeil Pharmaceutical, Spring House, Pennsyl- Vijay K . Kapoor, Department of Pharmaceutical Sciences, Panjab Uni- Alice E . Loper, Merck Sharp & Dohme Research Laboratories, West David J . Mazzo, Travenol Laboratories, Morton Grove, Illinois A. G. Mekkawi, College of Pharmacy, King Saud University, Riyadh, Joseph A. Mollica, Pharmaceuticals, Du Pont, Wilmington, Delaware Jaber S. Mossa, College of Pharmacy, King Saud University, Riyadh, 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, Riccardo Stradi, Faculty of Pharmacy, University of Milan, Milan, Italy Abdul Hameed U. Kader Taragan, College of Pharmacy, King Saud Uni- Mohammad Tariq, College of Pharmacy, King Saud University, Riyadh, Willy J . M . Underberg, Faculty of Pharmacy, State University of Utrecht, Roger K . Verbeeck, College of Pharmacy, University of Saskatchewan, Milton D. Yudis, Schering-Plough, Kenilworth, New Jersey John E . Zarembo, W. H. Rorer, Inc., Fort Washington, Pennsylvania Point, Pennsylvania vania versity, Chandigarh, India Point, Pennsylvania Saudi Arabia Saudi Arabia Georgia versity, Riyadh, Saudi Arabia Saudi Arabia Utrecht, The Netherlands Saskatoon, Saskatchewan, Canada 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
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