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.Analytical ProfilesofDrug SubstancesVolume 16.EDITORIAL BOARDAbdullah A. Al-Badr Steven A.
Benezra Eugene Inman Gerald S. Brenner Joseph Mollica Glenn A. Nicholas DeAngelis John ZaremboLee T. GradyMilton D. Yudis.Analytical Profiles ofDrug Substances Volume 16Edited byKlaus Florey The Squibb Institute for Medical ResearchNew Brunswick, New JerseyContributing EditorsAbdullah A.
Al-Badr Gerald S. Brenner1987ACADEMIC PRESS, INC. Harcourt Brace Jovanovich, PublishersOrlando San Diego New York Ailstin Boston London Sydney Tokyo Toronto.Academic Press Rapid Manuscript ReproductionCOPYRIGHT 0 1987 BY ACADEMIC PRESS. 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 32887United Kingdom Edition published by ACADEMIC PRESS INC. (LONDON) LTD. 24-28 Oval Road, London NW I 7DXLibrary of Congress Cataloging in Publication Data (Revised for volume 16)Analytical profiles o f drug substances.Compiled under the auspices o f the Pharmaceutical Analysis and Control Section, Academy of Pharmaceutical Sciences.Includes bibliographical references and indexes. Drugs-Analysis-Collected works.
Chemistry,Pharmaceutical-Collected works. Florey, Klaus, 11. Brewer, Glenn A. Academy of Pharmaceutical Sciences. Pharmaceutical Analysis Control Section. QV740 AA1 ASSISBN 0-12-260816-X (v.
Paper) RS 189.A58 6 lSI.1 70-187259PRINTED IN THE UNITED STATES OF AMERICA8 7 8 8 8 9 9 0 9 8 7 6 5 4 3 2 1.CONTENTSAffiliations of Editors and Contributors PrefaceBromazepam Mahmoud M. Hassan and Mohammad A. AbounassifBusulphan Mohammad Tariq and Abdullah A. Al-BadrC hlo ram bucil Mohammad Tariq and Abdutlah A. Al-BadrChlorzoxazone James T. Stewart and Casimir A.
JanickiC yclosporine Mahmoud M. Hassan and Mohammed A. Al-YahyaEnalapril Maleate Dominic P. Fp and Gerald S.
Ole Borud Shakin The Ground Rar Extractor Download
BrennerHomatropine Hydrobromide Farid J. Muhtadi, Mahmoud M. Hassan, and Abdul Fattah A. AfifyMebendazole A.
Al-Badr and M. Tariquii ir520724529 1V.vi CONTENTSMetoclopramide Hydrochloride Davide Pitre and Riccardo StrudiMitomycin C Jos H. Beijnen, Auke Bult, and Willy J. M.Neostigmine A.
Al-Badr and M. TuriyJnderbergPirenzepine Dihydrochloride Humeida A.
El-Obeid, Salim A. Babhair, and Abdullah A. Al-BadrStreptomycin faber S. Mossa, Abdut Hameed U.
Kader Taragan, and Mahmoud M. HassanThiabendazole Vijuy K.
KapoorTimolol Maleate David J. Mazzo and Alice E, LoperTrazodone Hydrochloride Dennis K. Gorecki and Roger K. VerbeeckYohimbine A.
Mekkawi and A. Al-BadrCumulative Index44550761 164 1.AFFILIATIONS OF EDITORS AND CONTRIBUTORSMohammad 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 TriangleGerald S.
Brenner, Merck Sharp & Dohme Research Laboratories, WestGlenn A. Brewer, Jr., The Squibb Institute for Medical Research, NewAuke 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. Gorecki, College of Pharmacy, University of Saskatchewan,Lee T. Grady, The United States Pharmacopeia, Rockville, Maryland Mahmoud M. Hassan, King Saud University, Riyadh, Saudi Arabia Eugene L. Inman, Lilly Research Laboratories, Indianapolis, IndianaRiyadh, Saudi ArabiaRiyadh, Saudi ArabiaRiyadh, Saudi ArabiaSaudi ArabiaPark, North CarolinaPoint, PennsylvaniaBrunswick, New JerseyThe Netherlandswick, New JerseySaskatoon, Saskatchewan, Canadavii.AFFILIATIONS.Vll lDominic P.
I p, Merck Sharp & Dohme Research Laboratories, WestCasimir A. Janicki, McNeil Pharmaceutical, Spring House, Pennsyl-Vijay K. Kapoor, Department of Pharmaceutical Sciences, Panjab Uni-Alice E.
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Loper, Merck Sharp & Dohme Research Laboratories, WestDavid J. Mazzo, Travenol Laboratories, Morton Grove, Illinois A. 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. 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.
Rorer, Inc., Fort Washington, PennsylvaniaPoint, Pennsylvaniavaniaversity, Chandigarh, IndiaPoint, PennsylvaniaSaudi ArabiaSaudi ArabiaGeorgiaversity, Riyadh, Saudi ArabiaSaudi ArabiaUtrecht, The NetherlandsSaskatoon, Saskatchewan, Canada.PREFACEAlthough 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 Floreyix.This Page Intentionally Left Blank.BROMAZEPAMMahmoud M.A. H a h a n, PhO6eAhOh 06 PhahmaceuLLcd C h m h L t y, Depah;tment od PhahmaceuLLcd C h m h L t y, CoMege 06 Phanmacy, King Saud U n L v m L t q, Riyadh, Saudi Axabia.Mohammad A.
Abuumnid, AnbhXant Phodeddon 04 PhamaceuLi- c d C h m h i x y, Heud 04 Xhe DepdmenX 06 P h a m a c e d i c d C h m h L t y, College 06 Phahmacy, King Saud Un ivmi, t y, Riyadh, Saudi Arrabia.1. His tory and Therapeut ic Category2. Descr ip t ion2.1 Nomenclature2.
2 Formulae2.3 Molecular WeightANALYTICAL PROFILES OF DRUG SUBSTANCES VOLUME 16Copyright 0 1987 by Academic Press, Inc. All rights of reproduction in any form reserved. 1.2 MAHMOUD M. HASSAN AND MOHAMMAD A.
Physical P rope r t i e s3.1 Appearance, Color, Odor and Taste3.2 Melting Range3.3 Dissoc ia t ion Constants3.4 Crys ta l S t ruc tu re4, Spec t r a l P rope r t i e s4.1 U l t r a v i o l e t Spectrum4.2 In f r a red Spectrum4.3 Nuclear Magnetic Resonance Spec t ra4.4 Mass Spectrum5. Pharmacokinetic S tudies8. Methods of Analysis8.1 Elemental Analysis8.2 I d e n t i f i c a t i o n Tests8.3 T i t r i m e t r i c8.4 Spectrophotometric8.5 Polarographic8.6 Atomic Absorption8.7 Radioimunoassays8.8 Chromatographic9. References.B R 0 MAZE P AM 3Analytical P r o f i l e of Bromazepam1.