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I am involved with the introduction of a new Masters course in Pharmaceutical
Analysis in University College Cork, Ireland. I am looking for some useful
sources of information on such areas as separation techniques used in the
industry, GMP, FDA, validation etc. any good teaching material really. If
anyone can lead me in the right direction I would be grateful
Regards
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[Two replies - db]
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Date: Thu, 13 Aug 1998 16:23:58 -0400 (EDT)
From: George Lunn 301-827-2393 FAX 301-827-2510
Subject: Re: FWD: Pharmaceutical Analysis
To: Norman Schmuff, david.at.pharm.cpb.ouhsc.edu
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Posting-date: Thu, 13 Aug 1998 16:24:00 -0400 (EDT)
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>I am involved with the introduction of a new Masters course in
Pharmaceutical Analysis in University College Cork, Ireland. I am
looking for some useful sources of information on such areas as
separation techniques used in the industry, GMP, FDA, validation etc.
any good teaching material really. If anyone can lead me in the right
direction I would be grateful Regards
You might be interested in our recently published book as a practical
guide to pharmaceutical HPLC analyses.
George Lunn
"HPLC Methods for Pharmaceutical Analysis" G. Lunn & N.R. Schmuff
John Wiley & Sons, NY, 1997
Book Only $225 ISBN 1-18176-5 (0471181765) 1605 pages
Book & CD $495 ISBN 1-13078-8
CD Only $325 ISBN 1-18198-6
This book is available both as a conventional bound volume and as a CD.
The CD version will run on a Macintosh and under Windows (3.1 or 95).
The CD version offers the advantages of searching for relevant papers
using Boolean logic but the information contained in the two versions is
identical. Network licenses are available for the CD version.
This book is a collection of procedures for the analysis of a number of
pharmaceuticals using high-performance liquid chromatography (HPLC).
For each compound various techniques are described in sufficient detail
that the analyst can replicate the procedure without reference to the
original publication. Since detailed procedures for the same drug are
listed together, it is very easy for the researcher to combine features
of different methods, e.g., the extraction procedure from one paper and
the chromatographic procedure from another paper, to provide methods
tailored to the researcher's requirements. In addition to the detailed
procedures, bibliographies are provided listing other references. These
references are annotated so that the reader can rapidly determine those
procedures likely to be of the most utility. In the current volume, we
have listed procedures for the analysis of the most commonly used drugs
in the United States. In future volumes we hope to cover the remaining
drugs used for medical and veterinary purposes.
The impetus for writing this book was the realization that there was no
single volume listing analytical procedures and that there was, in
particular, no ready source of information on the analysis of drugs in
biological fluids other than the original literature. Although a number
of methods are in common use for the analysis of pharmaceuticals, HPLC
may be regarded as the "gold standard" and so we have decided to
concentrate on this procedure. For example, HPLC assays of antibiotics
have advantages such as specificity, better accuracy and precision, and
wider availability of equipment, over other methods. Thus, HPLC
procedures are gradually coming to replace other techniques.
Although the universal penetration of computers has led to readily
available laboratory-based searches of the literature, this resource is
not exploited as much as it might be. An ACS symposium speaker has
stated that many pharmaceutical firms admit, when questioned about
deficiencies in this area, to never having performed a literature search
for HPLC methods . One reason for this reluctance is, of course, that a
computer search merely produces a listing of possibly relevant
references. Tedious and time- consuming searches in the library are
necessary to find the most relevant reference that can be turned into a
practical analytical procedure in the searcher's own laboratory. The
reference finally chosen will depend on the individual circumstances
such as the matrix in which the drug is present and availability of
equipment. This book circumvents this lengthy process by providing a
number of abstracted and evaluated procedures for the analysis of each
drug. The analyst can rapidly identify a relevant procedure and put it
into practice without having to consult the original literature. For
many compounds the number of analytical procedures is so large that it
is not possible to fully abstract all of them. For this reason we have
added annotated bibliographies so that the researcher can rapidly
identify a relevant paper without having to locate and evaluate a large
number of irrelevant procedures.
In addition to the analytical matrix, other factors may be important
when choosing an analytical procedure. Accordingly, we have noted other
features of the analytical procedures such as sensitivity, mode of
detection, other compounds that interfere with the analysis, and other
drugs that may be determined at the same time. In general, the
literature is covered from January 1980 to March 1996, but a few earlier
references are included.
Each monograph is headed by the name and structure of the target
compound as well as the CAS Registry Number, molecular formula, and
molecular weight. At the end of the book other names, such as Trade
Names, that are used for this compound are given with references to the
relevant monograph. Also at the end of the book cross references are
given to the relevant abstracts in The Merck Index and the relevant
sections in the series Organic Chemistry of Drug Synthesis by Lednicer
and Mitscher.
Each monograph comprises two sections: Procedures and Annotated
Bibliography. The first section presents detailed procedures which
should enable anyone to reproduce the analyses. The second section
lists other relevant papers, but does not give any experimental details.
However, some key words are given to indicate key features of the
procedure that are not referred to in the title. The intent of this
section is to allow readers to determine rapidly if a paper is relevant
and worth looking up in the library.
The detailed procedures given in the first section of each monograph
normally contain the following sections. Of course, not all papers give
full details, so some sections may be missing.
Reference
Matrix
Sample Preparation
Guard Column
Column
Mobile Phase
Flow Rate
Injection Volume
Retention Time
Detector
Internal Standard
Limit of Detection
Limit of Quantitation
Drugs that are Extracted under these Conditions
Drugs that are Chromatographed Simultaneously under these
Conditions
Drugs that are also Chromatographed under these Conditions
Drugs that are Non-interfering
Drugs that are Interfering
Key Words
--
The following is a comprehensive list of drugs covered:
Acetaminophen Imipenem
Acyclovir Indapamide
Adiphenine Insulin
Albuterol Interferon
Alprazolam Ipratropium Bromide
Alteplase Ketoconazole
Amitriptyline Ketoprofen
Amlodipine Ketorolac
Amoxicillin Leuprolide
Ampicillin Levothyroxine
Aspirin Lisinopril
Astemizole Loracarbef
Atenolol Loratadine
Atropine Lorazepam
Azathioprine Lovastatin
Azithromycin Medroxyprogesterone Acetate
Beclomethasone Dipropionate Methylphenidate
Benazepril Methylprednisolone
Betamethasone Metoprolol
Bromocriptine Midazolam
Buspirone Mometasone Furoate
Butalbital Mupirocin
Captopril Nabumetone
Carbamazepine Naproxen
Carboplatin Neomycin
Carisoprodol Nifedipine
Cefaclor Nitrofurantoin
Cefadroxil Nitroglycerin
Cefixime Nizatidine
Cefotaxime Norethindrone
Cefprozil Norgestrel
Ceftazidime Nortriptyline
Ceftriaxone Ofloxacin
Cefuroxime Omeprazole
Cephalexin Ondansetron
Cilastatin Oxaprozin
Cimetidine Oxycodone
Ciprofloxacin Paclitaxel
Cisapride Penicillin V
Clarithromycin Pentoxifylline
Clavulanic acid Phenylpropanolamine
Clindamycin Phenytoin
Clonazepam Piroxicam
Clotrimazole Polymyxin
Clozapine Pravastatin
Codeine Prednisone
Cromolyn Promethazine
Cyclobenzaprine Propofol
Cyclosporine Propoxyphene
Desogestrel Quinapril
Diazepam Ramipril
Diclofenac Ranitidine
Dicyclomine Retinoic acid
Digoxin Salmeterol
Diltiazem Scopolamine
Doxazosin Sertraline
Doxycycline Simvastatin
Enalapril Somatropin
Epoetin Sucralfate
Erythromycin Sulbactam
Estradiol Sulfamethoxazole
Estrogens, Conjugated Sumatriptan
Ethinyl Estradiol Temazepam
Ethynodiol Diacetate Terazosin
Etodolac Terbinafine
Etoposide Terconazole
Famotidine Terfenadine
Finasteride Tetracycline
Fluconazole Theophylline
Fluoxetine Timolol
Flutamide Tramadol
Fluvastatin Triamcinolone
Furosemide Triamterene
Gemfibrozil Trimethoprim
Glipizide Valproic acid
Glyburide Vancomycin
Goserelin Venlafaxine
Guaifenesin Verapamil
Hydrochlorothiazide Warfarin
Hydrocodone Zidovudine
Hydrocortisone Zolpidem
Ibuprofen
To order in the US, Central and South America, contact
John Wiley & Sons, Inc.
T: (732) 469-4400
F: (732) 302-2300
e-mail: custserv.at.wiley.com
To Order in Canada,
John Wiley & Sons, Ltd.
T: (416)-675-3580
F: (416) 675-6599
To Order in UK, Europe, Japan, Middle East and Africa
John Wiley & Sons, Ltd.
T: 011-44 (0243) 779777
F: 011-44 (0243) 820250
e-mail: cs-books.at.wiley.co.uk
In the Far East (other than Japan)
John Wiley & Sons (Asia) Pte Ltd.
T (65)460-4280
F: (65) 463-4605/463-4606
e-mail: wiley.at.singnet.com.sg
In Australia, New Zealand, Papua New Guinea, Pacific Islands, and
Western
Samoa
Jacaranda Wiley, Ltd.
T: 61 (7) 38599755
F: 61 (7) 38599715
You can also order online from the Amazon.com. Search by author or
title at:
http://www.amazon.com/exec/obidos/ats-query-page
---
Alternate-recipient: prohibited
Date: Thu, 13 Aug 1998 16:32:08 -0400 (EDT)
From: Norman Schmuff 301-827-2425 FAX 301-827-2510
Subject: RE: Pharmaceutical Analysis
To: david
MIME-version: 1.0
Posting-date: Thu, 13 Aug 1998 16:39:00 -0400 (EDT)
Importance: normal
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You might take a look at some of the FDA and ICH documents which reside on
their respective web sites (www.fda.gov/cder/guidance/index.htm and
www.ifpma.org/ich1.htm) particularly those dealing with analytical methods
validation.
Also the Pharmacopias (Pharmacopoeias) would have methods. Check out the USP,
EP, and BP.
| Norman R. Schmuff, Ph.D.
| Food and Drug Admin, HFD-590 (CORP)
| 5600 Fishers Ln
| Rockville, MD 20857
| SchmuffN.at.CDER.FDA.gov
PharmPC Discussion List Archive Index page
David Bourne (david@boomer.org)