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The InternationalPharmacopoeiaFourth Edition First SupplementThe fourth edition of the International Pharmacopoeia comprisestwo main volumes published in 2006. This first Supplementincludes a collection of recommended procedures for analysisand specifications for the determination of pharmaceuticalsubstances, excipients and dosage forms that is intended to serve

as source material for reference or adaptation by any WHOMember State wishing to establish pharmaceutical requirements.

New monographs New monographs are included for fiveantiretroviral substances, for sixteen antiretroviral dosage formsincluding two fixed-dose combination preparations, for oneantimalarial dosage form and for six antituberculosis dosageforms including 2-, 3-, and 4-component fixed-dosepreparations. Such specifications support the joint UNICEF-WHO-UN Prequalification project, managed by WHO. In

developing these monographs WHO has worked closelywith manufacturers, national authorities and national qualitycontrol laboratories. New general monographs for Liquidpreparations for oral use and Oral powders are included tosupport the relevant specific dosage-form monographs. Themonograph for Liquid preparations for oral use highlights thatsuch preparations are often the dosage form of choice forpaediatric use. This general monograph also includes a statement

on Safety concerns in the section on Manufacture. This drawsattention to the importance of ensuring the quality of startingmaterials. Failure to ensure that starting materials are of therequired quality can have very serious consequences.

Revision In parallel with the development of the new monographfor Doxycycline capsules, the published monographs forDoxycycline hyclate and Doxycycline tablets have been revised andreplacement texts are included in this supplement. A requirementfor dissolution has been included for several monographs.

Infrared Reference spectra Many monographs in TheInternational Pharmacopoeia include an identification test usinginfrared spectroscopy; these tests usually allow comparison eitherwith a spectrum obtained from the ICRS or with a referencespectrum. The majority of the infrared reference spectra arenewly available and published within this supplement.

Chromatographic tests In chromatographic tests included

within the monographs of The International Pharmacopoeia,the type of chromatographic column, column packing or TLCplate to be used is stated but reference to commercial sourcesof these supports is not given. When a draft monograph iscirculated for comment, the particular column that was usedduring the development of a liquid chromatographic test isprovided for information (usually in a footnote to the text).This information is now provided on the WHO Medicineswebsite to assist analysts with respect to choice of column forthose monographs recently introduced into the Pharmacopoeia.

Pharmaceutical substances Abacavir sulfate Efavirenz Lamivudine

Stavudine Zidovudine

Dosage formsGeneral monographs

Liquid preparations for oral use Oral powders

Specific monographs Abacavir oral solution Abacavir sulfate tablets Didanosine oral powder Didanosine liquid for oral use, paediatric Didanosine tablets Doxycycline capsules Isoniazid and ethambutol hydrochloride tablets Lamivudine oral solution Lamivudine tablets

Nelfinavir Mesilate oral powder Nelfinavir Mesilate tablets Rifampicin capsules Rifampicin tablets Rifampicin and isoniazid tablets Rifampicin, isoniazid and pyrizinamide tablets Rifampicin, isoniazid, pyrizinamide

and ethambutol hydrochloride tablets Saquinavir mesilate capsules Stavudine capsules Zidovudine capsules Zidovudine oral solution

Zidovudine intravenous infusion Zidovudine and Lamivudine tablets Zidovudine Lamivudine and Abacavir tablets

Dosage formsGeneral monographs

Liquid preparations for oral use Oral powders

Specific monographs Abacavir oral solution Abacavir sulfate tablets Didanosine oral powder Didanosine liquid for oral use, paediatric Didanosine tablets Doxycycline capsules Isoniazid and ethambutol hydrochloride tablets Lamivudine oral solution Lamivudine tablets Nelfinavir Mesilate oral powder Nelfinavir Mesilate tablets Rifampicin capsules

Rifampicin tablets Rifampicin and isoniazid tablets Rifampicin, isoniazid and pyrizinamide tablets Rifampicin, isoniazid, pyrizinamide

and ethambutol hydrochloride tablets Saquinavir mesilate capsules Stavudine capsules Zidovudine capsules Zidovudine oral solution Zidovudine intravenous infusion Zidovudine and Lamivudine tablets Zidovudine Lamivudine and Abacavir tablets

First Supplement2008, 365 pages [E, F*, S*]ISBN 978 92 4 154742 0CHF/US$ 70.00In developing countries: CHF/US$ 49.00Order no. 11501639

CD-ROM International Pharmacopoeia. Fourth EditionIncluding First Supplement

This CD-ROM incorporates all new monographs,amendments and additions as published in theFirst Supplementinto the previous electronic

version of the 4th edition. Thus it will replace theformer version in a user friendly way.

New monographs included in the First Supplement

2008, CD-ROM [E]ISBN 978 92 4 154443 7CHF/US$ 200.00In developing countries: CHF/US$ 140.00Order no. 19900037

NewNew

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The InternationalPharmacopoeia

Fourth EditionThis new edition consolidates the texts of the five separate

volumes of the third edition. In preparing this consolidatededition the opportunity has been taken to review the

General notices of the Pharmacopoeia. Certainadditions and amendments have been made tothe notices in order to clarify the interpretationof the Pharmacopoeia and to facilitate applicationof the requirements by the user.

The opportunity has also been taken to improvecertain aspects of the layout and format of the

publication. In this Fourth edition all the monographtexts are brought together in one section and the

method texts in another. Each of these major sectionsare divided into appropriate sub-sections and the method

texts are numbered for ease of cross-reference.

New monographs for the following antiretroviral substances arepublished in the Fourth edition: didanosine, indinavir sulfate, nelfinavirmesilate, nevirapine, ritonavir, saquinovir, and saquinovir mesilate.

Revision of the current monograph for Oral rehydration saltshas been carried out to conform to the modified formulapublished in the 13th Model List of Essential Medicines (WHOTechnical Report Series, No. 920, 2003) and in the WHO ModelFormulary 2004. The revised formula has a reduced sodiumchloride and glucose content providing a solution with a reducedosmolarity of 245 mOsm/l. Due to the improved effectiveness ofthe reduced osmolarity ORS solution, especially for children withacute, non-cholera diarrhoea, WHO and UNICEF now recommendthat countries use and manufacture this formulation in place ofthe previously recommended ORS, i.e. the one published in thethird edition of The International Pharmacopoeia, which has

a total osmolarity of 311 mOsm/l.

Method texts that have been updated include, for example, thetext on high performance liquid chromatography [HPLC]. This hasbeen revised to clarify certain technical terms and to add adviceon adjustment of chromatographic conditions, as recommended bythe WHO Expert Committee on Specifications for PharmaceuticalPreparations in October 2004.

(see table of contents page 4.)

" deserves dueinternational recognition as abasis for standardising drug

quality control procedures"

The Pharmaceutical Journal

2006, 2 volumes 1500 pages [E]ISBN 978 92 4 156301 7CHF/US$ 400.00In developing countries: CHF/US$ 200.00Order no. 11500639

WHP.DIV.1639Order form

Please send me___ copies of The InternationalPharmacopoeia, 4th edition at the price of CHF/US$ 400.00;In developing countries: CHF/US$ 200.00 (order no. 11500639)Please send me___ copies of The InternationalPharmacopoeia, 4th edition First Supplement at the priceof CHF/US$70.00; In developing countries: CHF/US$ 49.00

(order no. 11501639)Please send me ___ copies of The InternationalPharmacopoeia, 4th edition CD-ROM at the price ofCHF/US$ 200.00; In developing countries: CHF/US$ 140.00(order no. 19900037)

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Contents Preface H is tory Acknowledgements General Notices Abbreviations and

symbols Units of measurement Names, symbols and

relative atomicmasses of certain

elements International chemicalreference substances

MonographsThe fourth edition includes all themonographs in the third editiontogether with new monographslisted overleaf. The monographs arepresented in the following sections:

Pharmaceutical Substances(all monographs for activeingredients and excipients in onealphabetical sequence)

Dosage Forms General monographs:

Capsules, Ophthalmicpreparations, Parenteralpreparations, Suppositories,Tablets, Topical Semi-soliddosage forms

Individual monographs:(all individual monographs inalphabetical order)

Radiopharmaceuticals

Methods of analysis1. Physical and

PhysicochemicalMethods

2. Chemical methods3. Biological methods4. Methods for materials

of plant origin5. Pharmaceutical

technical procedures

Reagents, TestSolutions andVolumetric Solutions

SupplementaryInformation

Inde x

SPECIAL OFFER

International Chemical ReferenceSubstances (ICRS)

To coincide with the publication of the updated fourth edition of The International

Pharmacopoeia, the WHO Collaborating Centre for Chemical Reference Substances is offeringa special 50 % discount to National Authorities on orders for the International ChemicalReference Substances (ICRS) needed to support the International Pharmacopoeia monographs.

This offer is valid until 31 December 2008 for one order per national control laboratory witha maximum order of 10 vials per laboratory.

For ordering information, please visit http://www.apl.apoteket.se/who.

The International Pharmacopoeia, 4th edition