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USP32

GENERAL NOTICES AND REQUIREMENTS

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The General Notices and Requirements section (the General Notices) presents the basic assumptions, definitions, and default conditions for the interpretation and application of the United States Pharmacopeia (USP) and the National Formulary (NF).

Requirements stated in these General Notices apply to all articles recognized in the USP and NF (the “compendia”) and to all general chapters unless specifically stated otherwise. Where the requirements of an individual monograph differ from the General Notices or a general chapter, the monograph requirements apply and supersede the requirements of the General Notices or the general chapter, whether or not the monograph explicitly states the difference.

TITLE AND REVISION

The full title of this publication (consisting of three volumes and including its Supplements), is The Pharmacopeia of the United States of America, Thirty-Second Revision and the National Formulary, Twenty-Seventh Edition. These titles may be abbreviated to United States Pharmacopeia, Thirty-Second Revision (or to USP 32), to NF 27, and to USP 32–NF 27. The United States Pharmacopeia, Thirty-Second Revision, and the National Formulary, Twenty-Seventh Edition, supersede all earlier revisions. Where the terms “USP,” “NF,” or “USP–NF” are used without further qualification during the period in which these compendia are official, they refer only to USP 32, NF 27, and any Supplement(s) thereto. The same titles, with no further distinction, apply equally to print or electronic presentation of these contents. Although USP and NF are published under one cover and share these General Notices, they are separate compendia.

This revision is official beginning May 1, 2009, unless otherwise indicated in specific text.

Supplements to USP and NF are published periodically.

Interim Revision Announcements are revisions to USP and NF that are published in Pharmacopeial Forum. Interim Revision Announcements contain official revisions and their effective dates, announcements of the availability of new USP Reference Standards, and announcements of tests or procedures that are held in abeyance pending availability of required USP Reference Standards.

Revision Bulletins are revisions to official text or postponements that require expedited publication. They are published on the USP website and generally are official immediately unless otherwise specified in the Revision Bulletin.

Errata are corrections to items erroneously published that have not received the approval of the Council of Experts and that do not reflect the official requirements. Errata are effective upon publication.

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British Pharmacopoeia 2009

Published on the recommendation of the Commission on Human Medicines pursuant to the
Medicines Act 1968 and notified in draft to the European Commission in accordance with
Directive 98/34/EEC
The monographs of the Sixth Edition of the European Pharmacopoeia (2007), as amended by
Supplements 6.1 and 6.2 published by the Council of Europe, are reproduced either in this
edition of the British Pharmacopoeia or in the associated edition of the British Pharmacopoeia
(Veterinary).
See General Notices
Effective date: 1 January 2009
see Notices
London: The Stationery Office
In respect of Great Britain:
THE DEPARTMENT OF HEALTH
In respect of Northern Ireland:
THE DEPARTMENT OF HEALTH, SOCIAL SERVICES AND PUBLIC SAFETY
© Crown Copyright 2008
Published by The Stationery Office on behalf of the Medicines and Healthcare products
Regulatory Agency (MHRA) except that:
European Pharmacopoeia monographs are reproduced with the permission of the Council of
Europe and are not Crown Copyright. These are identified in the publication by a chaplet of
stars.
This publication is a 'value added' product. If you wish to re-use the Crown Copyright material
from this publication, applications must be made in writing, clearly stating the material
requested for re-use, and the purpose for which it is required. Applications should be sent to:
Dr M G Lee, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ or by e-mailing:
ged.lee@mhra.gsi.gov.uk.
First Published 2008
ISBN 978 0 11 322799 0
British Pharmacopoeia Commission Office:
Market Towers
1 Nine Elms Lane
London SW8 5NQ
Telephone: +44 (0)20 7084 2561

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