''The International Pharmacopoeia'' (''Pharmacopoeia Internationalis'', ''Ph. Int.'') is a
pharmacopoeia
A pharmacopoeia, pharmacopeia, or pharmacopoea (from the obsolete typography ''pharmacopœia'', meaning "drug-making"), in its modern technical sense, is a book containing directions for the identification of compound medicines, and published by ...
issued by the
World Health Organization
The World Health Organization (WHO) is a specialized agency of the United Nations responsible for international public health. The WHO Constitution states its main objective as "the attainment by all peoples of the highest possible level o ...
as a recommendation, with the aim to provide international quality specifications for pharmaceutical substances (active ingredients and
excipient
An excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts (thus often referred ...
s) and
dosage form
Dosage forms (also called unit doses) are pharmaceutical drug products in the form in which they are marketed for use, with a specific mixture of active ingredients and inactive components (excipients), in a particular configuration (such as a ca ...
s,
together with supporting general methods of analysis, for global use. Its texts can be used or adapted by any WHO member state wishing to establish legal pharmaceutical requirements.
The ''Ph.Int.'' is based primarily on medicines included in the current WHO Model List of Essential Medicines (EML) and medicines included in the current invitations to manufacturers to submit an expression of interest (EOI) to the WHO Prequalification Team – Medicines (PQT) and those of interest to other UN Organizations. In recent years, priority has been given to medicines of importance in low and middle income countries, which may not appear in any other pharmacopoeias, including child-friendly dosage forms.
The ''Ph.Int.'' is designed to serve all Member States, especially their national and regional regulatory authorities, organizations in the United Nations system, and regional and interregional harmonization efforts, and they underpin important public health initiatives, including the prequalification and procurement of quality medicines through major international entities, such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, and UNICEF.
The monographs published in the ''Ph.Int.'' are established in an independent manner via a consultative procedure and based on international experience.
Monographs on radiopharmaceuticals developed with the International Atomic Energy Agency.
Editions
See also
* ''
European Pharmacopoeia
The ''European Pharmacopoeia'' (''Pharmacopoeia Europaea'', ''Ph. Eur.'') is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the ...
'', another supranational pharmacopoeia
References
External links
*
Procedure for the development of monographs and other texts for The International Pharmacopoeia WHO Technical Report Series No. 992, 2015, Annex 1.
The International Pharmacopoeia: revised concepts and future perspectives WHO Technical Report Series, No. 908, 2003, Annex 2.
Current projects: Monographs and general tests under review/revision for inclusion in the International PharmacopoeiaRadiopharmaceuticalsUpdating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia WHO Technical Report Series, No. 992, 2015, Annex 2.
Trade names of stationary phases found suitable in performing chromatographic tests described in The International Pharmacopoeia
Omitted MonographsWHO Expert Committee on Specifications for Pharmaceutical Preparations
{{DEFAULTSORT:International Pharmacopoeia, The
Pharmacopoeias