The International Pharmacopoeia

The International Pharmacopoeia (Ph. Int.) is a collection of quality specifications for pharmaceutical substances and dosage forms, together with supporting general methods of analysis. Its purpose is to serve as source material for reference or adaptation by any World Health Organization (WHO) Member State wishing to establish pharmaceutical requirements.

History

The International Pharmacopoeia was first published by the World Health Organization (WHO) in 1951. It was developed in response to the need for internationally harmonized specifications for pharmaceutical substances and dosage forms. The first edition contained only 28 monographs. Over the years, the publication has grown and the sixth edition, published in 2016, contains more than 400 monographs.

Purpose

The main purpose of The International Pharmacopoeia is to promote and protect public health. It does this by providing internationally recognized and accepted quality standards and specifications for pharmaceutical substances and dosage forms, along with associated analytical methods. These standards are used by regulatory authorities, pharmaceutical industries, and laboratories worldwide to ensure that medicines are of the required quality.

Content

The International Pharmacopoeia contains monographs for pharmaceutical substances and dosage forms, along with test methods, reagents, and apparatus that are necessary for implementing the monographs. The substances included are selected on the basis of worldwide use and importance. The monographs are developed through a consultative process involving WHO Member States, WHO Expert Committees, and partner organizations.

Use

The International Pharmacopoeia is used by national and regional regulatory authorities, pharmaceutical manufacturers, and quality control laboratories. It serves as a basis for national and regional pharmacopoeias and is used to establish national and regional standards for pharmaceutical substances and dosage forms.

See also

• Pharmacopoeia
• World Health Organization
• Pharmaceutical industry
• Quality control

References

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External links

• The International Pharmacopoeia on the WHO website

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