The International Pharmacopoeia 2018 Edition 8

January 2019
More details
  • Publisher
    World Health Organization
  • Published
    25th January 2019
  • ISBN 9789241550307
  • Language English

The International Pharmacopoeia comprises a collection of recommended procedures for analysis and specifications for the determination of "pharmaceutical substances" (active pharmaceutical ingredients), excipients and "dosage forms" (general texts and individual finished pharmaceutical products) that is intended to serve as source material for reference or adaptation by any World Health Organization (WHO) Member State wishing to establish pharmaceutical requirements. The pharmacopoeia, or any part of it, shall have legal status whenever a national or regional authority expressly introduces it into appropriate legislation. Further explanation of the role of The International Pharmacopoeia is provided in the section entitled "Scope and function."  

The International Pharmacopoeia is based on advice and decisions from the WHO Expert Committee on Specifications for Pharmaceutical Preparations (ECSPP). All specifications included in this Eighth Edition have been developed following the WHO consultation process and were adopted by the ECSPP. 

This eight edition of The International Pharmacopoeia contains:
- New and revised texts are introduced for 40 monographs on pharmaceutical substances, 13 monographs on dosage forms and one method of analysis.
- As part of the activities to replace mercury salts in titrations of halide salts of weak bases, alternative titrations either with perchloric acid in anhydrous acetic acid or with sodium hydroxide in alcoholic media are introduced in 31 monographs. Two of these new titrations are based on laboratory investigations; the other provisions were based on texts found in the European Pharmacopoeia, which granted permission for reproduction in the Ph.Int. and whose support is gratefully acknowledged.

World Health Organization

World Health Organization is a Specialized Agency of the United Nations, charged to act as the world's directing and coordinating authority on questions of human health. It is responsible for providing leadership on global health matters, shaping the health research agenda, setting norms and standards, articulating evidence-based policy options, providing technical support to countries, and monitoring and assessing health trends.