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" below. A summary of the history and major changes in the previous versions is provided in the folder "Background to previous editions of The International Pharmacopoeia".
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. New and revised texts.
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.