The International Pharmacopoeia. Ninth Edition, 2019. Quality specifications for pharmaceutical substances and dosage forms together with supporting general methods for analysis

The International Pharmacopoeia (Ph. Int.) constitutes a collection of recommended procedures for analysis and specifications for the determination of pharmaceutical substances and dosage forms that is intended to serve as source material for reference or adaptation by any 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 or the role of The International Pharmacopoeia is provided in the paragraphs entitled "Scope and function" at the end of the Preface of this edition. The history of The International Pharmacopoeia dates back to 1874 when the need to standardize terminology and to specify dosages and composition of medicines led to this international pharmacopoeial compendium. The first World Health Assembly in 1948 established with the resolution WHA1.27 the Secretariat of The International Pharmacopoeia and the "Expert Committee on the Unification of Pharmacopoeias of the World Health Organization", which later became the "Expert Committee on Specifications for Pharmaceutical Preparations". Compared to other pharmacopoeias, priority is given to medicines included in the WHO Model List of Essential Medicines and to medicines which are important for WHO health programmes and for which other pharmacopoeias do not offer any test specifications. The quality control specifications published in The International Pharmacopoeia are developed independently via an international consultative procedure. The needs of developing countries are taken into account. The ultimate goal of The International Pharmacopoeia is to provide quality control specifications so as to help enabling access to quality medicines worldwide.
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