12th Edition of The International Pharmacopoeia

Recommendation
8/9 April 2025
Wiesbaden, Germany
Part of PharmaCongress 2025
The 12th Edition of The International Pharmacopoeia is available online. The International Pharmacopoeia (Ph. Int.) contains recommended procedures for analysis and specifications for pharmaceutical substances and dosage forms. According to the WHO (World Health Organization) it is intended to serve as source for reference or adaptation by any WHO Member State. It has legal status, whenever a national or regional authority refers to it in appropriate legislation.
12th Edition of the Ph. Int.
The World Health Organization develops and promotes international standards for pharmaceutical products, in support of efforts to increase access to quality-assured medicines for all, and to safeguard patients from substandard and falsified medicines. The International Pharmacopoeia is a key output of this work.
New and revised texts are therefore introduced for
- 11 monographs on pharmaceutical substances,
- 12 monographs on dosage forms,
- 3 methods of analysis,
- 2 texts for inclusion in the Supplementary information section, and
- 1 general monograph on dosage forms (Liquid preparations for oral use).
Amongst others, the revision includes new monographs on linezolid, molnupiravir, nirmatrelvir, and tests for EG and DEG (ethylene glycol and diethylene glycol) in liquid preparations for oral use.
For more information please see The International Pharmacopoeia, 12th Edition.
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