The International Pharmacopoeia (Ph. Int.): Antimalarial Medicines
Proposals for inclusion
It is proposed to include monographs for the following substances and dosage forms. Letters are being sent to known manufacturers of these items inviting them to co-operate in the development of these monographs for publication. Any manufacturers not directly contacted are hereby invited to submit proposals for appropriate specifications and analytical procedures. For further information, please contact:
E-mail: qsm@who.int
APIs
- Piperaquine phosphate
Fixed-dose combinations (FDC)
- Artemether and lumefantrine dispersible tablets
- Artesunate + sulfadoxine and pyrimethamine tablets (used in co-blisters)
- Artesunate and amodiaquine tablets
- Dihydroartemisinin and piperaquine phosphate tablets
Monographs in preparation
Collaborative work is currently being carried out on the development of monographs for the following substances and dosage forms. Draft specifications are circulating for public comment.
- Mefloquine hydrochloride
- International Pharmacopoeia 4th edition 2011 (incl. First and Second Supplements)
- For rapid revisions and important corrections see the Publication page
-
For proposals on sample preparation for the assay of Artemether tablets and Artesunate tablets by high-performance liquid chromatography click here:
pdf, 15kb -
For a general update concerning the monographs for artemisinin derivatives click here:
pdf, 24kb
International Chemical Reference Substances (ICRS)
The International Chemical Reference Substances (ICRS) required to support the monograph specifications in The International Pharmacopoeia are established on the advice of the WHO Expert Committee on Specifications for Pharmaceutical Preparations by the WHO Collaborating Centre for Chemical Reference Substances. Information about the ICRS is available from the centre.
Adopted monographs
The monographs listed here have been adopted by the Expert Committee on Specifications for Pharmaceutical Preparations for addition to the forthcoming issue of the International Pharmacopoeia.