This is the Tenth Edition of The International Pharmacopoeia, published in 2020.

New and revised texts. New and revised texts are introduced for ten monographs on pharmaceutical substances, eight monographs on dosage forms, one methods of analysis and two text for the supplementary information section.

Omitted texts. Following a decision at the Fifty-fourth meeting of the ECSPP, two monographs and one method of analysis were omitted from the Ninth Edition. Omitted texts are further accessible on the website of The International Pharmacopoeia (https://www.who.int/teams/health-product-and-policy-standards/pharmacopoeia). Users of these texts may note that the documents are provided for information; they will neither be updated or revised, nor will the prescribed International Chemical Reference Substances (ICRS) be further monitored for the analytical purpose mentioned in the monograph. Users will need to ensure that the described active pharmaceutical substances or dosage forms comply with current rules and regulations governing medicines in their respective territories.

ANNEX

NEW TEXTS

Pharmaceutical substances

• Sofosbuvir

Dosage forms

• Ciprofloxacin tablets
• Pyrimethamine tablets
• Sofosbuvir tablets

Supplementary information

• Polymorphism
• Procedure for the elaboration, revision and omission of monographs and other texts for The International Pharmacopoeia

REVISED TEXTS

Pharmaceutical substances

• Capreomycin sulfate
• Ciprofloxacin hydrochloride
• Doxycycline hyclate
• Kanamycin acid sulfate
• Kanamycin monosulfate
• Levofloxacin hemihydrate
• Moxifloxacin hydrochloride
• Pyrimethamine
• Water for injections

Dosage forms

• Capreomycin for injection
• Doxycycline capsules
• Doxycycline tablets
• Ivermectin tablets
• Levofloxacin tablets

Methods of analysis

• Capillary electrophoresis (1.17)

OMITTED TEXTS

Pharmaceutical substances

• Chlorpheniramine hydrogen maleate

Dosage forms

• Chlorpheniramine hydrogen maleate tablets

Methods of analysis

• Undue toxicity (3.7)