This is the Eleventh Edition of The International Pharmacopoeia, published in 2022.

New and revised texts. New and revised texts are introduced for 16 monographs on pharmaceutical substances, 10 monographs on dosage forms, 3 methods of analysis and 3 General monographs on dosage forms.

Omitted texts. Following a decision at the Fifty-fourth meeting of the ECSPP, two monographs and one method of analysis were omitted from the Tenth Edition. Omitted texts are further accessible on the website of The International Pharmacopoeia (https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications/norms-and-standards-for-pharmaceuticals/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.

Online publication. The Eleventh Edition is published online.

ANNEX

NEW TEXTS

Pharmaceutical substances

• Dolutegravir sodium

• Hydroxypropylcellulose, low-substituted

• Remdesivir

• Sodium laurisulfate

• Sodium starch glycolate

• Ulipristal acetate

Dosage forms

• Dolutegravir dispersible tablets

• Dolutegravir, lamivudine and tenofovir disoproxil tablets

• Dolutegravir tablets

• Norethisterone enantate injection

• Remdesivir intravenous infusion

• Ulipristal acetate tablets

General monographs for dosage forms

• Powders for inhalation

REVISED TEXTS

Pharmaceutical substances

• Artenimol

• Bleomycin sulfate

• Dexamethasone sodium phosphate

• Lamivudine

• Medicinal oxygen

• Norethisterone enantate

• Propylthiouracil

• Spectinomycin hydrochloride

• Streptomycin sulfate

• Tenofovir disoproxil fumarate

Dosage forms

• Albendazole chewable tablets

• Dexamethasone phosphate injection

• Lamivudine oral solution

• Levofloxacin tablets

Methods of analysis

• Chromatography

• Dissolution test for oral dosage forms

• General identification tests

General monographs for dosage forms

• Liquid preparations for oral use

• Radiopharmaceuticals

OMITTED TEXTS

Pharmaceutical substances

• Ciprofloxacin

Methods of analysis

• Test for histamine-like substances (vasodepressor substances)