This is the Ninth Edition of The International Pharmacopoeia, published in 2019.

New and revised texts. New and revised texts are introduced for seven monographs on pharmaceutical substances, three monographs on dosage forms and two methods of analysis.

A list of new and revised texts is provided as an annex to this preface.

Omitted texts. Following a decision at the Fifty-third meeting of the ECSPP, nine monographs were omitted from the Eighth Edition. Omitted texts are further accessible on the website of The International Pharmacopoeia ( http://www.who.int/medicines/ publications/pharmacopoeia/en/ ). 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. A list of new, revised and omitted texts is provided as an annex to this preface.

ANNEX

NEW TEXTS

Pharmaceutical substances

• Daclatasvir dihydrochloride
• Estradiol valerate
• Ivermectin
• Moxifloxacin hydrochloride

Dosage forms

• Daclatasvir tablets
• Ivermectin tablets
• Moxifloxacin tablets

REVISED TEXTS

Pharmaceutical substances

• Atazanavir sulfate
• Ethinylestradiol
• Tetracycline hydrochloride

Methods of analysis

• Limit test for heavy metals (2.2.3)
• Dissolution test for solid oral dosage forms (5.5)

OMITTED TEXTS

Pharmaceutical substances

• Artemether tablets
• Didanosine
• Didanosine oral powder
• Didanosine tablets
• Efavirenz oral solution
• Indinavir capsules
• Paediatric didanosine liquid for oral use
• Saquinavir
• Saquinavir tablets
• Saquinavir mesilate
• Saquinavir mesilate capsules
• Stavudine capsules