Eurasian Pharmacopoeia Available

The Eurasian Economic Commission published Volume 1 of the EAEU Pharmacopoeia. This Volume contains 157 general texts and general monographs. Individual monographs are expected to be published in Volume 2 which is currently being elaborated. The EAEU Pharmacopoeia is currently available in Russian language only.

The general texts and general monographs are to some extent harmonized with international Pharmacopoeias (e.g. European Pharmacopoeia, Ph. Eur.). However, there are still some important differences which might become challenging for globally operating companies. The EAEU Pharmacopoeia will come into force on 1st of March 2021.
 
Marketing authorization application dossiers on medicines for human use and medicines for veterinary use shall be brought into compliance with the requirements of EAEU Pharmacopoeia on 1st January 2026 at the latest.

Content of Volume 1 of the EAEU Pharmacopoeia

1. General Notices
1.1.General Statements
1.2. Other Provisions Applying to General Chapters and Monographs                                                     
1.3. General Texts and General Monographs 
1.4. Individual Monographs
1.5. Abbreviations and Symbols
1.6. Units of the International System (SI) used in the Pharmacopoeia and Equivalence with other Units

2. General Chapters  
2.1. Methods of Analysis 
2.1.1. Apparatus
2.1.2. Physical and Physicochemical Methods 
2.1.3. Identification
2.1.4. Limit Tests
2.1.5. Assays
2.1.6. Biological Tests 
2.1.7. Pharmacognostic Tests
2.1.8. Methods used in Pharmacognostic Tests
2.1.9. Pharmaceutical Technical Procedures

2.2. Reagents

2.3. General Texts
2.3.1. General Texts on Microbiology
2.3.1.1. Efficacy of Antimicrobial Preservation
2.3.1.2. Microbiological Quality of Medicinal Products, and Active Substances (Active Pharmaceutical Ingredients, APIs) & Excipients for Pharmaceutical Use
2.3.1.3. Viral Safety 
2.3.1.4. Microbiological Quality of Herbal Medicinal Products, and Herbal APIs & Extracts used in their preparation
2.3.2. Residual Solvents
2.3.3. Use of Alcoholimetric Tables
2.3.4. Polymorphism
2.3.5. Control of Impurities in Substances for Pharmaceutical Use
2.3.6. Characters Section in Individual Monographs
2.3.7. Functionality-related Characteristics of Excipients
2.3.8. Crystallinity
2.3.9. Dosage Form Tests
2.3.9.1. Recommendations for Dissolution Tests 

Annex 4.1. Alcoholimetric Tables


Volume 1 of the EAEU Pharmacopoeia and Index are available at the EAEU website.

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