Collaborative study for the establishment of the second international standard for vancomycin

Area of Science:

• Pharmacology and Microbiology
• Pharmaceutical Standards and Quality Control

Background:

• The European Directorate for the Quality of Medicines & HealthCare (EDQM) organized an international study.
• The study aimed to establish the World Health Organization (WHO) 2nd International Standard (IS) for Vancomycin.
• The 1st IS for Vancomycin was depleted, necessitating a new standard for continuity.

Purpose of the Study:

• To establish the WHO 2nd International Standard (IS) for Vancomycin.
• To ensure continuity between consecutive batches of the WHO IS for Vancomycin.
• To assign a definitive measure of antimicrobiological activity to the new standard.

Main Methods:

• An international collaborative study involving twelve laboratories from ten countries.
• Estimation of candidate material potency using microbiological assays with sensitive micro-organisms.
• Utilized the European Pharmacopoeia Chemical Reference Standard (CRS) for Vancomycin batch 2, previously calibrated against the 1st IS.

Main Results:

• The candidate material, a freeze-dried preparation, was successfully established as the 2nd IS for Vancomycin.
• The 2nd IS for Vancomycin was adopted by the WHO Expert Committee on Biological Standardisation (ECBS) in 2010.
• An antimicrobiological activity of 109,700 IU per vial was assigned to the 2nd IS.

Conclusions:

• The 2nd IS for Vancomycin has been successfully established and adopted.
• This standard ensures the continued availability of a reliable reference for vancomycin.
• The 2nd IS for Vancomycin is available from the EDQM for use in quality control and research.