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The international standard for colistin
Bulletin of the World Health Organization
|January 1, 1973
Summary
An International Standard for Colistin was established, defining the International Unit based on collaborative assays. This standard ensures consistent colistin activity measurement globally.
Area of Science:
- Pharmacology
- Microbiology
- International Standards
Background:
- Colistin is a critical antibiotic for treating multidrug-resistant Gram-negative infections.
- A standardized method for measuring colistin activity is essential for accurate dosing and therapeutic efficacy.
Purpose of the Study:
- To establish an International Standard for colistin.
- To define the International Unit (IU) for colistin activity.
Main Methods:
- A collaborative assay involving nine laboratories across six countries was conducted.
- The assay utilized a colistin preparation manufactured in Japan.
Main Results:
- The International Unit for colistin was defined as the activity present in 0.00004878 mg of the standard preparation.
- The Japanese-manufactured standard material demonstrated compositional similarity to European sources.
- The established standard is suitable for assaying colistin from current manufacturing sources.
Conclusions:
- An International Standard for colistin has been successfully established.
- The defined International Unit provides a basis for global colistin activity standardization.
- The standard is appropriate for use with colistin derived from various manufacturing origins.