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The International Standard for Amikacin
Journal of Biological Standardization
|January 1, 1985
Summary
An international standard for amikacin was established through a collaborative study. This standard, crucial for antibiotic assays, defines each ampoule as containing 50,600 International Units of amikacin.
Area of Science:
- Microbiology and Pharmaceutical Science
Background:
- Accurate quantification of antibiotics like amikacin is essential for therapeutic efficacy and safety.
- Establishing international standards ensures consistency in amikacin potency measurements globally.
Purpose of the Study:
- To establish an International Standard for amikacin.
- To define the unitage for amikacin potency.
Main Methods:
- A collaborative assay involving seven international laboratories.
- Statistical analysis of results from participating laboratories to determine the standard's value.
Main Results:
- An International Standard for amikacin was successfully established.
- Each ampoule of the International Standard contains 50,600 International Units (IU) of amikacin activity.
Conclusions:
- The established International Standard provides a reliable reference for amikacin potency determination.
- This standardization facilitates consistent and accurate amikacin drug product testing worldwide.