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The International Standard for Kanamycin
Journal of Biological Standardization
|January 1, 1986
Summary
The International Standard for Kanamycin now replaces the previous preparation. This new standard, established through a global collaborative study, defines kanamycin potency with 10,345 International Units per ampoule.
Area of Science:
- Pharmacology and Pharmaceutical Science
- Biotechnology
- International Standards and Metrology
Background:
- The International Reference Preparation of Kanamycin has been superseded.
- Establishment of international standards is crucial for consistent drug potency measurement.
Purpose of the Study:
- To introduce and define the new International Standard for Kanamycin.
- To establish a reliable reference for kanamycin potency determination.
Main Methods:
- A collaborative study involving ten laboratories across ten countries was conducted.
- Potency was determined through comparative analysis and consensus.
Main Results:
- The International Standard for Kanamycin has been established.
- Each ampoule of the standard is defined as containing 10,345 International Units (IU) of kanamycin activity.
Conclusions:
- The new International Standard provides a precise and globally recognized measure for kanamycin potency.
- This standardization ensures consistency in pharmaceutical preparations and research involving kanamycin.