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The second international reference preparation of viomycin
Bulletin of the World Health Organization
|January 1, 1973
Summary
The second international reference preparation for viomycin is now established, redefining the International Unit. This new standard ensures accurate viomycin sulfate assays across different production batches.
Area of Science:
- Microbiology
- Pharmacology
- Analytical Chemistry
Background:
- Viomycin is an antibiotic used in treating tuberculosis.
- Establishing reliable reference standards is crucial for drug quality control and accurate quantification.
- Previous international reference preparations may have limitations in assaying current production batches.
Purpose of the Study:
- To establish a new International Reference Preparation for viomycin.
- To redefine the International Unit of viomycin based on the new standard.
- To evaluate the suitability of the new standard for assaying viomycin sulfate batches.
Main Methods:
- Characterization of the second international reference preparation using material from the US Food and Drug Administration's second Working Standard.
- Redefinition of the International Unit of viomycin.
- Comparative analysis of the new reference preparation against various viomycin sulfate production batches.
Main Results:
- The second international reference preparation was successfully established.
- The International Unit of viomycin was redefined to 0.0012285 mg of the new preparation.
- The new reference preparation demonstrated suitability for assaying diverse viomycin sulfate batches.
Conclusions:
- The second international reference preparation of viomycin is a suitable standard for current production.
- The redefined International Unit provides a more accurate basis for viomycin quantification.
- This advancement supports consistent quality control in viomycin production and use.