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The second international standard for tetracycline.
Bulletin of the World Health Organization
|January 1, 1973
Summary
A new international standard for tetracycline (antibiotic) has been established. Its potency is defined as 982 International Units (IU) per milligram, based on global collaborative assays.
Area of Science:
- Pharmacology
- Analytical Chemistry
- Microbiology
Background:
- The first International Standard for Tetracycline became depleted, necessitating a replacement.
- Accurate quantification of tetracycline is crucial for therapeutic efficacy and regulatory compliance.
Purpose of the Study:
- To establish a new International Standard for Tetracycline.
- To define the potency of the second International Standard for Tetracycline in International Units (IU) per milligram.
Main Methods:
- An international collaborative assay involving laboratories from 19 countries.
- Utilized both diffusion and turbidimetric techniques for tetracycline activity measurement.
- Statistical analysis of 281 individual assays to determine agreed potency.
Main Results:
- The second International Standard for Tetracycline was established.
- The defined potency is 982 IU/mg, with confidence limits of 978-986 IU/mg.
- Assay methods yielded statistically valid results, despite some intra- and inter-laboratory variability.
Conclusions:
- The second International Standard provides a reliable reference for tetracycline quantification.
- The established potency ensures consistency in international tetracycline measurements.
- Collaborative efforts successfully defined a new standard for this essential antibiotic.