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The international standard for rolitetracycline
Bulletin of the World Health Organization
|January 1, 1973
Summary
An international standard for Rolitetracycline was established, defining the international unit based on collaborative assays. This standardization ensures consistent antibiotic potency measurement across laboratories worldwide.
Area of Science:
- Microbiology
- Pharmacology
- Analytical Chemistry
Background:
- Rolitetracycline is an antibiotic requiring standardized measurement for effective clinical use.
- Previous methods for determining antibiotic potency lacked international consensus.
- Establishing an international standard is crucial for global pharmaceutical quality control.
Purpose of the Study:
- To establish an International Standard for Rolitetracycline.
- To define the international unit (IU) for Rolitetracycline based on a precise mass of the standard.
- To validate the international unit through a collaborative assay.
Main Methods:
- A collaborative assay involving 8 laboratories across 6 countries.
- 133 individual assays were conducted using both diffusion and turbidimetric methods.
- Assays were performed relative to the Working Standard of the USA Food and Drug Administration.
Main Results:
- An International Standard for Rolitetracycline was successfully established.
- The international unit was defined as the activity in 0.001004 mg of the international standard.
- Mean potencies across laboratories showed minimal variation (within 2%), despite using 7 different test organisms and assay types.
Conclusions:
- The established International Standard provides a reliable basis for defining the Rolitetracycline international unit.
- The collaborative assay demonstrated good agreement among laboratories, supporting the validity of the standard.
- This standardization facilitates consistent and accurate potency determination of Rolitetracycline globally.