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Biological standards and pharmacopoeias
Annali Dell'Istituto Superiore Di Sanita
|January 1, 1975
Summary
Biological substance potency requires reference standards for accurate measurement due to limitations in physical or chemical analysis. Establishing national standards calibrated to international units ensures consistent potency assessment and conserves master standards.
Area of Science:
- Biotechnology
- Pharmacology
- Biochemistry
Background:
- Potency of biological substances often cannot be determined by physical or chemical means.
- Biological tests, especially those involving animals, have inherent variables.
- Accurate potency assessment is crucial for controlling biological substances.
Purpose of the Study:
- To highlight the importance of standards in controlling biological substances.
- To explain the necessity of comparing biological activity against reference preparations.
- To discuss criteria for quality preparations as standards and their applications.
Main Methods:
- Comparing the activity of an unknown biological substance with a standard preparation within a single test.
- Ensuring the biological activity of the standard mirrors that of the products it controls.
- Establishing European or National Standards calibrated in International Units.
Main Results:
- International Standards, held by the World Health Organization, serve as master standards.
- National or European Standards are calibrated against International Units to conserve master stocks.
- Criteria for suitable standard preparations and examples of their use are presented.
Conclusions:
- Standards are indispensable for the reliable control and potency determination of biological substances.
- Single-test comparisons and consistent biological activity are essential for valid standardization.
- The establishment of calibrated national standards is vital for preserving international reference materials.