Variation of Constitution Ratio of Six Major Components in Teicoplanin Preparations.

Abstract

Objectives: Teicoplanin is an antibiotic complex consisting of five closely related components of similar polarity designated A2-1, 2, 3, 4 and 5 and a more polar factor A 3. The variations in the constitution ratio of the six major components were measured to evaluate the validation of teicoplanin preparations.Methods: The concentrations of each component of teicoplanin were measured in 14 lots by high performance liquid chromatography.Results: No significant differences were observed regarding the variation in the constitution ratio between the A 2 and A 3 groups. However, significant differences were found in the A 2-1 component.Conclusions: Variations of the constitution ratio in Teicoplanin preparations may possibly affect the pharmacokinetics of teicoplanin. More care is thus called for during the manufacturing process.