Report concerning results of proficiency testing laboratory on assay of tobramycine and nystatin by microbiological method
Journal Title: Medicamentul Veterinar / Veterinary Drug - Year 2013, Vol 7, Issue 1
Abstract
The present study describes the results obtained by the Microbiological Control Laboratory from Institute for Control of Biological Products and Veterinary Medicines after participating in the proficiency testing scheme study on microbiological assay of nystatin and tobramycin. The proficiency testing scheme was organized by European Directorate for the Quality of Medicines and Health Care. The microbiological method consisted of a cylinderplate agar diffusion assay using Bacillus subtilis ATCC 6633 for tobramycin and Saccharomyces cerevisiae for nystatin as the test microorganism. The means of results were 108.70 % of label claim for nystatin and 104.70% of label claim for tobramicin. The Z scores were 0.14 for tobramycin and 1.40 for nystatin, the assigned value used for booth samples was 105.4% for tobramycin and 101.7% for nystatin. The performance of Microbiological Control Laboratory was very good for both samples.
Authors and Affiliations
Simona Sturzu, Daniela Tirsinoaga, Ioana Tihulca, Alina Draghici
Keywords
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