Microbiological Assay of Two Selected Products of Ceftriaxone Powder for Injection from Pharmaceuticals' Market in Sudan

Abstract

Background: Different techniques have classically been used to evaluate and assure the quality of medicines circulated on the market; one of the commonly uses is chemical analysis. However, some evidence has shown that there are other important indicators (e.g. bioequivalence, relative potency, etc.) that should also be considered when evaluating the quality of pharmaceutical products.
Materials and Methods: A microbiological assay was conducted to compare the relative potency of two Ceftriaxone products (with a third one used as standard product) from the market using 3 reference bacteria including Streptococcus pneumoniae, Klebsiella pneumoniae and Staphylococcus aureus. Serial dilutions were made with the corresponding 1, 4, 8, 16 and 32-fold Minimum Inhibitory Concentration (MIC) of Ceftriaxone against the bacteria under investigation.
Results: The relative potency of one product compared to the standard product was estimated to be within the acceptable range of bioequivalence (89.6%), while the other product showed unacceptable relative potency (72.3%).
Conclusions: The microbiological assay is an effective and simple method for comparing the equivalency of injectable products. A complaint reporting system about quality and effectiveness problems needs to be considered as a priority source of such information to inform decision-makers.

Keywords: Microbiological assay, Ceftriaxone, quality assurance, relative potency and genericmedicines.