Microbiological Assessment of Commercially Available Quinine Syrup and Water for Injections in Dar Es Salaam, Tanzania

Abstract

Purpose: To conduct microbiological assessment of commercially available quinine syrups and water for injection in Dar es Salaam, Tanzania. Methods: This was a cross-sectional study conducted in Dar es Salaam Region. Samples of quinine syrups (QNSs) and water for injection (WFI) of different batches were randomly purchased. Each QNS was inspected for label disclosure, and physicochemical properties were examined by the use of sense of organs and pH meter. Isolation and quantification of microbial contaminants from each sample was preceded by 24 - 48 h incubation at 37 ºC, and the microbial contaminants were expressed as colony forming unit per millilitre (cfu/ml). Microbiological identification of contaminants was performed by examination of colony morphologies and growth characteristics. Gram staining technique, as well as biochemical and serological tests were also conducted for further identification. Albino rabbits were used for the pyrogen test to determine the presence of microbial contamination in WFI. Results: Twenty-four samples of QNS underwent label disclosure, physical-chemical and microbiological assessments. All QNS samples complied with the guidelines and microbial limits as per United States Pharmacopoeia (USP). All batches of WFI were found to be microbiologically contaminated, revealing average microbial counts of 87, 94 and 100 cfu/ml, and this was buttressed by pyrogen test, with the animals showing temperature rise of 1.0, 2.2 and 2.4 ºC, respectively. Conclusion: The QNS products available in the Dar es Salaam market were of good microbial quality. However, WFI products were microbiologically contaminated. We recommend that regulatory authorities in Tanzania should diligently enforce regulatory control of the products to assure consumer safety.