Abstract

PHYSICOCHEMICAL AND MICROBIOLOGICAL ASSESSMENT OF SOME COMMERCIALLY AVAILABLE STERILE WATER FOR INJECTION BRANDS IN NIGERIA.

Stanley E. Ukwueze*, Constance G. Okpaleke and Olusayo A. Shorinwa

Abstract

Sterile water for injection used in pharmaceutical and clinical practices are expected to comply with standard specifications. The purpose of this study was to conduct physicochemical and microbiological assessment of commercially available sterile water for injection found in Nigeria market. The physicochemical tests were carried out following standard procedures while the determination of microbiological contaminants of each sample was preceded by 48h incubation at 37oC using plate count agar method. The microbial contaminants were expressed as colony forming unit per millilitre (cfu/ml). Limulus Amoebocyte-lysate (LAL) test was used for pyrogen test to determine the presence of bacterial endotoxin. The results showed that almost all the samples analysed were within the acceptable limits of physicochemical parameters. The tests for bacterial endotoxin showed that the concentration of endotoxin in all the samples were within the acceptable concentration of ≤ 0.25 EU/mL. Sample E, however, did not conform to the local regulatory registration requirement as stipulated by NAFDAC. Although it passed the chemical and microbial tests, but, it fell short of the physical assessment test. In conclusion, the different brands of sterile water for injection analysed met the official specifications. These brands could thus be safely interchanged one in place of another in the reconstitution of pharmaceutical injectable products.

Keywords: Sterile water for injection, physicochemical quality, microbial quality.