Abstract
ABSTRACT In this study, the quality and safety of three different brands of water for injection marketed in Libya has been evaluated for physical, chemical and microbiological specifications according to well recognized pharmacopoeia guidelines. Samples were collected from different pharmacies and hospitals in Tripoli region and analyzed directly after collection. The Physical tests and appearance were normal for all samples. The chemical evaluation showed normal level of conductivity for all samples. Except S3 it was higher than the limit 1.85 (± 0.07). The chloride and sulphates level were also higher in S3 than the others (0.82 ppm ± 0.01), (0.25ppm ± 0.05) respectively. The total dissolved solids were in accordance to normal level obtained for all samples. All the samples passed the microbial evaluation; the test of coliform was given no growth in all the samples including the expired control sample S4. The deviation of some brands could be due to the lack of applied GMP practice during manufacturing procedures and other source of errors such as the container substance, presence of impurities and ionic interferants from water supply which influence the finished product of WFI. An awareness should be taken by the manufacturers to follow up GMP procedures during all steps of production and GLP in quality control testing. Keywords- Water for injection; Quality Control