Microbiological and Physicochemical Analyses of Pharmaceutical Raw Materials Used in Some Pharmaceutical Products

Abstract

This study was carried out to investigate the microbiological and physicochemical characteristics of pharmaceutical raw materials used in some non-sterile preparations. A total of 16samples of pharmaceutical raw materials and 3 formulated non sterile preparations were subjected to microbial limit test, isolation and characterization of microbial contaminants and physicochemical analysis. From the result there were no bacterial contamination in all samples analyzed but 7 out of the 16 raw materials had fungal count ranging from 0.30±1.50 x10² cfu/ml (glycerol) to 1.61±0.83 x 10²cfu/ml (raspberry juice) The formulated paracetamol elixir recorded the highest fungal count (3.33 ± 1.43 x 10²cfu/ml) while pediatric ferrous sulphate mixture had the least fungal count (0.33 ± 0.04 x 10²cfu/ml). The fungal isolates and their frequency of occurrence in the raw materials were Aspergillus niger (25%), Rhizopus stolonifer (6.25%) and Candida albicans (12.50%). Similarly, the fungal isolates from the formulated oral preparations were Aspergillus niger (100%), Rhizopus stolonifer (33.33%) and Candida albicans (33.3%). The physicochemical characteristics of the various raw materials and formulated preparations revealed the colour, odour, pH, density, total solids and moisture content of the various samples. The study has revealed that the microbiological and physicochemical characteristics of pharmaceutical raw materials determine their suitability for pharmaceutical preparations. Most of the analyzed samples were well within the stipulated limits of the United States Pharmacopeia. It is therefore advised that pharmaceutical raw materials be evaluated at all stages of the production process.