Microbiological Quality Control of Locally Manufactured Oral Rehydration Salts in Katsina, Katsina State

Oral rehydration salts (ORS) are essential medicines used extensively in managing acute diarrheal diseases, particularly among children under five in resource-limited settings. The microbiological quality of locally manufactured ORS sachets in Katsina State, North West Nigeria, was evaluated in this study. Forty ORS sachets from four local manufacturers registered with NAFDAC were collected and subjected to microbiological testing following the British Pharmacopoeia (BP) and United States Pharmacopeia (USP) guidelines. Parameters assessed included total aerobic microbial count, total combined yeast and mold count, and specific organism testing for E. coli, Salmonella species, Pseudomonas aeruginosa, and Staphylococcus aureus. Physicochemical attributes including pH and osmolarity were also measured to contextualize biological findings. Results showed that 30 percent of samples failed one or more microbiological criteria. E. coli was detected in 15 percent of samples, while Salmonella species were isolated from 10 percent. Total microbial counts in 25 percent of samples exceeded USP limits by two log units. Failure rates were higher in products from manufacturers with lower production volumes and less sophisticated quality control infrastructure. Given the use of ORS in already-vulnerable pediatric patients, these contamination levels represent a direct risk of therapeutic harm. Improved GMP compliance, raw material testing, and post-market surveillance are urgently recommended. Keywords: oral rehydration salts, microbiological quality, NAFDAC, Katsina, GMP compliance.