Evaluation of Pharmaceutical Excipient Quality from Local Suppliers in Federal Capital Territory, North Central Nigeria

The quality of pharmaceutical excipients sourced from local suppliers significantly influences the safety, stability, and bioavailability of finished dosage forms, yet systematic quality evaluation of excipients procured within Nigeria from domestic distributors remains a poorly documented area of pharmaceutical quality assurance. This study evaluates the quality of five commonly used pharmaceutical excipients, namely microcrystalline cellulose, lactose monohydrate, magnesium stearate, polyvinylpyrrolidone, and talc, sourced from three local pharmaceutical raw material suppliers in the Federal Capital Territory, Abuja, North Central Nigeria. Quality testing is performed against British Pharmacopoeia and United States Pharmacopoeia monograph specifications covering identification tests, physicochemical properties, impurity limits, assay, particle size distribution, flow properties, and microbial limits. Samples from local suppliers are compared with certified reference standards obtained from pharmacopoeial sources. A supplier qualification assessment evaluates documentation, storage conditions, chain of custody, and certificate of analysis authenticity. Statistical analysis determines significant deviations between local supplier-provided excipients and pharmacopoeial specifications. Findings are expected to reveal non-conformances in particle size distribution and moisture content in a proportion of locally sourced materials. A practical supplier qualification protocol and incoming quality inspection procedure are proposed as deliverables applicable to small and medium pharmaceutical manufacturers sourcing excipients within Nigeria. Keywords: pharmaceutical excipients, supplier qualification, British Pharmacopoeia, Federal Capital Territory, quality assurance