EVALUATION OF THE QUALITY OF DIFFERENT BRANDS OF ASCORBIC ACID IN FREETOWN, SIERRA LEONE
Keywords:Post-market surveillance, Quality control, Vitamin C, Counterfeit, Quality assurance, Unregistered
Objective: This study evaluates the registration status and the quality of nine brands of Vitamin C sold in Freetown, Sierra Leone, using official and non-official methods of analysis.
Methods: The parameters taken into consideration during the study include non-official methods (friability and disintegration) and the official methods (identification test, uniformity of dosage unit, and assay by titrimetric and colorimetric tests). The different brands of vitamin C were selected and classified as registered and unregistered based on the data derived from the National Medicines Regulatory Authority.
Results: One vitamin C product collected was unregistered at the National medicines regulatory authority (Pharmacy Board of Sierra Leone). All nine vitamin C products met the requirements for uniformity of dosage unit. The vitamin C products also conformed to the BP specification for friability and identification test (retention factor). The identification test showed that each brand contained vitamin C (ascorbic acid). The disintegration test was not applicable for chewable tablets. Three of the four non-chewable vitamin C products complied with the BP specification for disintegration, while one failed and did not meet the requirement. The assay results for ascorbic acid using titration and colourimetric method were comparable and appropriate for determining vitamin C. Out of a total of nine samples; seven met the requirement for BP specification (Passed) for assay. In contrast, one product did not meet the BP requirement (failed), and one sample had more vitamin C than the Pharmacopoeia limit.
Conclusion: Periodic quality evaluation and routine checks for pharmaceutical products can ascertain the quality of products, their storage conditions and identify potential counterfeit medications.
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Copyright (c) 2021 MICHAEL LAHAI, EUGENE B. S. CONTEH, AMINATA FREDERICA MANSARAY, JOSEPH AMARA, MOHAMED BAWOH, JAMES P. KOMEH, ALPHAN TEJAN-KELLA, MOHAMED SESAY, WILTSHIRE C. N. JOHNSON
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