Comparative Study of Chloramphenicol 500 mg Capsules on the Mongolian Pharmaceutical Market According to Pharmacopoeial Standards

Abstract

Background: By supporting the production of domestic substitutes for essential medicines listed in Mongolia’s national drug policy, pharmaceutical companies are enabled to ensure product quality assurance, conduct safety monitoring and research, and carry out quality control and certification of medicines. Therefore, ongoing quality assessment is essential to ensure that domestically manufactured medicines meet established standards before they can replace imported alternatives. This study seeks to assess whether the quality parameters of both locally produced and imported 500 mg Chloramphenicol capsules available in the Mongolian pharmaceutical market conform to the requirements of the Mongolian National Pharmacopoeia. Aim: To compare and study the quality parameters of certain domestically manufactured and imported chloramphenicol capsule formulations in accordance with pharmacopoeial standards Materials and Methods: This study examined four types of 0.5 g Chloramphenicol capsules: three domestically produced (X1, X2, X4) and one imported (X3). The evaluation included tests for identification, average weight, weight variation, dissolution, disintegration, thin-layer chromatography (TLC), assay, high-performance liquid chromatography (HPLC), and microbiological analysis, following the standards outlined in the Mongolian National Pharmacopoeia 2011 (MNP 2011), United States Pharmacopeia 39 (USP 39), Japanese Pharmacopoeia 18 (JP 18), and Chinese Pharmacopoeia 2020 (ChP 2020). Statistical analysis was performed using SPSS version 22.0. Results: The purity analysis of samples X1, X2, X3, and X4 indicated that all met the applicable standards. Among them, X1 and X3 complied with pharmacopoeial requirements for identification, weight variation, dissolution, active ingredient assay, and thin-layer chromatography (TLC). In contrast, X4 failed the identification test and had a low active ingredient content, while both X2 and X4 exhibited inadequate dissolution, suggesting non-compliance with standard requirements. Furthermore, high-performance liquid chromatography (HPLC) analysis based on USP criteria revealed that neither X1 nor X3 met the specified limits. Conclusion: Among the four Chloramphenicol capsule samples analyzed, only X1 and X3 met the pharmacopoeial standards. The non-compliance of X2 and X4 underscores the importance of continuous monitoring and quality assessment of domestically manufactured pharmaceuticals.