Physicochemical Characterization and Bibliometric Analysis of Malaysian Paracetamol Tablets in Compliance With MS ISO/IEC 17025 Standards.

Ensuring the quality and safety of pharmaceutical products is essential for public health, particularly for widely used medications such as paracetamol. This study evaluated the physicochemical characteristics, dissolution performance, chromatographic quantification, heavy metal content, and microbiological quality of three paracetamol tablet brands, namely Dyna, Homecare Poro, and Paracil, under MS ISO/IEC 17025-accredited laboratory conditions, complemented by a bibliometric analysis of global research trends in paracetamol quality control. Physicochemical assessments included uniformity of weight, hardness, friability, and disintegration time. Dissolution testing was performed using the ERWEKA paddle method at 37°C ± 0.5°C and 50 rpm to assess the rate and extent of drug release. The dissolution profiles showed variable release patterns among the tested brands, with Dyna achieving 100% drug release at 60 min, whereas Homecare Poro and Paracil showed lower release values at the same time point. Ultra high performance liquid chromatography (UHPLC) analysis showed distinct paracetamol peaks for all three brands, with Dyna producing the highest peak area response, followed by Homecare Poro and Paracil. Heavy metal analyses for lead (Pb), cadmium (Cd), mercury (Hg), and arsenic (As) were performed using flame atomic absorption spectrometry (FAAS) and flow injection atomic spectroscopy (FIAS). Microbiological tests included total aerobic microbial count (TAMC), total yeast and mold count (TYMC), bile-tolerant gram-negative bacteria, Escherichia coli, Salmonella spp., and Staphylococcus aureus. All tested parameters complied with British Pharmacopoeia (BP) and Drug Registration Guidance Document (DRGD) standards. Bibliometric analysis of 2191 Scopus-indexed publications from 2010 to 2025 indicated strong research focus on dissolution, pharmaceutical analysis, and quality control, whereas heavy metal testing, microbiological evaluation, and accreditation-based studies remain limited. This integrated analytical-bibliometric approach confirms product compliance and highlights the need for robust accredited testing frameworks in pharmaceutical quality assurance.