DETERMINATION OF THE CONFORMITY OF PARACETAMOL 500MG TABLETS AT THE NATIONAL HEALTH LABORATORY

Paracetamol is the most widely used analgesic, alone or in combination with other active ingredients. The falsification and fraudulent manufacture of medicines is a long-standing problem, greatly exacerbated by modern manufacturing techniques and trade. Over the past decade, ineffective medicines have compromised the treatment of many life-threatening diseases in resource-limited countries. The objective of our study was to assess the conformity of 500 mg paracetamol tablets, collected from the People's Pharmacy of Mali (PPM). This was a qualitative and quantitative analytical study conducted from May to July 2025 at the LNS Medicines Quality Control Service. We used the 95.0 to 105.0% specification of the British Pharmacopoeia (BP 2025).The parameters were: Disintegration, Thin Layer Chromatography (TLC), Infrared (IR) Spectroscopy, and UV Visible Spectrophotometry. Of the 20 batches analyzed, 7 were non-compliant due to the absence of a manufacturing date on the primary packaging, which constitutes a regulatory defect. The other batches were all compliant. The dosage of the active ingredient was compliant for all 20 batches, within the limits set by the British Pharmacopoeia (95.0% to 105.0%).