Approche analytique intégrée pour l’évaluation de la qualité et de la traçabilité de la production de PARAMOL 1000 mg

Abstract

This study focused on the quality control and stability testing of the medicinal product PARAMOL® 1000 mg, whose active ingredient is paracetamol. The main objective was to evaluate the compliance of the finished product with the requirements of the Britch Pharmacopoeia through various pharmaceutical, analytical, microbiological, and stability tests. The results obtained showed that the product has satisfactory overall quality. Pharmaceutical quality control tests (mass uniformity, hardness, friability, disintegration, and tablet divisibility) complied with the specifications and demonstrated good control of the manufacturing process. Dissolution and assay tests confirmed adequate paracetamol release and a content that complies with Pharmacopoeial specifications. Identification analyses (TLC and UV–Visible spectroscopy) and impurity testing by HPLC confirmed the presence of paracetamol and an impurity profile that complies with regulatory requirements. Microbiological testing demonstrated the absence of pathogenic microorganisms. Finally, the stability study demonstrated that the product retains its properties under the storage conditions studied.