Quality control and comparative study of the formulation process of two drugs: Paralgan® 500 mg and Doliprane® 500 mg
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Date
2025
Journal Title
Journal ISSN
Volume Title
Publisher
National Higher School of Technology and Engineering-Annaba
Abstract
The aim of this work is a comprehensive study of a generic drug Paralgan®500mg produced by the Algerian pharmaceutical group SAIDAL DAR EL BEIDA.The study covers the various stages in the manufacture of this drug resulting in a pharmaceutical product complying with international standards, and the monitoring of various techniques for validating dosing methods. The results obtained from the physico-chemical analysis of the active ingredient (Paracetamol) comply with recommended standards. A quality comparison between this generic drug and its original drug (Doliprane®500mg) manufactured by the French pharmaceutical group SANOFI clearly shows their equivalence and compliance with international standards. Analysis of accelerated and long-term stability data under various storage conditions (temperature, humidity, light) will provide a better understanding of the factors influencing product durability, and enable us to optimize storage conditions.