Process Monitoring, microbiological and physicochemical control of the paste form of Flucidal®3 %

Abstract

Our study aimed to verify the compliance of an anti-inflammatory ointment called "FLUCIDAL®3%" with the standards required by the European Pharmacopoeia 2017. FLUCIDAL®3%" is produced by our national pharmaceutical company SAIDAL, located at Dar El Beida, Algiers. The compliance was assessed by controlling its physico-chemical and microbiological properties from raw material (Niflumic Acid (Active ingredient), Sorbic Acid and Nipagine M Sodium (Excipients)) to the finished product. Physico-chemical quality control of semi-finished, finished, and raw materials that demonstrate various essential parameters such as chemical and chromatographic identification tests. Whereas, microbiological control of the final product, includes identifying harmful microorganisms, enumeration of aerobic germs, yeasts, and molds that might affect the drug's quality. The results of our present study are completely consistent with the international standards established by the European Pharmacopoeia. The generic drug FLUCIDAL®3% ointment has a good pharmaceutical quality considering the raw materials used, the absence of pathogenic microorganisms and the quality of the semi-finished and final products