Contrôle de la qualité physico-chimique d’un médicament injectable : ( Ayataxim ® 1G)

Abstract

Our work, carried out in the quality control laboratory of the PHARMA.Biotic Céfotaxime sodique unit (Gué d' AIN MILA), concerned the physico-chemical quality control of an antibiotic in INJECTABLE form, namely Ayataxim 1G (Céfotaxime sodique) which is an anti-infectious agent. The purpose of this inspection is to check the quality of the product, and includes a: Control of the physico-chemical quality of raw materials and finished product, highlighting the various indispensable parameters such as identification tests by chemical and chromatographic means, as well as physical tests such as the study of friability and the disintegration of injectqbles. All the results of this study comply fully with the international standards described in the 2015 European Pharmacopoeia, and are reflected in the good quality of the product from the following points of view: