Abstract The control of the pharmaceutical raw material is essential before the formulation to ensure the safety of the drug treatment. This study describes an application of Physico-Chemical Control of Amoxicillin Sodium quality according to the requirements of the European Pharmacopoeia 8th edition. The Amoxicillin Sodium raw material appears as substantially white powder, very hygroscopic, soluble in water and ethanol but very slightly soluble in acetone. Its melting point, pH determination and specific rotatory power are respectively: 207.8 °C, 8.82 and +269. Its solution develops a dark yellow color with sulfuric acid and formaldehyde. The Determination of water content is 2.75 % and HPLC Determination of Content is 97,6 %. The Amoxicillin sodium controlled is conforming to the tests required by the European Pharmacopoeia. Due to the lack of availability of standards, the analysis of related impurities hasn’t been carried out.
Keywords Pharmaceutical Raw Material, European Pharmacopoeia, HPLC, Content.