Zeitschrift für analytische und bioanalytische Techniken

Abstrakt

Thermostability Comparison of Two Solid States of Cefpiramide

Ming-juan Wang, Wen-bo Zou Wen-bo Zou, Jing Xue, Yan Wang, Chang-qin Hu, Jos Hoogmartens, Ann Van Schepdael and Erwin Adams

Cefpiramide is susceptible to many factors, including high temperature. Two solid states were observed in cefpiramide: a crystalline form and an amorphous one, and both the accelerated (40°C ± 2°C /75% ± 5% relative humidity (RH)) and stress (60°C ± 2°C / 75% ± 5% RH) stability study demonstrated that the crystalline form of cefpiramide was much more stable than its amorphous form, with related substances, high molecular mass polymers and assay as critical stability indicating parameters. Thermogravimetric analysis (TGA), differential scanning calorimetry (DSC) and water content results indicated that each molecule of crystalline cefpiramide may contain two molecules of crystal water, which can explain its high thermal stability. This study provides valuable information for cefpiramide and its drug products with respect to the improvement of its thermal stability through crystallization.