Research Article
Thermostability Comparison of Two Solid States of Cefpiramide
Ming-juan Wang1, Wen-bo Zou1, Jing Xue1, Yan Wang1, Chang-qin Hu1*, Jos Hoogmartens2, Ann Van Schepdael2 and Erwin Adams2
1Department of Antibiotics, National Institutes for Food and Drug control, Beijing, P.R. China
2Katholieke Universiteit Leuven, Faculteit Farmaceutische Wetenschappen, Laboratorium voor Farmaceutische Analyse, Belgium
- *Corresponding Author:
- Chang-qin Hu
Department of Antibiotics
National Institutes for Food and Drug control
Beijing 100050, P.R. China
Tel: +86 1067095308
E-mail: hucq@nicpbp.org.cn
Received date: July 09, 2012; Accepted date: August 21, 2012; Published date: August 28, 2012
Citation: Wang Mj, Zou Wb, Xue J, Wang Y, Hu Cq, et al. (2012) Thermostability Comparison of Two Solid States of Cefpiramide. J Anal Bioanal Tech 3:142. doi: 10.4172/2155-9872.1000142
Copyright: © 2012 Wang Mj, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Abstract
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.
