Komatsu H, Yoshii K, Okada S
Eisei Shikenjo Hokoku. 1996(114):147-9.
Thermal analysis method can be applied to the quality evaluation tests of drugs. Recent advances in the technology and the data-processing system on the apparatus have accelerated the utilization of this analytical techniques in the field of drug quality control. In this report, various application techniques of the thermal analysis such as DSC, DTA, TG and the impurity analysis by DSC, were reported and discussed from the viewpoints of a general test in the Japanese Pharmacopoeia. Further the present situations of this analytical method in the US Pharmacopoeia 23 and the British Pharmacopoeia 1993 are also explained.
热分析方法可应用于药物的质量评估测试。该技术及其仪器数据处理系统的最新进展加速了这种分析技术在药物质量控制领域的应用。在本报告中,从日本药典的一般测试角度,报告并讨论了热分析的各种应用技术,如差示扫描量热法(DSC)、差热分析法(DTA)、热重分析法(TG)以及通过DSC进行的杂质分析。此外,还介绍了美国药典23版和英国药典1993版中这种分析方法的现状。