热分析在药品质量评价试验中的应用

H Komatsu, K Yoshii, S Okada
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引用次数: 0

摘要

热分析法可应用于药品质量评价试验。近年来技术的进步和仪器上的数据处理系统加快了该分析技术在药品质量控制领域的应用。本文从日本药典中常用的一种检测方法的角度,报道并讨论了热分析的各种应用技术,如DSC、DTA、TG和DSC杂质分析。进一步说明了该方法在美国药典第23版和英国药典1993版中的应用现状。
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[Application of thermal analysis to quality evaluation tests of drugs].

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.

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