熱分析法による医薬品の品質評価

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書誌事項

タイトル別名
  • Quality Evaluation of Drug Substances by Thermal Analysis.
  • カイセツ ネツ ブンセキホウ ニ ヨル イヤクヒン ノ ヒンシツ ヒョウカ

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抄録

In the Supplement II to the Japanese Pharmacopoeia 13th (1999), “Thermal Analysis” has been newly adopted as a General tests and Methods. Thus in this text, summary of the method was explained, and then it was considered how the method can be applied to the quality evaluation of materials such as starting materials, intermediates and active pharmaceutical ingredients.<br>The quality of drug substance can be specified by various physico-chemical tests and methods. Among many test items, the method can be applied to test items such as “Description”, “Loss on Drying” or “Water Content” and “Purity Test for Related Substances”. In the respective test item it was explained what is the meaning of each test item for the quality evaluation of drug substance and what types of application can be envisaged with, based on appropriate experimental examples.<br>Furthermore it was also considered how the thermal analysis method is treated in the US Pharmacopeia (USP) and/or European Pharmacopoeia (EP).

収録刊行物

  • 熱測定

    熱測定 27 (5), 242-249, 2000

    日本熱測定学会

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