Determination of Residual Solvents in Bulk Pharmaceuticals by Thermal Desorption/Gas Chromatography/Mass Spectrometry
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概要
- 論文の詳細を見る
Thermal desorption (TD) techniques followed by capillary GC/MS were applied for the analysis of residual solvents in bulk pharmaceuticals. Solvents desorbed from samples by heating were cryofocused at the head of a capillary column prior to GC/MS analysis. This method requires a very small amount of sample and no sample pretreatment. Desorption temperature was set at the point about 20℃ higher than the melting point of each sample individually. The relative standard deviations of this method tested by performing six consecutive analyses of 8 different samples were 1.1 to 3.1%, and analytical results of residual solvents were in agreement with those obtained by direct injection of N, N-dimethylformamide solution of the samples into the GC. This novel TD/GC/MS method was demonstrated to be very useful for the identification and quantification of residual solvents in bulk pharmaceuticals.
- 公益社団法人日本薬学会の論文
- 2000-12-01
著者
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Hashimoto K
Kyoto Pharmaceutical University
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Hashimoto Keiji
Nagahama Institute Of Bio-sciences And Technology
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FUJIWARA Yasuhiro
Kyoto Pharmaceutical University
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HASHIMOTO Keiji
Kyoto Pharmaceutical University
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Fujiwara Y
Kyoto Pharmaceutical University
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Saito Yuka
Kyoto Pharmaceutical University
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Hashimoto K
Nagahama Institute Of Bio-sciences And Technology
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Urakami Koji
Analysis & Quality Control Department Takeda Chemical Industries Ltd.
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UMEMOTO Kazuichi
Analysis & Quality Control Department, Takeda Chemical Industries, Ltd.
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GODO Masayuki
Analysis & Quality Control Department, Takeda Chemical Industries, Ltd.
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WATANABE Chuichi
Frontier LAB, Co., Ltd.
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Godo Masayuki
Analytical Development Laboratories Takeda Chemical Industries Ltd.
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Umemoto K
Analytical Development Laboratories Takeda Chemical Industries Ltd.
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Watanabe C
Frontier Laboratories Ltd.
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HASHIMOTO Keiji
Kyoto College of Pharmacy
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