頁籤選單縮合
題 名 | 101年度國內藥廠自用原料之背景值調查=Backgroud Survey on the Quality of Active Pharmaceutical Ingredients from Pharmaceutical Plants in Taiwan |
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作 者 | 張淑涵; 楊明玉; 王博譽; 陳玉盆; 闕麗卿; 施養志; | 書刊名 | 食品藥物研究年報 |
卷 期 | 4 2013.11[民102.11] |
頁 次 | 頁148-155 |
分類號 | 412.36 |
關鍵詞 | 原料藥; 品質調查; Clindamycin hydrochloride; Ketorolac tromethamine; Losartan potassium; Pentoxifylline; Quality survey; Losartan potassium and pentoxifylline; Active pharmaceutical ingredient; |
語 文 | 中文(Chinese) |
中文摘要 | 101年度原料藥品質調查計畫係以風險評估為原則,選定 clindamycin hydrochloride、 ketorolac tromethamine、losartan potassium、pentoxifylline等原料藥進行調查,並於 2至3月間委由國內 10個縣市衛生局,前往轄區內製藥廠抽驗檢體共 23件,並參照美國藥典第 34版之檢驗規格及方法,進行鑑別、水分、類緣化合物及含量測定等之檢驗,另參考美國藥典第 34版Guide to General Chapters〈467 Residual Solvents〉檢測有機溶劑殘留情形。 23件原料經檢驗品質均符合規定。 |
英文摘要 | In order to survey the quality of active pharmaceutical ingredients in Taiwan, 23 samples were collected from the pharmaceutical manufacturers by local health authorities in Taiwan from February to March in 2012. These samples of active pharmaceutical ingredients belonging to clindamycin hydrochloride, ketorolac tromethamine, losartan potassium and pentoxifylline were analyzed by the method referred to the respective monographs as described in the USP 34, and the results showed that all fulfilled the requirements of USP 34 monographs specification. In addition, the residual solvents were also analyzed in all samples according to USP Guide to General Chapters (467 Residual Solvents), and the results showed that all met the requirements. |
本系統中英文摘要資訊取自各篇刊載內容。