頁籤選單縮合
題名 | 九十九年國內藥廠自用原料背景值調查=Backgroud Survey on the Quality of Active Pharmaceutical Ingredients from Pharmaceutical Plant |
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作者姓名(中文) | 張淑涵; 楊明玉; 王博譽; 陳玉盆; 羅吉方; | 書刊名 | 食品藥物研究年報 |
卷期 | 2 2011.11[民100.11] |
頁次 | 頁231-236 |
分類號 | 418.43 |
關鍵詞 | 原料藥; 品質調查; Acarbose; Meloxicam; Active pharmaceutical ingredient; Quality survey; |
語文 | 中文(Chinese) |
中文摘要 | 為瞭解國內西藥製劑廠所使用自用原料藥之品質情形,確保民眾用藥安全,99年開始進行國內藥廠專案進口原料藥之品質調查,以掌握產品品質狀況。 99年度之原料藥品質調查選定Acarbose及Meloxicam品目,依據美國藥典第32版之檢驗規格及方法進行鑑別、比旋光度、不純物限量、殘留溶劑限量及含量測定等項目之檢驗,並於7月至9月委請衛生局赴藥廠實地抽樣共計20件,經檢驗20件檢體之品質均符合規定。 |
英文摘要 | In order to understand the quality of active pharmaceutical ingredients from pharmaceutical plant in Taiwan, 20 samples were collected from the imported pharmaceutical dosage manufacturers by local health officers in Taiwan from July to September in 2010. These samples were analyzed for acarbose and meloxicam by referring to the respective monographs as described in the USP 32, and also analysed for 9 residue solvents. The results showed that all met the requirements of USP 32 specification. |
本系統之摘要資訊系依該期刊論文摘要之資訊為主。