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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

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。

關鍵字

原料藥 Acarbose Meloxicam 品質調查

並列摘要


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 analyzed for 9 residue solvents. The results showed that all met the requirements of USP 32 specification.

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