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抗生素Cephalexin原料藥之品質調查

Quality Survey of Cephalexin Active Pharmaceutical Ingredient in Taiwan

摘要


為暸解台灣地區抗生素Cephalexin原料藥之品質狀況,經洽請台北市政府衛生局、高雄市政府衛生局及各縣市政府衛生局,於民國94年3月至8月間,赴轄區內Cephalexin製劑製造廠、原料藥製造廠及輸入代理商抽驗檢體共計27件。參照中華藥典第五版(Ch. P. V)。美國藥典第27版(USP 27)。歐洲藥典第5.0版(EP 5.0)及英國藥典2000年版(BP 2000)之檢驗方法進行檢測,其結果均符合藥典規定。

關鍵字

Cephalexin 原料藥

並列摘要


In order to survey the quality of Cephalexin active pharmaceutical ingredients (API), 27 samples were collected from different counties and cities throughout Taiwan from March to August, 2005. Samples were analyzed by the method described in the Ch. P. V, USP 27, EP5.0 and BP 2000. The results showed that all cephalexin samples met the pharmacopeia requirements.

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