- 期刊
100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
摘要
100年度原料藥品質調查計畫係以風險評估為原則，選定acetaminophen、amoxicillin及dipyridamole成分之原料藥進行調查，並於6至7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21件，檢驗項目參照美國藥典第32版之檢驗規格及方法，進行鑑別、雜質檢查、層析法純度檢查及含量測定等之檢驗，並參考美國藥典第32版Guide to General Chapters〈467 Residual Solvents〉檢測有機溶劑殘留情形。調查結果，5件經檢驗含二氯甲烷（Methylene chloride）超過美國藥典殘留溶劑限量規範（600 ppm），其餘部分皆符合藥典規範。
並列摘要
In order to survey the quality of active pharmaceutical ingredients in Taiwan, 21 samples were collected from the pharmaceutical manufacturers by local health authorities in Taiwan from June to July in 2011.These samples of active pharmaceutical ingredients belonging to acetaminophen, amoxicillin and dipyridamole were analyzed by the method referred to the respective monographs as described in the USP 32, and the results showed that all fulfilled the requirements of USP 32 monographs specification. In addition, we also analyzed the residual solvents in all samples according to USP Guide to General Chapters (467 Residual Solvents), and the results revealed that 5 samples failed to meet the general specification of methylene chloride.