- 期刊
102年度國內藥廠原料之品質背景值調查
Background Survey on the Quality of Active Pharmaceutical Ingredients from Pharmaceutical Plants in Taiwan
摘要
102年度原料藥品質調查研究係以風險評估為原則，選定Carvedilol、Fexofenadine hydrochloride及Rifampin成分之原料藥進行調查，並於3至5月間委由國內8個縣市衛生局，前往轄區內製藥廠抽驗檢體共18件，包括6件Carvedilol、7件Fexofenadine hydrochloride及5件Rifampin，並參照美國藥典第35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項目之檢驗，另參考美國藥典第35版Guide to General Chapters〈467 Residual Solvents〉檢測有機溶劑殘留情形。檢驗結果，18件檢體中1件Rifampin含量及1件Rifampin含量與其類緣化合物Rifampin quinone限量不合格，其餘4件Rifampin、6件Carvedilol及7件Fexofenadine hydrochloride之檢驗結果均合格。本調查報告結果將提供相關單位行政管理之參考。
並列摘要
In order to survey the quality of active pharmaceutical ingredients in Taiwan, 18 samples were collected from the pharmaceutical manufacturers by 8 local health authorities in Taiwan from March to May in 2013. These samples included 6 containing Carvedilol,7 containing Fexofenadine hydrochloride and 8 containing Rifampin, were analyzed by the specifications method referred to the respective monographs as described in the USP 35. The results showed except one Rifampin sample failed to meet the requirement of assay and related substance of Rifampin quinone, and another Rifampin sample failed to meet the requirement of assay, all the others fulfilled the requirements of USP 35 monograph specifications. In addition, we also analyzed the residual solvents in all samples according to USP Guide to General Chapters (467 residual solvents), and the results showed that all met the requirement.
延伸閱讀
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