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檢驗項目
T e s t I t e m
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檢驗標準
T e s t S t a n d a r d
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檢驗結果
T e s t r e s u l t
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性狀
(Characters)
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白色結晶性粉末
(White crystalline powder)
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合格
(Conform)
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含量
(Assay)
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98.5%~101.0%
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99.2%
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澄清度實驗
(Appearance of solution)
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應符合規定
(Comply with the standard)
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合格
(Conform)
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酸堿度
(Acidity or alkalinity)
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應符合規定
(Comply with the standard)
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合格
(Conform)
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氯化物
(Chloride)
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0.045%
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0.001%
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鈣
(Calcium)
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0.045%
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0.002%
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鐵
(Iron)
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0.009%
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0.001%
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鎂
(Magnesium)
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0.02%
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0.01%
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重金屬
(Heavy metal)
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0.0045%
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0.001%
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干燥失重
(Loss on drying)
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0.5%
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0.2%
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結論(Conclusion):符合醫藥級之規定(The above product complies with Pharmaceutical Grade)
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