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檢驗(yàn)項(xiàng)目
T e s t I t e m
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檢驗(yàn)標(biāo)準(zhǔn)
T e s t S t a n d a r d
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檢驗(yàn)結(jié)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(jié)晶或粉末
(White crystal or powder)
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合格
(Conform)
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含量
(Assay)
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≥99.0%
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99.0%
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澄清度實(shí)驗(yàn)
(Appearance of solution)
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應(yīng)符合規(guī)定
(Comply with the standard)
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合格
(Conform)
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氯化物
(Chloride)
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≤0.01%
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0.01%
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硫酸鹽
(Sulphates)
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≤0.05%
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0.048%
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酒石酸鹽
(Tartaric acid salt)
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應(yīng)符合規(guī)定
(Comply with the standard)
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合格
(Conform)
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易炭化物
(Easy carbonized content)
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應(yīng)符合規(guī)定
(Comply with the standard)
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合格
(Conform)
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干燥失重
(Loss on drying)
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10.0-13.0%
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合格
(Conform)
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鈣鹽或草酸鹽
(Calcium salt and oxalic acid salt)
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≤0.005%
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0.005%
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鐵鹽
(Iron)
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≤0.001%
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0.0008%
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重金屬
(Heavy metal)
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≤0.0005%
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0.0005%
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砷
(Arsenic)
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≤0.0001%
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0.0001%
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細(xì)菌內(nèi)毒素
(Bacterial endotoxins)
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<0.25EU
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合格
(Conform)
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結(jié)論(Conclusion):符合醫(yī)藥級(jí)之規(guī)定(The above product complies with Pharmaceutical Grade)
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