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中國藥典2000版
CP2000 |
英國藥典1998版
BP1998 |
美國藥典24版
USP24 |
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|
含量 Content(%)
|
98.0-102.0
|
98.0-101.5
|
96.0-101.5
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鑒別 Discrimination
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符合規定 Qualified
|
符合規定 Qualified
|
符合規定 Qualified
|
|
酸度 Acidity(ml)
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≤0.30
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符合規定 Qualified
|
符合規定 Qualified
|
|
氯化物 Chloride(%)
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≤0.003
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≤0.005
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≤0.007
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禁發 硫酸鹽 Sulphate(%)
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≤0.01
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≤0.01
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≤0.01
|
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草酸鹽 Oxalate(%)
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≤0.02
|
/
|
/
|
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還原糖 Reducing sugars
|
/
|
符合規定 Qualified
|
符合規定 Qualified
|
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干燥失重 Loss on drying(%)
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≤0.5
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≤0.5
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≤0.3
|
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灼燒殘渣 Residue(%)
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≤0.1
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≤0.1
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/
|
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重金屬 Heavy metals(%)
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≤0.001
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/
|
/
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砷 As(%)
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≤0.0002
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/
|
/
|
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鎳 Nickel(ppm)
|
/
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≤1
|
/
|
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鉛 Lead(ppm)
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/
|
≤0.5
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≤1
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溶點 Melting point(℃)
|
166-170
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165-170
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166-169
|
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比旋度 Specific optical rotation
|
/
|
+23°-25°
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+137°-145°
|
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山梨醇 Sorbitol
|
/
|
符合規定 Qualified
|
/
|
|
澄清度與顏色 Clarity and color
|
≤1號濁度液 ≤ No.1 turbidimetric solution
|
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