檢測項目
Test Iterm
標準規(guī)定
Specification
檢測結果
Results
性狀
Appearance
白色或類白色粉末,有吸濕性,水中易溶
White or almost white powder,Hygroscopic
Freely soluble in water
符合規(guī)定
Complied
鑒別
Identification
13C NMR Spectrum
應符合規(guī)定
Should complied
complied
分子量分布
Molecular Weight
Mw=3800~5000D
4430D
M2000~8000=75.0~95.0%
80.5%
M£2000=12.0~20.0%
13.9%
Anti-FⅩa/ Anti-FⅡa
2.5-4.0
3.61
效價Potency
Anti-FⅩa:90~125IU/mg
115.2 IU/mg
Anti-FⅡa:20~35IU/mg
27.8 IU/mg
溶劑殘留
Residual solvents
DMF
NMT 880 ppm
未檢出
Not Detected
乙醇
NMT 5000 ppm
750 ppm
H2O2殘留
Residual H2O2 in 10% of Aqueous solution
< 0.5 ppm
SO42-/COO-
NLT 1.8
2.1
游離硫
Free Sulfate Content
NMT0.5%
0.2%
氮 Nitrogen
1.8%~2.5%
2.1%
鈉 Sodium
11.3%~13.5%
12.2%
pH (10% Aqueous solution)
6.2~7.7
6.9
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