依诺肝素钠

性状

Appearance

白色或类白色粉末，有吸湿性，水中易溶

White or almost white powder,Hygroscopic

Freely soluble in water

符合规定

Complied

1,6-脱水结构

1,6-anhydro derivative

15-25%

18.9%

鉴别

Identification

¹³C NMR Spectrum

应符合规定

Should complied

符合规定

complied

分子量分布

Molecular Weight

M_w=3800~5000D

4430D

M³₈₀₀₀ <18%

11.6%

M_2000~8000=68.0~82.0%

70.5%

M£₂₀₀₀=12.0~20.0%

17.9%

Anti-FⅩa/ Anti-FⅡa

3.3~5.3

4.14

效价Potency

Anti-FⅩa:90~125IU/mg

115.2 IU/mg

 Anti-FⅡa:20~35IU/mg

27.8 IU/mg

溶剂残留

Residual solvents

DMF

NMT 880 ppm

未检出

Not Detected

乙醇

NMT 5000 ppm

750 ppm

H₂O₂残留

Residual H₂O₂ in 10% of Aqueous solution

< 0.5 ppm

符合规定

complied

SO₄^2-/COO^-

NLT 1.8

2.1

游离硫

Free Sulfate Content

NMT0.5%

0.2%

氮 Nitrogen

1.8%~2.5%

2.1%

钠 Sodium

11.3%~13.5%

12.2%

pH (10% Aqueous solution)

6.2~7.7

6.9