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

类白色粉末，有吸湿性，水中易溶

White or almost white powder,Hygroscopic

Freely soluble in water

鉴别

Identification

¹C NMR Spectrum

应符合规定

Should complied

符合规定

complied

HPLC

应符合规定

Should complied

符合规定

complied

平均分子量

Average Molecular Weight

M_W=8000~15000D

12450D

Anti-FⅩa/ Anti-FⅡa

0.9~1.1

1.0

效价potency

Anti-F Xa: ≥ 180 IU/mg

190 IU/mg

核苷酸 Nucleotidic

A260≤0.20

A280≤0.15

A260= 0.18

A280= 0.12

氮含量 Nitrogen content

1.3~2.5%

2.0%

酸碱度pH

5.0~7.5

6.5

蛋白质 Protein

≤2.0%

0.8%

重金属 Heavy Metals

NMT 30ppm

符合规定

complied

干燥失重 Loss on drying

NMT 5.0%

2.4%

细菌内毒素Bacterial endotoxins

0.03USP U

符合规定

complied