Heparin sodium


CAS NO. : 9041-08-1

Pharmacopoeia standard:EP / USP

HS CODE : 3001.9010.00

File service :Chinese GMP / DMF


SourcePorcine intestine mucosa.

CharactersWhite or almost white powder, highly hygroscopic.

ProcessHeparin sodium is extracted from healthy porcine intestine mucosa.

product details



Test Items

Company Specification

EP

USP

Characters

White or almost white powder, highly hygroscopic

Identification

Thrombotest: Conforms

Chromatographic identity: Conforms

1H NMR Spectrum: Conforms

1H NMR Spectrum: Conforms

Liquid Chromatography: Conforms

Weight-average molecular weight: 15000~19000

Sodium: Conforms

Sodium: Conforms

Anti-factor Xa to anti-factor IIa ratio:0.9~1.1

Anti-factor Xa to anti-factor IIa ratio:0.9~1.1

Tests

Clarity and color

Clarity: Clear, Color: by 5 or better

————

Nitrogen

1.5~2.5%(dry substance)

1.3~2.5%(dry substance)

Nucleotidic impurities

A260 ≤ 0.15(4mg/ml)

≤ 0.1(w/w)

Related substances

Conforms

————

Limit ofgalactosamine in total hexosamine

————

≤ 1.0%

Oversulfated chondroitin sulfate

————

Conforms

pH

5.5~8.0(1%)

5.5~7.5(1%)

Loss on drying

≤ 8.0%(60Dry in Vacuum, 3h

≤ 5.0%(60Dry in Vacuum, 3h

Residue on ignition

————

28.0%~41.0%

Bacterial endotoxin

≤ 0.01 IU/International Unit of Heparin

≤ 0.03 USP U/International Unit of Heparin

Heavy metal

≤ 30ppm

≤ 30ppm

Sodium

10.5~13.5%(dry substance)

————

Proteins

≤ 0.5%(dry substance)

≤ 0.1%(Weight ratio)

Activity

180 IU/mg(dry substance)

180 USP U/mg(dry substance

Microbial Impurities

TAMC

≤ 1000cfu/g

≤ 1000cfu/g

TYMC

≤ 100cfu/g

≤ 100cfu/g

E.coli

Conforms

Conforms

Staphylococcus aureus

Conforms

Conforms

Salmonella

Conforms

Conforms




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