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Sichuan Deebio Pharmaceutical Co.,Ltd.

29 YRS

Sichuan, China

CNY 50 Million

83250 m²

100-500 people

Main Products: Pepsin / Kallidinogenase / Elastase / Cytochrome C Solution / Heparin Sodium / Gastric Mucin / Chondroitin Sulfate / Chondroitin Sulfate Sodium

Sichuan, China

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Heparin Sodium / CAS 9041-08-1

OVERVIEW

Packaging

25 KG/Fibre Drum

Lead Time

14-30 days

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DESCRIPTION

Heparin sodium

CAS NO.:9041-08-1	Pharmacopoeia standard：EP / USP
HS CODE :3001.9010.00	File service ：Chinese GMP/ DMF

Source：Porcine intestine mucosa.

Characters：White or almost white powder, highly hygroscopic.

Process：Heparin sodium is extracted from healthy porcine intestine mucosa.

Test Items		Company Specification
Test Items		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-factorIIa ratio:0.9~1.1	Anti-factor Xa to anti-factorIIa 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%（60℃Dry in Vacuum, 3h）	≤ 5.0%（60℃Dry in Vacuum, 3h）
	Residue on ignition	————	28.0%～41.0%
	Bacterial endotoxin	≤ 0.01 IU/International Unit of Heparin	≤ 0.03USPU/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

Typical Properties

Biochemical research, used to prevent prothrombin into thrombin, has the effect of anti blood embolism.

CAS No.

9041-08-1

Formula

(C12H16NS2Na3)20

Molecular Mass

Exact Mass

Matter Classification

organic

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