China Heparin Sodium of Deebio for Treating Thromboembolic Disease Prevention factory and manufacturers

Heparin Sodium of Deebio for Treating Thromboembolic Disease Prevention

CAS NO.: 9041-08-1

HS CODE: 3001.9010.00

File Service: Chinese-GMP、DMF

Pharmacopoeia standard: EP/USP

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Product Detail

Product Tags

Detail

1. Characters: White or almost white powder, highly hygroscopic.

2. Source: Porcine intestine mucosa.

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

4. Indications and uses: This product is mainly used for thromboembolic disease prevention, especially suitable for the need of anticoagulant quickly, such as: 1. Acute or chronic venous thrombosis or no significant blood flow dynamic change of pulmonary embolism(PE).Heparin can stop embolus extension to make time for spontaneous thrombolysis of body. 2. Prevention and treatment of Atrial fibrillation with embolism. 3. Treatment of early diffuse intravascular coagulation(DIC). 4. Prevention and treatment of peripheral arterial thrombosis or myocardial infarction. 5. Other in vitro anticoagulation: such as cardiovascular surgery, in vitro circulation, hemodialysis, angiography, also can be used for transfusion or blood specimen preparation, at present the main indications of heparin application are deep vein thrombosis(DVT), PE and thrombosis in high risk patients.

Why us？

·Passed the Chinese GMP

·27 years of biological enzyme R&D history

·Raw materials are traceable

·Comply with USP、EP and customer standard

·Export to over 30 countries and regions

·Has the ability of quality system management such as US FDA, Japan PMDA, South Korea MFDS, etc.

Specification

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-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%（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	≤ 0.03 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