Heparin Sodium of for Treating Thromboembolic Disease Prevention

Introduction

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

Product Details

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 USPEP 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

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

1.52.5%dry substance

1.32.5%dry substance

Nucleotidic impurities

A260 ≤ 0.15(4mg/ml)

≤ 0.1w/w

Related substances

Conforms

————

Limit ofgalactosamine in total hexosamine

————

≤ 1.0%

Oversulfated chondroitin sulfate

————

Conforms

pH

5.58.01%

5.57.51%

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

10.513.5%dry substance

————

Proteins

≤ 0.5%dry substance

≤ 0.1%Weight ratio

Activity

≥ 180 IU/mgdry substance

≥ 180 USP U/mgdry 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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