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High Performance China Heparin Sodium


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

    Product Tags

    We attempt for excellence, company the customers”, hopes to become the best cooperation team and dominator business for staff, suppliers and customers, realizes worth share and continual advertising for High Performance China Heparin Sodium, We just not only deliver the superior quality to our clients, but additional even important is our greatest services plus the competitive selling price.
    We attempt for excellence, company the customers”, hopes to become the best cooperation team and dominator business for staff, suppliers and customers, realizes worth share and continual advertising for China Heparin Sodium, Customer’s satisfaction is always our quest, creating value for customers is always our duty, a long term mutual-beneficial business relationship is what we’re doing for. We’ve been an absolutely reliable partner in your case in China. Of course, other services, like consulting, can be offered too.

    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.

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    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

    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

    We attempt for excellence, company the customers”, hopes to become the best cooperation team and dominator business for staff, suppliers and customers, realizes worth share and continual advertising for High Performance China Heparin Sodium We just not only deliver the superior quality to our clients, but additional even important is our greatest services plus the competitive selling price.
    High Performance China Heparin, Customer’s satisfaction is always our quest, creating value for customers is always our duty, a long term mutual-beneficial business relationship is what we’re doing for. We’ve been an absolutely reliable partner in your case in China. Of course, other services, like consulting, can be offered too.


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