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        Heparin Sodium
        CAS No.: 9041-08-1 (Anticoagulant)

        Short Description:

        Source: Extracted from pig intestinal mucosa
        Function and use: It is an anticoagulant. It affects many aspects of the coagulation process and can prolong the coagulation time and prothrombin time. This product has rapid anticoagulant effect both in vivo and in vitro. It mainly acts on the formation of fibrin and can also reduce platelet aggregation. For the prevention and treatment of thromboembolic diseases, such as myocardial infarction, pulmonary embolism, cerebrovascular embolism, peripheral venous thrombosis, etc., it can prevent the formation and expansion of thrombus. It can also be used in the early stage of DIC and other anticoagulation in vitro and in vivo. Early application can prevent depletion of fibrinogen and coagulation factors. It can also be used as an anticoagulant in vitro instead of citrate during blood transfusion or during cardiopulmonary bypass.

        Heparin?Sodium-Pharmacopoeia?Standard:?BP/EP


        Product Detail

        Product Tags

        Specification

        Heparin Sodium
        Source Intestinal mucosa of pigs
        Quality standard

        CP

        USP

        EP

        characters

        Appearance

        white or almost white; hygroscopic powder

        /

        white or almost white; hygroscopic powder

        solubility

        freely soluble in water

        /

        freely soluble in water

        specific rotation

        ≥+50°

        /

        /

        identification

        Anti- Xa activity/ anti- IIa : 0.9 – 1.1

        Anti- Xa activity/ anti- IIa : 0.9 – 1.1

        Anti- Xa activity/ anti- IIa : 0.9 – 1.1

        The ratio of peak height of dermal sulfate to peak height of heparin and dermal sulfate in the chromatogram of reference solution (3) shall not be less than 1.3, and the retention time of the main peak of test solution in the chromatogram of test solution shall be consistent with that of control solution (3), and the relative deviation of retention time shall not exceed 5.0% solutions(3)

        The retention time of the major peak of the Sample solution corresponds to that of the Standard solution.

        peak-to-valley ratio: minimum 1.3,the principal peak in the chromatogram obtained with test solution (a) is similar in retention time and shape to the principal peak in the chromatogram obtained with reference solution (c)

        It gives positive reaction of sodium

        A solution of Heparin Sodium imparts an intense yellow color to a nonluminous flame

        It complies with the test for sodium

        /

        1H NMR SPECTRUM: No unidentified signals greater than 4% of the mean of the height of signals 1 and 2 are present in the following ranges: 0.10–2.00,2.10–3.20, and 5.70–8.00 ppm. No signals greater than 200% of the mean of the height of signals 1 and 2 are present in the 3.75–4.55 ppm for porcine heparin.

        NMR spectrometry : No unidentified signals greater than 4% of the mean of the height of signals 1 and 2 are present in the following ranges:0.10-2.00,2.10-3.20,and 5.70-8.00ppm,No signals greater than 200% of the mean of the height of signals and 2 are present in the 3.35-4.55ppm for porcine heparin

        MW

        Mw : 15,000 -19,000Da,M24000 : NMT 20%, and the ratio of M8000-16000 /M16000-24000? ≥1.0

        M24000 : NMT 20%, Mw : 15,000 -19,000Da, and the ratio of M8000-16000 /M16000-24000? ≥1.0

        M24000 : NMT 20%, Mw : 15,000 -19,000Da, and the ratio of M8000-16000 /M16000-24000? ≥1.0

        Nitrogen

        1.5 -2.5 % (on the dried basis)

        1.3 -2.5 % (on the dried basis)

        1.5% -2.5 % (on the dried basis)

        pH

        5.0-8.0

        5.0-7.5

        5.5-8.0

        Appearance of solution

        Clear and colorless;In case of turbidity, according to UV-visible spectrophotometry (general rule 0401), the absorbance is measured at 640 nm wavelength, not more than 0.018;NMT: intensity 1

        /

        The solution is clear (2.2.1) and

        not more intensely coloured than intensity 5 of the range of

        reference solutions of the most appropriate colour (2.2.2,

        Method II).

        Nucleotidic impurities

        A260nm is not greater than 0.10

        NMT 0.1% (w/w)

        A260nm is not greater than 0.15

        Protein

        ≤0.5 %(on the dried basis)

        NMT 0.1% (w/w)

        ≤0.5 %(on the dried basis)

        Related substances

        The peak area of dermal sulfate in the test solution chromatogram should not be greater than that of dermal sulfate in the control solution (5) (2.0%); No other chromatographic peaks except dermal sulfate peaks can be detected

        /

        Sum of dermatan sulfate and chondroitin sulfate:no more than the area of the peak due to dermatan sulfate and chondroitin sulfate in the chromatogram obtained with reference solutions(e)(2.0 per cent);

        Any other impurity:no peak with an area greater than 0.01 times the area of the peak due to dermatan sulfate and chondroitin sulfate in the chromatogram obtained with reference solution (e) is detected.

        Residual solvents

        ≤0.5%

        /

        /

        Loss on drying

        NMT 5.0%

        NMT 5.0%

        NMT 8.0%

        Residue on Ignition

        28.0%-41.0%

        28.0%-41.0%

        /

        Sodium

        10.5%-13.5% (on the dried basis)

        /

        10.5%-13.5% (on the dried basis)

        Heavy metals

        ≤30ppm

        /

        /

        Bacterial endotoxins

        <0.010EU/IU

        <0.03EU/U

        <0.01EU/IU

        Limit of Galactosamine in Total Hexosamine

        /

        NMT 1%

        /

        Absence of Oversulfated Chondroitin Sulfate

        /

        NO features associated with oversulfated chondroitin sulfate are found between 2.12 and 3.00 ppm;?????????????????????? No peaks corresponding to oversulfated chondroitin sulfate should be detected eluting after the heparin peak

        /

        Assay

        ≥180 IU/mg (on the dried basis)

        ≥180 USP U/mg (on the dried basis)

        ≥180 IU/mg (on the dried basis)

        Indications

        1. Prevent venous thromboembolic diseases in general surgery and orthopedic surgery.
        2. In non-surgical procedures, it is used in situations with moderate or high risk of venous thrombosis to prevent venous thromboembolic diseases.
        3. Secondary prevention of venous thromboembolism recurrence in patients with deep vein thrombosis and transient risk factors.
        4. Prevent the formation of blood clots during extracorporeal circulation during hemodialysis.
        5. Treat formed deep vein thrombosis with or without pulmonary embolism.


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