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        Dalteparin Sodium
        CAS No.: 9041-08-1 (Low molecular weight heparin)

        Short Description:

        Source: Extracted from porcine intestinal mucosa and degraded by sodium nitrite.

        Function and use: Dalteparin sodium is a low molecular weight heparin sodium, which is used for anticoagulation by promoting the inhibitory effect of antithrombin on coagulation factor Xa and thrombin. Dalteparin sodium mainly potentiates the inhibition of coagulation factor Xa, while slightly prolonging the activated partial thromboplastin time (APTT). For the treatment of acute deep vein thrombosis; prevention of coagulation in the extracorporeal circulation system during hemodialysis and hemofiltration in patients with acute renal failure or chronic renal insufficiency; treatment of unstable coronary artery disease such as unstable angina and non-Q Wave myocardial infarction; prevention of surgery-related thrombosis.

        Dalteparin Sodium-Pharmacopoeia Standard: USP/EP

        product-description1


        Product Detail

        Product Tags

        Specification

        Dalteparin Sodium
        Source Intestinal mucosa of pigs
        Quality standard

        USP

        EP

        characters

        Appearance

        /

        white or almost white; hygroscopic powder
        solubility

        /

        freely soluble in water
        identification

        1H NMR SPECTRUM :The ppm values for the methyl group

        of N-acetyl, the H-2 of N-sulfo glucosamine, the H-2 of

        glucuronic acid plus 3-O-sulfo glucosamine, the H-1 of

        iduronic acid, the H-1 of the 2-O-sulfo iduronic acid linked

        to the terminal anhydromannitol and the H-1 of 2-O-sulfo

        iduronic acid, and the H-1 of 3-O-sulfo glucosamine of

        dalteparin in the Sample solution are present at 2.05, 3.28,

        3.39, 5.01, 5.18–5.22, and 5.51, respectively. The ppm

        values of these signals do not differ by more than

        ±0.03 ppm.

        The 13C NMR spectrum obtained is similar to that obtained with the appropriate specific dalteparin sodium CRS

        Mw : 5600 -6400Da, M≤3000 : NMT 13.0%,M≥8000:15.0%-25.0%

        Mw : 5600 -6400Da, M≤3000 : NMT 13.0%,M≥8000:15.0%-25.0%

        Anti-factor Xa activity/ anti- factor IIa : 1.9-3.2

        Anti- factor Xa activity/ anti- factor IIa : 1.9-3.2

        It complies with the test for sodium

        It complies with the test for sodium
        Appearance of solution /

        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).

        pH

        5.5-8.0

        5.5-8.0

        Molar ratio of Sulfate carboxylate ≥1.8 ≥ 1.8
        Nitrogen

        1.5 %-2.5 % (on the dried basis)

        1.5 %-2.5 % (on the dried basis)

        Sodium 10.5% -13.5% (on the dried basis)

        10.5% -13.5% (on the dried basis)

        Nitrite

        ≤ 5ppm

        ≤ 5ppm

        Loss on drying

        ≤10.0%

        ≤5.0%

        Bacterial endotoxins

        <0.01EU/U

        <0.01EU/IU

        Boron

        ≤1ppm

        ≤ 1ppm

        Assay Anti- factor Xa activity

        110-210 IU/mg (on the dried basis)

        110-210 IU/mg (on the dried basis)

        Anti- factor IIa activity

        35-100 IU/mg (on the dried basis)

        35-100 IU/mg (on the dried basis)

        Indications

        Treat acute deep vein thrombosis.
        Prevent coagulation in the extracorporeal circulation system during hemodialysis and blood filtration in patients with acute renal failure or chronic renal insufficiency.
        Treat unstable coronary artery diseases, such as unstable angina and non Q-wave myocardial infarction.
        Prevent thrombosis related to surgery.


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