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: BP/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 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 and the H-1 of the 2-O-sulfo
iduronic acid linked to the terminal anhydromannitol, 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±0.03ppm
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- Xa activity/ anti- IIa : 1.9-3.2 Anti- Xa activity/ anti- IIa : 1.9-3.2
Meets the requirements for Sodium Content It complies with the test for sodium
Appearance of solution / clear;NMT: intensity 5
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- Xa activity 110-210 IU/mg (on the dried basis) 110-210 IU/mg (on the dried basis)
Anti- IIa activity 35-100 IU/mg (on the dried basis) 35-100 IU/mg (on the dried basis)

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