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

USP

EP

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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

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).

5.5-8.0

5.5-8.0

1.5 %-2.5 % (on the dried basis)

1.5 %-2.5 % (on the dried basis)

10.5% -13.5% (on the dried basis)

≤ 5ppm

≤ 5ppm

≤10.0%

≤5.0%

＜0.01EU/U

＜0.01EU/IU

≤1ppm

≤ 1ppm

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

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

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

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