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
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) | ||
CAS No.: 9041-08-1 (Anticoagulant)
CAS No.: 679809-58-6 (Low molecular weight heparin)
