Customization: | Available |
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Powder: | Yes |
Customized: | Customized |
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Product Name | Heparin Sodium |
Alias | Ardeparin Sodium,Nadroparine Sodium |
CAS | 9041-08-1 |
EINECS | 232-681-7 |
MF | (C12H16NS2Na3)20 |
Grade | Pharmaceutical Grade |
Appearance | White Powder |
TEST ITEMS | SPECIFICATIONS | TEST RESULTS | |
Characters | WHITE 0R WHITE LIKE POEDER | Complies | |
Solubility | Freely soluble in water | Complies | |
Identificatin | A; Delay of cloting of recalcified cimated sheep plasma. B;1H-NMR Spectrum; Comply with the EP speacification of heparin about 1H-NMR requiremenls. C; The principal peak in the chromatogram obtained with test solution is similar in retention time and shape to the principal peak in the chromatogram obtained with reference solution. D; Positive sodium reaction. |
Complies Complies Complies Complies |
|
pH | 5.5~8.0 | 6.6 | |
Realated substances | A:Sum of dermantan sulfate and chondroitin sulfate:≤2.0% B:Any other impurity Free |
Complies Complies |
|
Appearance of solution | A:5%w/v solution is clear and colourlesss B:Solution is not more inicnscly coloured than reference solution BY5 or better |
Complies Complies |
|
Heavy metals | ≤30ppm | Complies | |
Loss on drying | ≤8.0% | 1.4% | |
Protein | ≤0.5% | 0.07% | |
Nitrogen | 1.5%~2.5% | 2.2% | |
Sodium | 9.5%~12.5% | 12.1% | |
Sulphated ash | 28%~41.0% | 37.3% | |
Nueleotide impurlties | 260nm≤0.15 | 260n 0.07 | |
Microbial contamination | A: Total viable acrobic count: max.10 CFU/g B;Fung yeasts: max. 10 CFU/g C; Specified micro orgnisms Escherichina coli Salmonclla Pscudomonas aeruginosa |
10 CFU/g 10 CFU/g Negative Negative Negative |
|
Residual solvents | Ethanol: Not more than 5000 ppm | 955ppm | |
Bacterial endotoxins | 0.01IU/IU of heparin | Complies | |
Impurlfy (NMR) | The N-acetyl protons of heparin show a single peak at 2.04±0.02ppm No peak should be visible at 2.16±0.03ppm |
Complies | |
POTENCY | ≥180 u/mg | 194 u/mg | |
CONCLUSl0N | CONFORH T0 THE REQUIREMENT OF EP7.0 STANDARD |