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Heparin sodium
| ITEMS | LIMIT |
| Item | Topical heparin sodium ( USP24, EPIII, CP2000) |
| Origin | Porcine or bovine intestinal mucosa |
| Appearance | White powder |
| Specific optical rotation | ≥+35 |
| Electrophoresis | Meet requirement |
| Sodium salt identification reaction | Meet requirement |
| ¡¡PH number | 5.0-7.5 |
| Solubility (40%) | Meet requirement |
| Aqueous solution appearance | Colorless or thinner than standard solution¡¡ |
| Protein | Meet requirement¡¡ |
| Loss on drying | ≤5.0% |
| Heavy metal (m/m) ppm | ≤30 |
| Nitrogen (m/m) | ≤1.3-2.5% |
| Sulfur content (m/m) | ≥10% |
| Endo toxins (EU/USP.U) | ≤0.03 |
| Anti-factor X..activity | Meet requirement |
| Bacteria microorganism | Total viable aerobic≤100 |
| Detection (CFU/g) | Microorganism Meet requirement Microorganism |
| Assay (USP.U/mg) | ≥150 |
| ¡¡Sulfated ash (m/m) | 30.0%-41.0% |
| Sodium content (m/m) | 9.5-12.5% |
| Solvent(m/m)Pam | |
| Dermaptan sulfate (m/m) | |
| Potassium salt (m/m) | Meet requirement |
| Viscosity25°±1Pa.s | ¡≤0.030 |
| Size | |
| Absorbance | 260nm≤0.20 |
| (0.4%)260nm | 280nm≤0.15 |
| 280nm | 400nm≤0.035 |
| (5.0%)400nm, 420nm | 420nm≤0.030 |
| 470nm | 470nm≤0.020 |
| Pyrogen | Meet requirement |
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