Description
Product Description:
Heparin Sodium (Heparin Sodium) is Heparin Sodium sulfate glycosaminoglycan anticoagulants.Heparin is from pigs or cows in the intestinal mucosa of extraction of amino dextran sulfate sodium salt, mucopolysaccharide material.In recent years, studies have shown that heparin and fall hematic fat action.
This product is white or kind of white powder, have led to wet.This product is soluble in water. Take this product than the curl, precision said, adding water to dissolve and diluted into each 1ml contains 2.5mg of solution, agarose gel electrophoresis test, the test and the ratio of the standard show spots by the migration distance is 0.9-1.1.
Function:
1.The treatment of various diseases concurrent disseminated intravascular coagulation early.
2.Prevention of arterial and venous thrombosis and pulmonary embolism.
3.Treatment of arterial and venous thrombosis and pulmonary embolism, ischemic stroke, unstable angina (to alleviate the symptoms, prevention of myocardial infarction), acute myocardial infarction (prevention of early reinfarction and infarct extension, reduce mortality).
4.The artificial lung, peritoneal dialysis or hemodialysis as anticoagulants.
5.thrombolytic therapy as maintenance therapy.
Heparin Sodium (Heparin Sodium) is Heparin Sodium sulfate glycosaminoglycan anticoagulants.Heparin is from pigs or cows in the intestinal mucosa of extraction of amino dextran sulfate sodium salt, mucopolysaccharide material.In recent years, studies have shown that heparin and fall hematic fat action.
This product is white or kind of white powder, have led to wet.This product is soluble in water. Take this product than the curl, precision said, adding water to dissolve and diluted into each 1ml contains 2.5mg of solution, agarose gel electrophoresis test, the test and the ratio of the standard show spots by the migration distance is 0.9-1.1.
Function:
1.The treatment of various diseases concurrent disseminated intravascular coagulation early.
2.Prevention of arterial and venous thrombosis and pulmonary embolism.
3.Treatment of arterial and venous thrombosis and pulmonary embolism, ischemic stroke, unstable angina (to alleviate the symptoms, prevention of myocardial infarction), acute myocardial infarction (prevention of early reinfarction and infarct extension, reduce mortality).
4.The artificial lung, peritoneal dialysis or hemodialysis as anticoagulants.
5.thrombolytic therapy as maintenance therapy.
6.used for the prevention of blood coagulation and blood bank transfusion of blood and other body save anticoagulants.
| Product Name | Heparin Sodium | |
| Specifications | API | |
| Origin | Porcine intestinal mucosa | |
| Acceptance Criteria | EP 10.0 | |
| Code | 1610010001 | |
| Batch size | 61.3765kg | |
| Sampling quantity | 27.0g | |
| Inspection Items | Specifications | Test Result |
| Character | ||
| Exterior | white or almost white, hygroscopic powder, freely soluble in water | Complies |
| Identification | ||
| Sodium | Conforms | Complies |
| Liquid Chromatography | Conforms | Complies |
| Anti FXa/Anti Flla | 0.9 〜1.1 | 1.0 |
| Test | ||
| Clarity and Color of Solution | Conforms | Complies |
| PH | 5.5 〜8.0 | 7.0 |
| Nucleotidic impurity | A260nm<0.15 | 0.048 |
| Protein | ＜=0,5%(dried substance) | 0.09% |
| Related Substances | DS+CS≤2.0% | 0.06% |
| Other chromatographic peaks should not be defected | Absent | |
| Nuclear magnetic resonance spectrometry |
The large heparin sodium signals must be present:2.04ppm, 3.27ppm(doublet),4.34ppm,5.22ppm and 5.42ppm,all with ±0.03ppm;the ¹H-NMR spectrum obtained with the test sample and that obtained with heparin sodium for NMR identification CRS are compared quaiitatively after the 2 spectra have been normalised so as to have a similar intensity;dermatan sulfate with a methyl signal at 2.08±0.02ppm may be observed;No unidentified signals larger than 4 percent compared to the height of the heparin at 5.42ppm are present in the ranges: 0.10-200ppm, 2.10-3.10ppm and 5.70-8.00ppm; Signals from the solvent or process -related substances may be present and have to be identified to be accepted pvariations in the intensity of some signal regions of the spectrum of heparin may occur:the intensity-vanable regions are between 3.35ppm and 4.55ppm, where the signal pattern is approximately kept but intensity varies. |
Complies |
| Nitrogen | 1.5%〜2.5%(dried substance) | 1.9% |
| Sodium | 10.5%-13.5%(dried substance) | 12.6% |
| Loss on Drying | ≤8.0% | 2.0% |
| Residual Solvents | Methanol≤0.3% | Absent |
| Ethanol≤0.5% | 0.048% | |
| Acetone≤0.5% | Absent | |
| Content-Anti Factor II a | ≥180 IU/mg(dried substance) |
226 lU/mg (dried) 221 lU/mg (wet) |
| Micro Organisms | ||
| Bacterial Endotoxins | <0.010EU/IU | <0.010EU/IU |
| Aerobic Bacteria Count | <103cfu/g | <10cfu/g |
| Fungi/Yeast | <102cfu/g | <10cfu/g |
| Conclusion | This product has been tested in accordance with the EP10.0 | |
