| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Non-Customized |
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| Product Name: | Heparin Sodium |
| Other Name | heparin sodium |
| CAS: | 9041-8-1 |
| EINECS: | 238-884-7 |
| MF: | ca. (C12H16NS2Na3)20 |
| MW: | 288.428 |
| Title: | Factory Provide Heparin Sodium,lithium heparin tube,bovine heparin |
| Shelf Life | 2 years |
| Appearance | White to off-white powder |
| Brand Name: | HHD Pharm |
| Form | Powder |
| Place of Origin: | Wuhan, China (Mainland) |
| Packaging: | Bottle, Can, Drum, Plastic Contain |
| Standard: | USP EP JP etc. |
| Introduction: | 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. |
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.
| Product Name: | Heparin Sodium | Batch No.: | NOV220401 |
| Manufacture Date: | 2022-05-03 | Quantity: | 6236.88mega |
| Report Date: | 2022-05-15 | Specification | Injectable Grade |
| Expire Date: | 2024-05-02 | Origin | Bovine Intestinal Mucosa |
| Items | Requirements | Result | |
| Appearance | White or almost white hygroscopic powder | Complies | |
| Solubility | Freely soluble in water | Complies | |
| Identification A | It delays the clothing of recalcified citrated sheep plasma. | Complies | |
| Identification B | 1H-NMR | Complies | |
| Identification C | In the chromatogram of related substance, the principal peak obtained with test solution is similar in retention time and shape to the principal peak in the chromatogram obtained with reference solution. | Complies | |
| Identification D | It complies with the test for sodium | Complies | |
| Appearance of solution | A: The solution is clear. | Complies | |
| B: The solution is not more intensely coloured than reference solution Y5. | Complies | ||
| PH | 5.5~8.0 | 7.3 | |
| Nucleotidic impurities | Absorbance at 260 nm: ≤0.15 | 0.041 | |
| Protein | ≤0.5%(Dried substance) | 0.06% | |
| Related substances | Dermatan Sulfate+Chondroitin Sulfate: not more than the area of the peak due to dermatan sulfate and chondroitin sulfate in the chromatogram obtained with reference solution (e)(2.0%) |
<0.1% | |
| Any other impurity: No peaks other than the peak due to dermatan sulfate+chondroitin sulfate are detected |
Negative | ||
| Nitrogen | 1.5%~2.5%(Dried substance) | 2.1% | |
| Sodium | 10.5%~13.5%(Dried substance) | 11.9% | |
| Heavy metals | ≤30ppm | Complies | |
| Loss on drying | ≤8.0% | 1.0% | |
| Becterial endotoxins | <0.01 IU/IU | Complies | |
| Protency | -- | 156 IU/mg | |
| Potency(dried substance) | ≥150 IU/mg(Dried substance) | 158 IU/mg | |
| Specific rotation | ≥+50° | +55° | |
| Molecular weight determinations | Mw: 15,000~19,000Da; M24000≤20%; M8000~16000/M16000~24000≥1.0 |
15100 11% 2.3 |
|
| Residual solvents | Ethanol≤4500ppm | 1298ppm | |
| Microbial contamination | A: TAMC≤10 CFU/g TYMC≤10 CFU/g B: Specified micro organisms Escherichia coli: negative Salmonella: negative Pseudomonas aeruginosa: negative |
<10 CFU/g <10 CFU/g Negative Negative negative |
|
| Conclusion | Comply with the EP & In-house specification. | ||
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