| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Customized |
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| Product Name: | Heparin Sodium | Batch No.: | HHD220401 |
| Manufacture Date: | 2021-05-03 | Quantity: | 6236.88mega |
| Report Date: | 2021-05-15 | Specification | Injectable Grade |
| Expire Date: | 2023-05-02 | 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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