| Customization: | Available |
|---|---|
| CAS No.: | 9041-08-1 |
| Formula: | (C12h16ns2na3)20 |
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| Items | Requirements | Result |
| Appearance | Appearance: white or almost white, hygroscopic powder. Solubility: freely soluble in water. | Conforms |
| Identification |
It complies with the requirements described under assay. | Conforms |
| The ratio of anti-factor Xa to anti-factor IIa activity determined as described under assay, ranges between 0.9 and 1.1. | 1.0 | |
| NMR spectrometry the large heparin sodium signals must be present: 2.04 ppm, 3.27 ppm(doublet), 4.34 ppm, 5.22 ppm and 5.42 ppm, all witin ±0.03 ppm; dermatan sulfate with methyl signal at 2.08 ±0.02 ppm may be observed; no unidentified signals larger than 4% compared to the height of the heparin signal at 5.42 ppm are present in the ranges 0.10~2.00 ppm, 2.10~3.10 ppm and 5.70~8.00ppm; | Conforms | |
| Liquid chromatography 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. | Conforms | |
| It complies with the test for sodium. | Conforms | |
| Appearance of solution | The solution is clear and not more intensely coloured than intensity 5 of the range of reference solutions of the most appropriate colour. | Conforms |
| PH | 5.5~8.0 | 6.5 |
| Nucleotidic impurities | 260nm≤0.15 | 0.05 |
| Protein impurities | NMT 0.5% (dried substance) | 0.015% |
| Related substances | Sum of dermatan sulfate and chondroitin sulfate: not more than the area of the peak due to dermatan sulfate and chondroitin sulfate in the chromatogram obtained with reference solution(2.0%); any other impurity: no peak with an area greater than 0.01 times the area of the peak due to dermatan sulfate and chondroitin sulfate in the chromatogram obtained with reference solution is detected. | Conforms |
| Nitrogen | 1.5%~2.5%(dried substance) | 2.0% |
| Sodium | 10.5%~3.5%(dried substance) | 11.6% |
| Loss on Drying | NMT 8.0% | 2.3% |
| Sulphated Ash | 28.0%~41.0% | 35.2% |
| Bacterial endotoxins | NMT 0.01IU per international unit of heparin | Conforms |
| Residual Solvents | Methano l: Not more than 3000ppm | 5ppm |
| Ethanol: Not more than 5000ppm | 3826ppm | |
| Acetate: Not more than 5000ppm | 1ppm | |
| Microbiological | Total Bacterial count≤1000CFU/g | Conforms |
| Yeasts and moulds≤100 CFU/g | Conforms | |
| Assay | Anti-factor IIa NLT 180IU/mg(dried substance) | 215.2IU/mg |
| Conclusion | The product complies with EP9 and internal specifications. | |
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