CAS number： 9005-27-0
Molecular formula： C22H44O17
molecular weight： 580.5746
Chemical structure：
Hydroxyethyl starch is often used as volume therapy, which can rapidly increase blood volume after intravenous administration. Hydroxyethyl starch is often used to save shock or bleeding disorders caused by hemorrhage, burns or other traumatic injuries, and can prevent organ failure caused by reduced blood flow and oxygen supply to various organs as a result of circulatory disorders caused by blood volume recovery.
| No. | Item | Specification | Test Result | |||||
| Characters | ||||||||
| 01 | Appearance | White or almost white powder | Almost white powder | |||||
| Identification | ||||||||
| 02 | A: IR | The spectrum obtained shows the same absorption bands as the spectrum obtained with RS | Conforms | |||||
| 03 | C: Molecular weight | Conform | Conforms | |||||
| Tests | ||||||||
| 04 | Appearance of solution | Solution S is not more opalescent than reference suspension II | Conforms | |||||
| 05 | PH | 4.5-7.0 | 5.4 | |||||
| 06 | Absorbance | Maximum 0.025, determined at 400nm | 0.010 | |||||
| 07 | Molecular weight (Mw) and molecular weight distribution Nominal mean Mwl30 000 | |||||||
| -Mw range | 110 500〜149 500 | 121100 | ||||||
| -Mw at 10% lowest fraction | >15 000 | 17435 | ||||||
| -Mw at 10% highest fraction | <390 000 | 295563 | ||||||
| 08 | C2/C6 ratio | nominal value: 9 range: 7.2-10.8 | 8.6 | |||||
| 09 | Molar substitution (MS) | nominal value: 0.4 Range: 0.37〜0.43 | 0.41 | |||||
| 10 | Ethylene glycol | < 40ppm | Conforms | |||||
| 11 | 2-Chloroethanol | <5ppm | None Detected | |||||
| 12 | Ethylene oxide | < 1 ppm | None Detected | |||||
| 13 | Sodium chloride | <0.1% | 0.004% | |||||
| 14 | Heavy metals | < 10 ppm | Conforms | |||||
| 15 | Loss on drying | < 15.0% | 3.5% | |||||
| 16 | Bacterial endotoxins | < 2.5IU/g | Conforms | |||||
| 17 | Microbial contamination | TAMC | <100CFU/g | <10CFU/g | ||||
| TYMC | <10CFU/g | <10CFU/g | ||||||
| Conclusion： Sample of this batch were analyzed according to valid specification, and the result is confirmed. | ||||||||
