CAS number: 9004-54-0
Molecular formula:
molecular weight:
Chemical structure:
Items | Specifications | Results | |||||
Appearance | White or off white powder | white power | |||||
Solubility | Freely soluble in water, insoluble in ethanol | Complies | |||||
Identification | The infrared absorption spectrum should be consistent with that of the reference. | Complies | |||||
Specific rotation | +195º~+200º | +196º | |||||
The average molecular mass of the 10percent high fraction is not greater than 185000. | 172951 | ||||||
The average molecular mass of the 10percent low fraction is not less than 15000. | 21216 | ||||||
The average molecular mass(Mw):64000~76000 | 69004 | ||||||
Test | Appearance of solution | Should be clear and colorless | Complies | ||||
Acidity or alkalinity | Red or orange | Complies | |||||
Residual solvent | Ethanol: Should be not more than 0.5% | Complies | |||||
Mathanol: Should be not more than 0.05% | Complies | ||||||
Propanol: Should be not more than 0.5% | Complies | ||||||
Nitrogen | Should be not more than 0.007%. | Complies | |||||
Loss on drying | ≤5.0% | 4.60% | |||||
Residual on ignition | ≤0.3% | 0.03% | |||||
Bacterial endotoxin | < 8EU/g | Complies | |||||
The limit of microbial | Total aerobic microbial count(TAMC):≤102CFU/g | ﹤10 cfu/g | |||||
Total yeast and mould count(TYMC):≤101CFU/g | ﹤10 cfu/g | ||||||
Escherichia coli: Should not exist | Absent/g | ||||||
Storage | Seal and store in a dry place. | ||||||
Conclusion: It complies with European Pharmacopoeia 9.0 |