Appearance | White or off-white powder | White powder |
Solubility | Freely soluble in water | Conforms |
Specific optical rotation[a]20D | -15.0°to -10.0°(anhydrous and sodium ion-free substance,C=10mg/ml,H2O | Conforms |
pH | 7.0~9.0 | 8.0 |
Water content | 8.0%max | 4.6% |
Purity(HPLC) | 95.0%min | 99.6% |
Related substance(HPLC) | The largest individual impurity test 3.0%max The total impurities test 5.0%max | 0.15% 0.4% |
Residual solvent | DCM:6000ppm max | N.D |
ACN:410ppm max | 13ppm | |
MetOH:3000ppm max | N.D | |
DMF:880ppm max | N.D | |
Isopropyl ether:5000ppm max | N.D | |
Isopropanl:5000ppm max | N.D | |
Acid group ions | TFA:0.1%max | N.D |
PO43+: 0.1%max | N.D | |
Cl-:0.1%max | N.D | |
HAC:0.1%max | N.D | |
Microbiological tests | Total microbacterial count:1000cfu/g max | Conforms |
Yeast and Mould:100cfu/g max | Conforms | |
Escherichia coil presence:negative | Conforms | |
P.Aeruginosa:negative | Conforms | |
S.Aureus:negative | Conforms | |
Total heavy metals | 10ppm max | Conforms |
Sodium ion | 5.0%max | 2.3% |
High molecular protein | 0.5%max | 0.03% |
| 80.0%min | 92.5% |
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