171228-49-2 Posaconazole 4-[4-[4-[4-[[(3R,5R)-5-(2,4-Difluorophenyl)-5-(1,2,4-triazol-1-ylmethyl)oxolan-3-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2-[(2S,3S)-2-hydroxypentan-3-yl]-1,2,4-triazol-3-one
Item |
Specifications |
Result |
Appearance |
White or off-white powder |
White powder |
Specific rotation |
-28°~-34° |
-32° |
Indentification |
IR:Sample spectrum corresponds to that of standard spectrum |
Conform |
HPLC: Retention time of sample comparable with retention time of standard |
Conform |
|
Water |
≤ 2.0% |
1.2% |
Related substances (1) |
PO-R1 ≤0.10% |
ND |
PO-R2 ≤0.10% |
ND |
|
PO-R3 ≤0.10% |
ND |
|
PO-R4 ≤0.10% |
ND |
|
PO-D3&PO-D5 ≤0.10% |
0.08% |
|
PO-D7&PO-D10 ≤0.10% |
ND |
|
Any single unknown impurity ≤0.10% |
0.04% |
|
Total impurities ≤1.0% |
0.1% |
|
Related substances (2) |
PO-E ≤0.10% |
ND |
PO-D1 ≤0.10% |
0.01% |
|
PO-R5 ≤0.10% |
ND |
|
Residual solvents |
Methanol ≤3000ppm |
22ppm |
Enthanol ≤5000ppm |
4744ppm |
|
Dichloromethane ≤600ppm |
115ppm |
|
Ter-Butanol ≤200ppm |
ND |
|
Ter-butyl methyl ether ≤5000ppm |
13ppm |
|
Tetrahydrofuran ≤720ppm |
7ppm |
|
Triethylamine ≤100ppm |
1ppm |
|
Toluene ≤890ppm |
31ppm |
|
N,N-Dimethylformamide ≤880ppm |
2ppm |
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