Product Information |
Product name |
Posaconazole |
CAS No. |
171228-49-2 |
Molecular Formula |
C37H42F2N8O4 |
Molecular Weight |
700.78 |
Quality Standard |
98% up by HPLC, DMF |
Appearance |
White to off-white powder |
COA of Posaconazole |
ITEMS |
SPECIFICATION |
RESULT |
Appearance |
White to off-white powder |
Conforms |
Melting point |
167 〜171°C |
167.5 〜168.0°C |
Specific optical rotation |
-28.5°〜-24.5°The retention time of the major peak of the test |
-27.2° |
Identity |
The retention time of the major peak of the test solution corresponds to that of the standard solution, as obtained in the Assay. |
Conforms |
The infrared absorption spectrum of thisproduct should corresponds to the reference spectrum. |
Conforms |
|
Crystallinity |
There are characteristic peaks at 7.7°±0.2°,9.9°±0.2°, 17.8°±0.2°, 19.5°±0.2°, 20.0°± 0.2°(Crystal form 1). |
Conforms |
Water content (%w/w) |
≤0.5% |
0.1% |
Residue on ignition |
≤0.1% |
0.02% |
Related substances |
QR0005DS-IN-01: ≤0.10%QR0005DS-IN-02: ≤0.10%QR0005DS-IM-08: ≤0.10%QR0005DS-IM-06: ≤0.10%Other maximum unknown impurity ≤0.10%Total impurities: ≤0.40% |
Not detected0.01%Not detectedNot detected0.02%0.07% |
Enantiomeric anddiastereoisomer |
QR0005DS-IM-02: ≤0.10%QR0005DS-IM-03: ≤0.10%QR0005DS-IM-04: ≤0.10%QR0005DS-IM-01+QR0005DS-IM-05+ QR0005DS-IM-06: ≤0.10%QR0005DS-IM-07 ≤0.10%Total isomer impurities: ≤0.50% |
0.01%Not detectedNot detectedNot detectedNot detected0.02%0.04% |
Residual solvents |
Methanol: ≤3000 ppmDichloromethane: ≤600 ppmAcetone: ≤5000 ppmEthanol: ≤5000 ppmDimethyl sulfoxide: ≤5000 ppm |
31 ppm53 ppmNot detectedNot detectedNot detected |
Benzene |
≤2 ppm |
Not detected |
Heavy metals |
≤10 ppm |
Conforms |
Bacterial endotoxin |
≤0.25 EU/mg |
Conforms |
Microbial limit |
Total Aerobic Microbial Count (TAMC): ≤102 cfu/gTotal molds and Yeast Count (TYMC): ≤101cfu/gEscherichia Coli: Absence |
10 cfu/g< 10 cfu/gNot detected |
Assay |
C37H42F2N8O4： 98.0% 〜102.0% (on the anhydrous basis) |
101.0% |
Conclusion |
Conform to Enterprise Standard |
|
Usage |
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