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 |
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 this product 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 detected 0.01% Not detected Not detected 0.02% 0.07% |
Enantiomeric and diastereoisomer | 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 detected Not detected Not detected Not detected 0.02% 0.04% |
Residual solvents | Methanol: ≤3000 ppm Dichloromethane: ≤600 ppm Acetone: ≤5000 ppm Ethanol: ≤5000 ppm Dimethyl sulfoxide: ≤5000 ppm | 31 ppm 53 ppm Not detected Not detected Not 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/g Total molds and Yeast Count (TYMC): ≤101cfu/g Escherichia Coli: Absence | 10 cfu/g < 10 cfu/g Not detected |
Assay | C37H42F2N8O4： 98.0% 〜102.0% (on the anhydrous basis) | 101.0% |
Conclusion | Conform to Enterprise Standard
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Function of Posaconazole
Posaconazole is a triazole antifungal drug, which can inhibit the synthesis of fungal cell membranes, thereby producing antifungal effects. It can mainly be used to prevent invasive Aspergillus and Candida infections, and is suitable for the prevention of acute Aspergillus and Candida infections caused by severe immunodeficiency in patients 13 years of age and older.
After the above patients received hematopoietic stem cell transplantation, patients with graft-versus-host disease, or patients with hematological malignancies with prolonged neutropenia caused by chemotherapy, so this drug is mainly used to prevent invasive Aspergillus and Candida Infection.
