High Purity Posaconazole CAS:171228-49-2 GMP Certified for Antifungal Drug Formulations
Property Description
Chemical Name (IUPAC):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
Molecular Formula C<sub>37</sub>H<sub>42</sub>F<sub>2</sub>N<sub>8</sub>O<sub>4</sub>
Molecular Weight:700.78 g/mol
CAS Number:171228-49-2
Appearance:White to off-white crystalline powder
Solubility Practically insoluble in water; soluble in DMSO, ethanol, and methanol
Melting Point:~170–174°C (decomposes)
Partition Coefficient (LogP):~5.3 (highly lipophilic)
pKa:~3.6 (weak base)
StorageConditions 2–8°C (refrigerated), protect from light and moisture
Stability:Stable under recommended storage; hygroscopic
Certificate of Analysis (COA) – Posaconazole
| Parameter | Specification | Test Method | Result |
|---|
| Product Name | Posaconazole | — | Complies |
| CAS No. | 171228-49-2 | — | Complies |
| Molecular Formula | C₃₇H₄₂F₂N₈O₄ | — | Complies |
| Appearance | White to off-white crystalline powder | Visual inspection | Complies |
| Identification | Matches reference standard | HPLC/FTIR | Complies |
| Assay (HPLC Purity) | ≥98.5% | USP <621>/EP 2.2.29 | 99.3% |
| Water Content | ≤0.5% | Karl Fischer | 0.2% |
| Residue on Ignition | ≤0.1% | USP <281> | 0.05% |
| Heavy Metals (as Pb) | ≤10 ppm | ICP-MS/USP <232> | <5 ppm |
| Related Substances | Total impurities ≤1.0% | HPLC | 0.7% |
| Single Unknown Impurity | ≤0.5% | HPLC | 0.3% |
| Sulfated Ash | ≤0.1% | USP <281> | 0.06% |
| Microbial Limits | Meets USP <61> requirements | Microbial enumeration | Complies |
| Particle Size | 90% ≤50μm (if micronized) | Laser diffraction | 45μm |
| Storage Conditions | 2-8°C, protected from light/moisture | — | — |