|
Product Name |
CAS No. |
|
Anidulafungin |
166663-25-8 |
Product Name (品名): | 阿尼芬净 Anidulafungin Remarks: At commercializaiton stage |
| Application(应用) | Used as API or intermediate of Rezafungin |
Molecular Formula (分子式): | C58H73N7O17 |
Molecular Weight (分子量)： | 1140.24 |
Specification | See following COA (Certificate of Analysis) |
| Supplying Capacity (产能) | 200KG/ Year |
Contact Telephone (联系电话): | 023-677770219 |
Contact | Sales Department |
Contact Email: | sales@chemieliva.com |
Structure (结构式):
| |
| CERTIFICATE OF ANALYSIS | ||
| Test Items | Specification | Result |
| Appearance | White or off-white powder | White powder |
| Solubility | Slightly soluble in methanol,practically insoluble in water or acetonitrile | Conforms |
| Identification | HPLC: The retention time of major peak of the sample solution corresponds to that of the standard solution, as obtained in the assay | Conforms |
| IR: Spectrum of Test sample should conform to that of Anidulafungin reference standard | Conforms | |
UV: In the 303nm wavelength place should have maximum absorption | Conforms | |
Methanol solution color and clarity | The solution should be clear, if the solution is opalescent, the opalescent of the solution is not more intense than that of No1 Turbidity standard solution; the solution should be tiny blue, in the wavelength range of 400-760nm absorbance values are less than 0.02 | Conforms |
| Specific optical rotation | -16°to -20° | -18.1° |
Related substance (calculated on anhydrous | Impurity A NMT 0.25% | 0.11 |
| Impurity B NMT 0.15% | 0.06% | |
| Specified unidentified impurity RRT 1.09 NMT 0.30% | 0.03% | |
| Impurity D NMT 0.15% | 0.05% | |
| Impurity E NMT 0.15% | 0.06% | |
| Impurity F NMT 0.15% | 0.06% | |
| Each of unspecified impurity NMT 0.10% | 0.05% | |
| Total impurity NMT 1.0% | 0.63% | |
| Residual Solvents | Methanol NMT 3000PPM | 704PPM |
| Acetone NMT 5000PPM | ND | |
| Acetonitrile NMT 410PPM | ND | |
| Ethy acetate NMT 5000PPM | ND | |
| Tetrahydrofuran NMT 720PPM | ND | |
| DMF NMT 880PPM | ND | |
| Water | NMT 10.0% | 6.7% |
| Residue on ignition | NMT 0.1% | 0.05% |
| Microbial Limit | Total aerobic microbial count NMT 100cfu/g Total combined yeasts and molds count NMT 100cfu/g | ＜10cfu/g ＜10cfu/g |
| Bacterial Endotoxins | ＜1.0EU/mg | ＜1.0EU/mg |
| Assay | 98.0%~102.0% (Calculated on anhydrous basis) | 99.2% |
| 98.0%~102.0% (calculated on anhydrous and solvents-free basis) | 99.2% | |
| Bromopentane | NMT 7.5PPM | 0.2PPM |
| Transportation | Store in tight container at temperatue below -20℃±5℃ and protected from light | |
| Storage | Store in tight container at temperatue below -20℃±5℃ and protected from light | |
