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Micafungin sodium is a water-soluble, semi-synthetic echinocandin lipopeptide that is a dose-dependent non-competitive inhibitor of 1,3-β-D glucan synthetase. Dextran is a fibrous polysaccharide wound with 3 spiral-shaped glucose aggregates, which are necessary structures of the fungal cell wall and also play an important role in fungal growth and differentiation.
Micafungin sodium is used to treat fungal septicemia, mycosis of the respiratory tract, and mycosis of the gastrointestinal tract caused by aspergillus and candida.
| Items | Specifications | Results |
| Appearance | Light yellow to off-white powder | Conforms |
| Assay | ≥98.0% | 99.45% |
ITEMS | SPECIFICATIONS | RESULTS |
Appearance | White crystall powder | Conform |
Specific rotation | 〔α〕 2 5D =-20°～ -30° C=1.0 in water | -22.6° |
Identification | IR: Sample spectrum corresponds to that of standard spectrum. | Conform |
HPLC: Retention time of sample comparable with retention time of standard. | Conform | |
Sodium (AAS) | Conform | |
PH | 5.5- 7.0 | 6.5 |
Related substance | MF-R1 NMT 0.5% | 0.21% |
MF-R3 NMT 0.15% | 0.03% | |
MF-R4 NMT 0.15% | 0.01% | |
MF-R5 NMT0.15% | ND | |
MF-R6 NMT 0.6% | 0.10% | |
Single largest unknown impurity NMT 0.1% | 0.03% | |
Total impurities NMT 1.0% | 0.5% | |
Ethyl acetate NMT 5000ppm | 14ppm | |
Ethanol NMT 5000ppm | 39ppm | |
Methanol NMT 3000ppm | 69ppm | |
N,N-Dimethylformamide NMT 880ppm | ND | |
N,N-Diisopropylethylamine NMT 1000ppm | 17ppm | |
Acetonitrile NMT 410ppm | 18ppm | |
Isopropanol NMT 5000ppm | ND | |
Water | NMT 8.0% | 3.2% |
Bacterial Endotoxins | NMT0.5Eu/mg | 0.07Eu/mg |
Heavy metal | NMT 10ppm | Conforms |
Assay | 97.0%～102.0% (on anhydrous basis) | 99.45% |
Conclusion | QUALIFIED. | |
Micafungin sodium is a prescription antifungal medication. It belongs to the echinocandin class of drugs.
It works by inhibiting the synthesis of a key component (β-(1,3)-D-glucan) of the fungal cell wall, causing the fungal cells to rupture and die.
It is used intravenously (IV) to treat and prevent serious fungal infections, including:
Candidemia (bloodstream infections)
Esophageal Candidiasis
Prophylaxis (prevention) in patients undergoing stem cell transplants.
Common side effects can include liver enzyme changes, nausea, and headache. It is typically administered in a hospital setting.
An echinocandin antifungal drug, represent a valuable treatment option for fungal infections.
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