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 used to treat and prevent serious fungal infections. It belongs to a class of drugs called echinocandins.
How it Works:
It operates by a targeted mechanism, inhibiting the synthesis of β-(1,3)-D-glucan, a critical polysaccharide essential for building the fungal cell wall. Without this structural component, the fungal cell wall becomes weakened and unstable, leading to cell rupture and death. This mode of action is highly specific to fungi, giving it a favorable safety profile.
Primary Uses:
Micafungin is administered intravenously (IV) in a hospital or clinical setting for:
Treatment of Candidemia: Fungal bloodstream infections.
Treatment of Acute Disseminated Candidiasis: When the infection spreads through the body.
Treatment of Esophageal Candidiasis: A severe fungal infection of the esophagus.
Prophylaxis: To prevent fungal infections (particularly from Candida) in patients undergoing hematopoietic stem cell transplantation (HSCT).
It is often a first-line treatment for invasive candidiasis and is effective against a broad spectrum of Candida species, including some strains resistant to other antifungals like fluconazole.
Administration and Important Considerations:
Route: Strictly intravenous (IV) infusion, given slowly over one hour.
Side Effects: Common side effects include diarrhea, nausea, vomiting, headache, and swelling. More serious side effects can involve liver function test abnormalities, rare cases of significant liver damage, and infusion-related reactions (like rash, itching, or swelling).
Key Precautions:
It may cause hepatotoxicity (liver injury), requiring monitoring of liver enzymes.
It can cause hemolysis (breakdown of red blood cells) and a rare condition called hemoglobinuria.
Allergic reactions, including anaphylaxis, are possible.
Its use in pregnant women should be limited to cases where the benefit outweighs the potential risk.
Summary Table
| Property | Description |
|---|
| Drug Name | Micafungin Sodium |
| Brand Name | Mycamine® |
| Drug Class | Echinocandin Antifungal |
| Mechanism of Action | Inhibits synthesis of β-(1,3)-D-glucan in the fungal cell wall |
| Common Uses | Invasive Candidiasis, Esophageal Candidiasis, Prophylaxis in HSCT patients |
| Administration | Intravenous (IV) infusion only |
| Key Monitoring | Liver function tests (LFTs) |
Disclaimer: This information is for educational purposes only. Micafungin is a potent medication that requires careful medical supervision. Its use must be managed by a healthcare professional.
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