| Customization: | Available |
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| Powder: | Yes |
| Customized: | Customized |
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Micafungin sodium (trade name: Mikaimin) is the second echinocandins to be used clinically after caspofungin. It is an antifungal drug developed by Astellas Japan and first marketed in Japan in 2002 and approved by the FDA in the US in May 2005 for the indications of fungemia caused by Aspergillus and Candida, respiratory tract fungal disease C, and gastrointestinal fungal disease. It is also used clinically in combination with amphotericin and triazole antifungal drugs. Current reports on the purified desalting and concentration of sodium micafungin are mainly carried out using ion exchange chromatography columns. Ion exchange chromatography is a time-consuming and labor-intensive purification process, and given the heat-sensitive nature of micafungin sodium, there is an urgent need for a preparation method with more simplified steps, greater efficiency, economy and ease of industrial scale-up.
| Analysi | Specifications | Result |
| Assay | ≥99% | 99.2% |
| Appearance | White powder | Complies |
| Loss on Drying | ≤1.0% | 0.04% |
| Ash | ≤1.0% | 0.1% |
| As | ≤2.0ppm | <2.0ppm |
| Pb | ≤2.0ppm | <2.0ppm |
| Insoluble impurity content | ≤0.05% | Complies |
| Total Plate Count | ≤1000 cfu/g | Complies |
| Yeast &. Mold | ≤100 cfu/g | Complies |
| E.Coli | Negative | Negative |
| Salmonella | Negative | Negative |
| Conclusion |
Conform USP Standard.
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| Storage condition |
Store in cool & dry place, Keep away from strong light and heat.
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| Shelf life |
2 years when properly stored.
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