Caspofungin (INN) (brand name Cancidas worldwide) is a lipopeptide antifungal drug from Merck & Co., Inc. discovered by James Balkovec, Regina Black and Frances A. Bouffard. It is a member of a new class of antifungals termed the echinocandins. It works by inhibiting the enzyme (1→3)-β-D-glucan synthase and thereby disturbing the integrity of the fungal cell wall. Caspofungin was the first inhibitor of fungal (1→3)-β-D-glucan synthesis to be approved by the United States Food and Drug Administration. Caspofungin is administered intravenously.
Specification
| Item | Specifications | Result |
| Appearance | White or almost white powder | Off white powder |
Indentification
|
HPLC:The retention time of principle peak obtained from
Test solution should conform with that obtained from
Standard solution, as test in Assay
| Conforms |
IR: Spectrum of Test sample should conform to that
of Caspofungin Acetate Reference Standard
| Conforms | |
| Specific Optical Rotation | -102.0°~108.0 ° | -105.3° |
| PH | 5.0~7.0 | 6.5 |
| Water | 10.0% | 7.5% |
| Solution color and clarity | Solution should be clear colorless | Conforms |
| Related substances I | Impurity A: NMT 0.10% | ND |
| Impurity B: NMT 0.10% | ND | |
| Impurity D: NMT 0.30% | 0.17% | |
| Impurity E: NMT 0.10% | ND | |
| Unspecified impurity F: NMT 0.10% | 0.03% | |
| Unspecified impurity G: NMT 0.10% | ND | |
| Pneumocandin B0: NMT 0.10% | ND | |
| Each of unspecified impurity : NMT 0.10% | 0.04% | |
| Total impurity: NMT 1.0% | 0.24% | |
| Related substances II | Impurity C: NMT 0.10% | 0.03% |
| Acetic acid | 9.0%~11.0%(calculated on anhydrous basis) | 10.1% |
| Heavy Metal as Pb | NMT 10ppm | Conforms |
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Notice: This product is only suitable for laboratory use, or the use of animals. It can not be used directly on the human body
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