| Product Name | Ketoconazole |
| Synonyms | Fungarest,Fungoral,Ketoconazol,Ketoderm, Ketoisdin,Nizoral,Ketoconazole |
| CAS | 65277-42-1 |
| EINECS | 265-667-4 |
| MF | C26H28Cl2N4O4 |
| MW | 531.43 |
| Appearance | Almost White Crystalline Powder |
| Melting Point | 146ºC |
| Usage | Inhibits cytochrome P-450 dependent steps in the biosynthesis of steroid hormones in vivo. Antimetastatic and antineoplastic |
Ketoconazole is a synthetic antifungal drug used primarily to treat fungal infections. Ketoconazole is sold commercially as a tablet for oral administration (although this use has been discontinued in a number of countries), and in a variety of formulations for topical administration, such as creams (used to treat tinea; cutaneous candidiasis, including candidal paronychia; and pityriasis versicolor) and shampoos (used primarily to treat dandruff-seborrhoeic dermatitis of the scalp).
Ketoconazole is used to treat certain serious fungal infections in the body. Ketoconazole belongs to the class of drugs called azole antifungals. It works by stopping the growth of the fungus.
| Contents | Standard | Results of analysis |
| Appearance | White or yellowish powder | Kind of white powder |
| Identification | Comply with the standard | Conform |
| Optical rotation | -0.05~+0.05° | 0.00° |
| Appearance of solution | Comply with the standard | Conforms |
| Sulphated ash | <0.1% | 0.05% |
| 2-Pro | <0.7% | Conform |
| Heavy metals | <20ppm | Conform |
| Individual impurity | <0.3% | 0.09% |
| <0.1 Impurity count | <2% | Conform |
| Assay | 98.5~100.5% | 99.64% |
| Result: Conform to USP |
China
