Product Name: Ketoconazole
Synonyms:Nizoral
Purity: 99%
Cas No: 65277-42-1;79156-75-5
Einecs No: 265-667-4
Molecular formula: C26H28Cl2N4O4
Molecular weight: 409.4
Ketoconazole is a synthetic imidazole 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.
(1) Topical antifungal
(2) Systemic antifungal
(3) Antiandrogenic and antiglucocorticoid
(4) Veterinary
Other Uses
This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional. This drug may also be used to treat advanced prostate cancer.
| ITEMS |
SPECIFICATIONS |
RESULTS |
| Appearance |
Off white powder or crystalline powder |
Conform |
| Identification |
IR test |
Conform |
| Specific rotation |
-1°~ +1° |
0° |
| Melting range |
148℃-152℃ |
148.0℃-149.9℃ |
| Loss on drying |
≤0.5% |
0.04% |
| Residue on ignition |
≤0.1% |
0.03% |
| Heavy metals |
≤0.002% |
＜0.001% |
| Chromatographic purity |
≤2% |
Conform |
| Assay |
98.0%-102.0% |
99.8% |
| Organic volatile impurities |
A: Ethanol |
≤0.5% |
＜0.5% |
|
B: Ethyl Acetate |
≤0.2% |
＜0.2% |
|
C: Dichloromethane |
≤0.006% |
＜0.006% |
| Conclusion |
Conform to USP 32 |
