CAS: 65277-42-1
EINECS: 265-667-4
MF: C26H28Cl2N4O4
MW: 531.43
Assay: 99% min.
Standard: EP/BP/USP
Packing: 25Kg/cardboard drum
Character: White crystalline powder. Melting point 146 ºC, insoluble in water.
Usage: Imidazole antifungal agents. For the treatment of conditions such as athlete's foot and excessive dandruff.
Ketoconazole is an imidazole fungicidal agent with a very broad spectrum of activity against many fungal species that is used for treatment of superficial and systemic fungal infections. Ketoconazole is a well documented cause of clinically apparent acute drug induced liver injury and is no longer recommended as a first line antifungal agent.
Inhibits cytochrome P-450 dependent steps in the biosynthesis of steroid hormones in vivo. Antimetastatic and antineoplastic activity. Orally active 5-lipoxygenase and thromboxane synthase inhibitor
Clinical application for treatment of hand eczema, athlete's foot, skin, ringworm, tinea, jock itch, thrush, tinea versicolor and cutaneous candidiasis.
COA:
Items
|
Standard
|
Results
|
Characters
|
White or almost white powder
|
Qualified
|
Identification
|
Meets the requirements
|
Qualified
|
Melting range
|
148°C ~ 152°C
|
148.0~ 150.0°C
|
Appearance of solution
|
Meets the requirements
|
Qualified
|
Organic volatile impurities
|
Meets USP30
|
Qualified
|
Specific rotation
|
-1° ~ +1°
|
0°
|
|
-0.10° ~ +0.10°
|
|
Chromatographic purity
|
Meets the requirements
|
Qualified
|
Heavy metals
|
≤0.002%
|
Qualified
|
Loss on drying
|
≤0.5%
|
0.1%
|
Residue on ignition
|
≤0.1%
|
0.05%
|
Assay
|
98.0% ~ 102.0%
|
99.69%
|
|
99.0%~101.0%
|
|
CONCLUSION:
|
USP30
|