Pharmaceutical Intermediates 65277-42-1 Ketoconazole Hair Loss Treatment Powder
Quick Detail:
Synonyms: ketoderm; nizoral
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 |
|
Description:
Ketoconazole is a broad-spectrum antifungal imidazole with commercially available product being under the trade name of Jindakening, Meikangling and keNing. It interferes with the activity of fungal cytochrome P-450 with a high selectivity, thus inhibiting the biosynthesis of ergosterol in fungal cell membrane.
Ketoconazole is effective in treating both shallow, deep fungal infections and can inhibit both fungal growth and the transition from spores to mycelium to prevent the further infection. It has antifungal effect on Candida genus, Fonsecaea, Coccidioides, Histoplasma, Sporothrix spp and Trichophyton. Clinically, it is suitable for the treatment of ringworm, athlete's foot, and skin ringworm, tinea, jock itch, and thrush, tinea versicolor as well as cutaneous candidiasis.
Application:
Ketoconazole lotion, as a skin external use, is mainly used for clinical treatment and prevention of various kinds of infections caused by Malassezia such as tinea versicolor, seborrheic dermatitis and scalp pityriasis (dandruff), and can quickly alleviate the desquamation and itching caused by seborrheic dermatitis and scalp pityriasis.