Ketoconazole is a synthetic aromatic ethyl cyclic ketal compound. Ketoconazole powder is off-white crystalline powder, odorless and tasteless. This product is soluble in chloroform and methanol, and is almost insoluble in water.
It has a wide antifungal spectrum, especially strong antibacterial activity against various superficial fungi, such as Malassezia, dermatophytes and Candida. Its mechanism of action is to inhibit the biosynthesis of ergosterol in the fungal cell membrane and affect the permeability of its cell membrane to achieve the purpose of inhibiting its growth. In addition, it also has a direct anti-inflammatory effect.

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Test Items |
Standard |
Test Results |
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Characteristics |
White or off-white powder |
Complies |
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Identification |
IR Complies |
Complies |
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Solubility |
Complies |
Complies |
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Melting point |
148~152℃ |
149~151℃ |
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Specific Rotation |
-1~+1° |
-0.02° |
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Loss on drying(w/w) |
≤0.5% |
0.23% |
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Residue on ignition |
≤0.1% |
0.04% |
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Heavy metals |
≤0.002% |
Complies |
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Chromatographic purity |
A,B Complies |
Complies |
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Particle Size |
-- |
100% through 400 mesh |
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Residual solvents |
Methanol ≤ 3000ppm Acetone ≤ 5000ppm Methyl Chloride ≤ 600ppm Ethyl acetate ≤ 5000ppm Toluene ≤ 890ppm |
Complies |
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Assay |
98.0~102%(on dried basis) |
100.47% |
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Conclusion |
Complies with USP standard. |
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1. Ketoconazole works by inhibiting or killing fungi in fungal skin diseases. It can inhibit the lipase activity secreted by Propionibacterium acnes and Malassezia, thereby blocking the inflammatory response and acne formation mediated by oleic acid and palmitic acid.
2. Anti-inflammatory effect. The 2016 Asian consensus on the treatment of seborrheic dermatitis recommends ketoconazole lotion as the first choice for mild seborrheic dermatitis. The European guidelines recommend antifungal treatment of atopic dermatitis of the head and neck, and ketoconazole can be used topically.
3. Clinical studies have shown that ketoconazole can play a role in the treatment of androgenic alopecia through anti-androgen mechanisms.
4. In addition to its bactericidal and antibacterial effects, it can also relieve itching and dandruff, making it an ideal auxiliary drug for treating tinea capitis in children.
The European Society of Paediatric Dermatology's Practice Guidelines for the Treatment of Tinea Capitis and the British Association of Dermatologists' Guidelines for the Management of Tinea Capitis indicate that 2% ketoconazole lotion can be used as an auxiliary topical drug for tinea capitis.
5. Ketoconazole powder also has good clinical value in the treatment of scalp psoriasis.
What is ketoconazole powder used for?
1. Ketoconazole lotion, for topical use in the treatment of seborrheic dermatitis or scalp.
Its effectiveness and safety have been confirmed in 20 randomized controlled trials.
2. Compound ketoconazole hair lotion contains two main ingredients: ketoconazole and glucocorticoids.
3. Ketoconazole suppositories and cream.






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