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Clotrimazole is a synthetic pyrrole antifungal drug that has inhibitory effects on a variety of pathogenic fungi. Clotrimazole has broad-spectrum antifungal activity, and has a good antibacterial effect on epidermophyton, trichophyton, aspergillus, pigmented fungus, cryptococcus, and candida, and also has certain antibacterial activities against sporothrix schenckii, Blastomyces dermatitidis, coccidioides immitis, Histoplasma, etc.
Clotrimazole has an inhibitory effect on a variety of pathogenic fungi, and can also have a bactericidal effect when the concentration is high. Clotrimazole inhibits the biosynthesis of sterols such as the fungus ergosterol by interfering with the activity of cytochrome P450; Damage the fungal cell membrane and change its permeability, resulting in the leakage of important substances in the cell; It can also inhibit the biosynthesis of triglycerides and phospholipids of fungi; It inhibits the activity of oxidation and peroxidase, causes excessive accumulation of peroxides in cells, causes degeneration and necrosis of fungal subcellular structures.
Items | Specifications | Results |
Appearance | White or pale yellow, crystalline powder | White crystalline powder |
Melting Point(℃) | 141~145℃ | 144~145℃ |
Identification | A.Infrared absorption:The IR spectrum of sample,exhibits maxima only at the same wavelength as that a similar preparation of USP Clotrimazole RS. | Complies |
B.HPLC:The retention time of the major peak of the sample solution Corresponds to that of the standard solution,as obtained in the assay. | Complies | |
Loss on Drying | NMT 0.5% | 0.1% |
Residue on Ignition | NMT 0.1% | 0.03% |
Heavy Metals | NMT 10 ppm | |
Limit of Imidazole | NMT 0.5% | Complies |
Limit Of Clotrimazole Related Compound A | NMT 0.5% | 0.022% |
Solubility | --- | Freely soluble in methanol,in chloroform.Soluble in alcohol,in acetone.Practically insoluble in water. |
Residual Solvent | --- | Benzene:0.000075% Acetone:0.054% |
Assay(on the dried basis) | 98.0%~102.0% | 99.1% |
Conclusion | The product conforms to the above specifications. | |
| Product parameters | |
| Cas number: | 23593-75-1 |
| Appearance: | White to pale yellow,crystalline powder |
| Purity: | 98%-102% |
| Package details: | 25kg/drum |
| Brand: | Fortunachem |
Clotrimazole is a broad-spectrum antifungal medication belonging to the imidazole class. It is primarily used to treat infections caused by fungi (like yeast and dermatophytes) and some gram-positive bacteria.
Clotrimazole works by damaging the cell membrane of fungal cells.
It inhibits the synthesis of ergosterol, a critical component of the fungal cell membrane.
Without proper ergosterol, the membrane becomes leaky and permeable, causing essential cellular components to leak out. This ultimately kills the fungus or inhibits its growth.
Clotrimazole is available in various formulations for topical (on the skin/mucous membranes) and, less commonly, oral use.
Used for superficial fungal infections of the skin, nails, and mucous membranes.
Cutaneous Candidiasis: Fungal skin infections like diaper rash, intertrigo (rash in skin folds), and infections around nails (paronychia).
Dermatophyte Infections: Treats tinea infections such as:
Athlete's foot (Tinea pedis)
Jock itch (Tinea cruris)
Ringworm (Tinea corporis)
Vaginal Yeast Infections: Available as vaginal creams, tablets, or suppositories for treating vulvovaginal candidiasis.
Oral Thrush: Available as a troche (lozenge) that is slowly dissolved in the mouth to treat Candida infections in the mouth and throat.
Otic Drops: Sometimes combined with an antibiotic (e.g., betamethasone/clotrimazole/gentamicin) to treat outer ear infections ("swimmer's ear") where fungus may be involved.
Limited Systemic Use: An oral tablet form exists but is rarely used systemically today due to the availability of safer, more effective oral antifungals. Its primary use remains topical.
Forms: Cream (1%, 2%), Lotion, Solution, Powder, Vaginal Cream/Tablets, Oral Troches, Combination Ear/Eye Drops.
Over-the-Counter (OTC): Many clotrimazole products for skin and vaginal use are available without a prescription.
Prescription Required: Oral troches and some higher-strength or combination formulations require a prescription.
Common Side Effects (Topical): Usually mild and localized, such as:
Redness, stinging, burning, itching, or irritation at the application site.
For vaginal use: mild burning, itching, or discharge.
Serious Side Effects (Rare): Severe skin irritation or allergic reactions (hives, difficulty breathing, swelling). Discontinue use and seek medical help if these occur.
Important Considerations:
For External Use: Most formulations are not for ophthalmic (eye) use unless specifically labeled as eye drops.
Complete the Course: Use for the full recommended time, even if symptoms improve quickly, to prevent recurrence.
Diagnosis: It's best to have a fungal infection confirmed by a doctor before starting treatment, especially for the first time.
Pregnancy/Breastfeeding: Generally considered safe for topical use during pregnancy and breastfeeding, but it's advised to consult a doctor first, especially for vaginal treatments.
Clotrimazole is a widely used, effective antifungal medication available over-the-counter in many forms. Its primary uses are for treating common skin fungal infections (like athlete's foot, jock itch, ringworm), vaginal yeast infections, and oral thrush. It works by disrupting the fungal cell membrane. While generally safe with minimal side effects, it is crucial to use it as directed and consult a healthcare provider for proper diagnosis of persistent or severe infections.



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