Clotrimazole Cas 23593-75-1
Specification
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 | Complies |
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. |
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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.
How It Works (Mechanism of Action)
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.
Primary Uses and Applications
Clotrimazole is available in various formulations for topical (on the skin/mucous membranes) and, less commonly, oral use.
1. Topical Uses (Most Common)
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:
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.
2. Other Uses
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.
Available Forms & Key Points
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.
Safety, Side Effects, and Considerations
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.
Summary
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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Contact information
Spring Zhang
Email: export@fortunachem.com
Skype: Fortunachem201304
QQ:3169620873
Tel: +86-27-59207892
Website: www.fortunachem.com
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