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Pharmaceutical Chemistry
Clotrimazole
Formula:
C22H17ClN2
GOST/CAS:
CAS 23593-75-1
Clotrimazole is a highly effective, broad-spectrum antifungal (antimycotic) agent belonging to the imidazole derivative group. The product is a white to pale yellow, odorless crystalline powder, practically insoluble in water but readily soluble in organic solvents (such as ethanol and chloroform). Offering potent fungicidal and fungistatic properties, Clotrimazole serves as an essential active ingredient for formulating stable, high-performance products in the modern pharmaceutical and cosmeceutical industries.
Applications
Manufacturing of Topical Dosage Forms: Acts as the primary Active Pharmaceutical Ingredient (API) in antifungal creams, ointments, gels, and suppositories used to treat skin mycoses, skin folds, athlete's foot, and urogenital candidiasis.
Cosmeceuticals and Personal Care: Utilized as an active anti-dandruff component in specialized shampoos (targeting yeast-like fungi), scalp lotions, protective foot sprays, and powders.
Veterinary Medicine: Incorporated into antifungal ointments, drops, and sprays for treating dermatomarginal and various fungal infections in domestic and farm animals.
Pharmaceutical Solutions: Widely used in complex topical solutions designed for treating affected skin areas and nail plates.
Key Advantages
Broad-Spectrum Antimycotic Activity: Highly effective against dermatophytes, yeast-like fungi (including Candida species), and molds, while also demonstrating antibacterial action against staphylococci and streptococci.
High Stability and Compatibility: Blends seamlessly into various emulsion types (oil-in-water and water-in-oil), ointment bases, and alcohol solutions without losing its therapeutic efficacy, provided the system's pH is correctly maintained.
Safety and Targeted Local Action: When applied topically, it undergoes minimal systemic absorption through the skin and mucous membranes, ensuring a high concentration of the active substance directly at the site of infection.
Proven Therapeutic Efficacy: A time-tested substance with predictable outcomes, ensuring strong consumer trust and confidence in the final commercial product.
Storage & Transportation
- Store in dry, clean, cool warehouses in tightly sealed original packaging (light-resistant containers), protected from direct sunlight and away from heat sources.
- Recommended storage temperature: between +15°C and +25°C. Avoid sudden temperature fluctuations and moisture exposure to prevent powder caking.
- Prevent contact with strong oxidizing agents, alkalis, and acids, which can trigger degradation of the active substance.
- Transportation is suitable via all types of covered transport, provided temperature regulations are met. The product is transported in accordance with non-hazardous cargo regulations. Shelf life — 3 to 5 years from the manufacturing date (depending on the manufacturer's specification).
Technical Specifications
Appearance
White to almost white, odorless crystalline powder
Assay (Active Content)
98.5% – 101.5% (on dried basis)
Melting Point
141°C – 145°C
Loss on Drying
Not more than 0.5%
Sulfated Ash
Not more than 0.1%
Heavy Metals
Not more than 20 ppm
Residual Solvents
Complies with USP / EP requirements
Supply info
- Fiber drums (cardboard drums) with a double plastic inner liner containing 25 kg (the international standard for pharmaceutical raw materials).
- Custom packaging in aluminum foil bags of 1 kg / 5 kg is available for small-scale pilot production (upon agreement).