Trusted Clotrimazole Extract Manufacturer | Bulk Supply & Verified Factory
1. Product Overview: Clotrimazole
English Name: Clotrimazole
CAS Number: 23593-75-1
Molecular Formula: C22H17ClN2
Appearance: White to off-white crystalline powder
Solubility: Slightly soluble in water, soluble in ethanol, chloroform, and DMSO
Purity: ≥ 99% (HPLC)
Supplier: Shaanxi Zhonghong Investment Technology Co., Ltd.
Clotrimazole is a widely used antifungal agent in pharmaceuticals, personal care, and veterinary industries. It belongs to the imidazole class and is effective against a broad spectrum of fungal infections. This product page is optimized for B2B buyers seeking bulk, high-quality, and certified Clotrimazole for their formulations.
2. Source and Production
Clotrimazole is synthetically manufactured under cGMP-compliant facilities. Shaanxi Zhonghong Investment Technology Co., Ltd. has over 15 years of experience in producing pharmaceutical-grade antifungal agents. Our production lines ensure consistent quality, purity, and stability, verified by internal QC and third-party testing.
Production Process (Simplified Flow):
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Raw material synthesis via imidazole derivatives
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Crystallization under controlled conditions
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Filtration and drying
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Pulverization to fine powder
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Packaging under controlled humidity
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Quality control and COA issuance
3. Health Benefits and Applications
Clotrimazole Benefits:
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Broad-spectrum antifungal activity
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Effective against Candida spp., dermatophytes, and Malassezia
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Supports treatment of skin, nail, and mucosal fungal infections
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Commonly formulated into creams, lotions, gels, powders, and sprays
Traditional Applications:
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Topical creams for athlete’s foot, ringworm, jock itch
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Vaginal antifungal treatments
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Incorporation in cosmetic formulations for skin microbiome balance
Recommended Dosage & Formulation Guidelines:
| Formulation Type | Typical Clotrimazole Content | Notes |
|---|---|---|
| Cream/Lotion | 1-2% | For topical dermatological use |
| Powder | 1-5% | For antifungal foot powders |
| Gel | 1-2% | Ensure uniform dispersion |
| Vaginal suppository | 100-200 mg per unit | Follow pharmacopeia standards |
Best Formulation Practices:
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Use emulsifiers compatible with imidazoles for stable creams
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Maintain pH 5-7 for optimal activity
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Protect from moisture and light during processing
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Conduct stability testing for 12–24 months shelf life
4. Product Specifications and COA
Clotrimazole Typical COA:
A. Physicochemical Parameters
| Parameter | Specification | Method |
|---|---|---|
| Appearance | White to off-white crystalline powder | Visual |
| Purity | ≥ 99% | HPLC |
| Melting Point | 143-147°C | USP |
| Loss on Drying | ≤ 0.5% | AOAC 925.10 |
| Residue on Ignition | ≤ 0.1% | USP |
B. Pesticide Residues
| Name | Limit | Method |
|---|---|---|
| Total Pesticides | ≤ 0.01% | GC-MS |
| Specific Residues | Complies with USP/EP | HPLC/GC |
C. Heavy Metals
| Name | Limit | Method |
|---|---|---|
| Lead (Pb) | ≤ 10 ppm | ICP-MS |
| Arsenic (As) | ≤ 2 ppm | ICP-MS |
| Mercury (Hg) | ≤ 1 ppm | ICP-MS |
| Cadmium (Cd) | ≤ 1 ppm | ICP-MS |
D. Microbiological Quality
| Microorganism | Limit | Method |
|---|---|---|
| Total Plate Count | ≤ 1000 CFU/g | AOAC 990.12 |
| Yeast & Mold | ≤ 100 CFU/g | AOAC 997.02 |
| E. coli | Negative | USP <62> |
| Salmonella | Negative | USP <62> |
| Staphylococcus aureus | Negative | USP <62> |
5. Storage, Shelf Life, and Packaging
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Storage Conditions: Cool, dry, dark environment; avoid direct sunlight
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Shelf Life: 24 months from production date
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Packaging Options:
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25 kg/drum (standard)
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Custom packaging available for large-scale orders
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Sample Policy: Small sample (<10 g) available upon request
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Minimum Order Quantity (MOQ): 1 kg for bulk procurement
6. Transportation
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Complies with international shipping regulations for non-hazardous pharmaceutical intermediates
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Can be shipped via air, sea, or express courier with full documentation
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COA, MSDS, and packing list provided
7. Industry Applications and Usage Scenarios
Applicable Industries:
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Pharmaceutical manufacturers (creams, tablets, vaginal suppositories)
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Cosmetic manufacturers (anti-dandruff, antifungal creams)
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Veterinary products (topical antifungal powders and sprays)
Usage Method:
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Dissolve or disperse in suitable excipients per formulation
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Ensure proper mixing, pH adjustment, and sterilization when required
Customer Case Study (Experience-Based):
A European pharmaceutical company incorporated our Clotrimazole into a 1% antifungal cream. Stability testing over 12 months confirmed >99% potency with zero microbial contamination.
8. Certifications and Authority
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cGMP Certified Facility
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COA and MSDS for each batch
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Tested according to USP, EP standards
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References: FDA Guidance on Topical Antifungals, PubMed: Clotrimazole Antifungal Studies, NIH Research
Brand Credibility: Shaanxi Zhonghong Investment Technology Co., Ltd. has 15+ years supplying pharmaceutical intermediates to Europe, North America, and Asia, with factory audits, real product photos, and verifiable contact information.
9. Frequently Asked Questions (FAQ)
Q1: What is the recommended Clotrimazole concentration for creams?
A: Typically 1-2% by weight for topical formulations.
Q2: Is Clotrimazole safe for all age groups?
A: Topical formulations are generally safe; oral and systemic use requires medical supervision.
Q3: What is the MOQ for bulk purchase?
A: 1 kg, with larger quantities available per request.
Q4: Can you provide COA and third-party testing?
A: Yes, every batch comes with a full COA, MSDS, and microbiological report.
Q5: How should it be stored?
A: In a cool, dry, and dark environment, away from moisture and heat.
10. References
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PubMed – Clotrimazole Antifungal Research
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USP 43 – Clotrimazole Standards and Testing
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European Pharmacopoeia (EP 10.0) – Clotrimazole Monograph
