Clotrimazole API (CAS 23593-75-1) | GMP-Certified Bulk Supplier & Manufacturer

Clotrimazole is a widely used pharmaceutical active ingredient (API) manufactured for antifungal drug formulations, including topical creams, ointments, powders, and vaginal dosage forms. AIHerba® supplies high-purity Clotrimazole powder (≥99% HPLC) under GMP-controlled production, meeting USP / BP / EP pharmacopeial requirements for global pharmaceutical manufacturers.

As a China-based bulk Clotrimazole supplier and OEM partner, AIHerba supports stable long-term supply, complete COA documentation, and regulatory-compliant manufacturing for finished dosage producers, contract manufacturers (CMOs), and international distributors. Our Clotrimazole raw material is produced with strict quality control, traceable sourcing, and batch-to-batch consistency, ensuring suitability for regulated pharmaceutical applications.

If you are sourcing Clotrimazole API in bulk, require custom specifications, or need fast samples and technical documentation, AIHerba provides a reliable, export-ready solution.

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1. What Is Clotrimazole?

Clotrimazole is an imidazole-class antifungal pharmaceutical ingredient used as a synthetic API in external and mucosal antifungal formulations. It is recognized globally in pharmacopeial standards and included in numerous finished dosage products manufactured for regulated markets.

• INN Name: Clotrimazole

• Chemical Class: Imidazole derivative

• CAS Number: 23593-75-1

• Molecular Formula: C₂₂H₁₇ClN₂

• Appearance: White to off-white crystalline powder

⚠️ This page focuses on raw material manufacturing and supply. Therapeutic claims are determined by finished product formulation and regulatory approval.

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2. Product Source & Manufacturing Origin

AIHerba® Clotrimazole API is manufactured in China by Shaanxi Zhonghong Investment Technology Co., Ltd., operating under:

• GMP-compliant production systems

• Controlled synthetic chemistry processes

• Validated analytical testing laboratories

Our facilities support pharmaceutical raw material exports to North America, EU, Southeast Asia, Middle East, and Latin America.

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3. Mechanism of Action (Scientific Overview)

From a pharmaceutical science perspective, Clotrimazole functions by:

• Interfering with ergosterol biosynthesis in fungal cell membranes

• Altering membrane permeability and enzyme activity

This mechanistic description is provided for technical understanding only, supporting formulation research and regulatory documentation.

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4. Benefits for Formulation & Manufacturing (Non-Therapeutic)

From a B2B manufacturing standpoint, Clotrimazole offers:

• Proven chemical stability in topical dosage forms

• Compatibility with standard pharmaceutical excipients

• Suitability for cream, ointment, powder, and suppository formulations

• Established regulatory history, simplifying DMF and dossier preparation

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5. Usage Guidelines (For Manufacturers Only)

Clotrimazole is used exclusively by qualified pharmaceutical manufacturers.
Typical use considerations include:

• API incorporation into finished dosage formulations

• Concentration levels defined by pharmacopeia and local regulations

• Stability and compatibility testing required before commercialization

⚠️ Not intended for direct consumer use.

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6. Traditional & Historical Context

Clotrimazole was developed as part of modern antifungal pharmaceutical research, not traditional herbal medicine. Its relevance lies in synthetic pharmaceutical innovation, supported by decades of clinical and regulatory evaluation.

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7. Recommended Dosage (Regulatory Context)

Dosage levels are formulation-specific and determined by:

• Pharmacopeial standards (USP / BP / EP)

• Local drug regulatory authorities

• Clinical formulation design

AIHerba does not provide medical dosage recommendations.

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8. Formulation & Compatibility Guide

Clotrimazole is commonly formulated with:

• Emulsifying agents (for creams)

• Pharmaceutical-grade solvents

• Stabilizers and preservatives

We provide technical support for formulation compatibility upon request.

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9. Safety & Handling Considerations

• For industrial and pharmaceutical use only

• Handle in compliance with MSDS guidelines

• Use appropriate PPE during processing

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10. Product Specifications & COA

Basic Specifications

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Pesticide Residue Testing

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Heavy Metals

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Microbiological Limits

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11. Production Process (Overview)

1. Raw material qualification

2. Controlled synthetic reaction

3. Crystallization & purification

4. Drying under controlled conditions

5. Milling & sieving

6. In-process QC testing

7. Final QC release & packaging

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12. Storage, Shelf Life & Packaging

• Storage: Cool, dry, light-protected environment

• Shelf Life: 24–36 months

• Packaging:

  • 1 kg aluminum foil bag

  • 25 kg fiber drum

  • Custom packaging available

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13. Samples, MOQ & Logistics

• Sample Policy: Free lab samples (courier cost borne by buyer)

• MOQ: 1 kg

• Shipping: Air / Sea / Express

• Export Documents: COA, MSDS, GMP, TDS

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14. Clinical Data & Regulatory Background

Clotrimazole has been extensively studied and documented in international literature.
For reference only:

• PubMed

• FDA

• NIH

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15. Applicable Industries & Use Scenarios

• Pharmaceutical manufacturers

• Contract Manufacturing Organizations (CMOs)

• Generic drug producers

• OTC antifungal product developers

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16. Why Choose AIHerba®

• ✅ GMP-certified pharmaceutical manufacturing

• ✅ 28+ years of R&D and export experience

• ✅ Batch traceability & full documentation

• ✅ Stable bulk supply & OEM support

• ✅ Trusted by global B2B buyers

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17. Frequently Asked Questions (FAQ)

1. Is your Clotrimazole compliant with USP/BP/EP?
Yes, specifications can be aligned to pharmacopeial requirements.

2. Do you provide DMF support?
Technical documentation support is available upon request.

3. What is your typical lead time?
3–7 working days for standard orders.

4. Can you support custom specifications?
Yes, OEM and customized parameters are supported.

5. Is this product suitable for export to EU/US?
Yes, with complete regulatory documentation.

6. Can I audit your factory?
Remote and on-site audits are supported by appointment.

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18. References & Regulatory Resources

1. PubMed – https://pubmed.ncbi.nlm.nih.gov

2. FDA Drug Database – https://www.fda.gov

3. NIH – https://www.nih.gov

4. USP–NF Monographs

5. FDA – Topical Antifungal Drug Guidance

6. PubMed – Clotrimazole Antifungal Research

7. NIH – Pharmacology and Toxicology of Clotrimazole

8. USP 43 – Clotrimazole Standards and Testing

9. European Pharmacopoeia (EP 10.0) – Clotrimazole Monograph

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Contact AIHerba® – Reliable Clotrimazole API Supplier

AIHerba® | China Natural Plant Extracts Supplier & OEM Factory
Shaanxi Zhonghong Investment Technology Co., Ltd.

📧 sales@aiherba.com
📧 info@aiherba.com
📧 liaodaohai@gmail.com
🌐 www.aiherba.com