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Miconazole Nitrate is an antifungal API (Active Pharmaceutical Ingredient) used in antifungal creams and lotions.
Miconazole Nitrate Micronized USP-43
Miconazole Nitrate Micronized USP-43 is a pharmaceutical-grade antifungal active ingredient (API) belonging to the imidazole class of antifungal compounds. It is commonly used in topical and mucosal antifungal formulations for pharmaceutical manufacturing, compounding, formulation development, and laboratory applications.
This material conforms to USP-43 specifications and is micronized to provide improved dispersion, enhanced uniformity, and smoother incorporation into topical and semi-solid formulations.
Miconazole Nitrate exhibits broad-spectrum antifungal activity against dermatophytes and yeasts through inhibition of ergosterol biosynthesis, an essential component of fungal cell membranes.
Key Applications
Pharmaceutical Formulations
- Topical antifungal creams and lotions
- Athlete’s foot (tinea pedis) formulations
- Ringworm (tinea corporis) products
- Jock itch (tinea cruris) products
- Vaginal antifungal creams and suppositories
- Antifungal sprays, powders, and gels
Compounding Pharmacy Use
- Custom antifungal creams and gels
- Combination dermatological formulations
Personal Care & Cosmeceutical Applications
- Medicated skincare products
- Antimicrobial topical formulations
Veterinary Applications
- Antifungal formulations for veterinary use
Research & Development
- Antifungal formulation development
- Pharmaceutical and academic research
Technical Information
Miconazole Nitrate inhibits the biosynthesis of ergosterol, an essential component of fungal cell membranes. This disruption compromises membrane integrity and contributes to antifungal activity in topical pharmaceutical systems.
Key Features:
- USP-43 pharmaceutical grade
- Micronized particle size for improved dispersion
- Consistent batch-to-batch quality
- Suitable for multiple topical dosage forms
- Broad-spectrum antifungal activity
This product is ideal for:
- Pharmaceutical manufacturers
- Contract manufacturing organizations (CMOs/CDMOs)
- Compounding pharmacies
- Cosmetic and personal care manufacturers
- Veterinary product manufacturers
- Universities and research laboratories
- Chemical distributors and resellers
Product Specifications
| Product Name | Miconazole Nitrate Micronized USP-43 |
| CAS Number | 22832-87-7 |
| EC Number | 245-256-6 |
| Grade | USP-43 |
| Chemical Class | Imidazole antifungal |
| Appearance | White to off-white crystalline powder |
| Assay | 98.0% – 102.0% (USP specification) |
| Typical Assay | 99.85% |
| Solubility | Slightly soluble in water; soluble in organic solvents such as ethanol, propylene glycol, PEG systems, and DMSO |
| Molecular Formula | C₁₈H₁₄Cl₄N₂O·HNO₃ |
| Molecular Weight | 479.14 g/mol |
| Particle Size | D90 = 10 µm |
| Melting Point | Approximately 178–182°C |
Quality & Compliance
- Manufactured in accordance with USP-43 specifications
- Packaged for pharmaceutical, compounding, and research applications
- Consistent batch-to-batch quality
Available Documentation:
Certificate of Analysis (CoA)
Safety Data Sheet (SDS)
Technical Data Sheet (TDS)
Packaging Options
Original material is manufactured in China and supplied in 25 kg fiber drums. Smaller repackaged quantities are available to support research, development, pilot-scale work, and formulation testing.
1oz – $49
1lb – $295
55lb (25 kg Drum) – $4495
Custom packaging and private labeling may be available upon request for research and industrial applications.
Formulation Considerations
Miconazole Nitrate is commonly incorporated into:
- Oil-in-water creams
- Gels and lotions
- Vaginal formulations
- Powder sprays and topical systems
Key formulation notes:
- Often pre-dispersed in propylene glycol or PEG systems
- Compatible with common emulsifiers and thickening agents
- Micronized particle size may improve formulation uniformity and dispersion
Why Buy From Chemical Store?
- Reliable supply of pharmaceutical-grade materials
- Flexible packaging for research and development applications
- Technical understanding of formulation applications
- Responsive support for documentation and compliance needs
- Ideal for both established manufacturers and small-scale developers
Related Products
To support antifungal formulation development, consider:
- Carbomers (gel base thickening agents)
- Emulsifiers (cream formulations)
- Propylene glycol (solvent and penetration enhancer)
- Preservatives and stabilizers
Storage & Handling
- Store in a cool, dry, well-ventilated area
- Protect from moisture and direct sunlight
- Keep container tightly closed
- Use appropriate PPE and avoid inhalation of dust
Refer to the SDS for complete safety and handling information.
Shipping Notice
Small quantities are typically shipped as non-regulated material for domestic ground transportation. Bulk quantities may require additional shipping review depending on destination, carrier requirements, and applicable regulations.
Regulatory & Usage Notice
This product is intended for:
- Pharmaceutical manufacturing
- Compounding applications
- Research and laboratory use
- Industrial formulation development
Not intended for direct consumer use or direct human consumption.
Buyers are responsible for ensuring compliance with all applicable local, state, federal, and international regulations regarding use, handling, formulation, labeling, and distribution.
Disclaimer
The information provided is believed to be accurate and reliable based on available supplier and internal documentation. Users are responsible for determining the suitability of this material for their specific application and for compliance with all applicable regulations.
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