Miconazole Nitrate Micronized USP-43 (CAS 22832-87-7)

Miconazole Nitrate is an antifungal API (Active Pharmaceutical Ingredient) used in antifungal creams and lotions.
SKU: MICONAZOL
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Miconazole Nitrate USP-43

Miconazole Nitrate USP-43 is a high-purity pharmaceutical active ingredient (API) belonging to the imidazole class of antifungal agents. It is widely used in the formulation of topical and mucosal antifungal medications for the treatment of dermatological and yeast infections.

This material conforms to USP-43 specifications, making it suitable for use in regulated pharmaceutical manufacturing environments and compounding applications. It is micronized to provide better dispersion, smoother texture, and improved bioavailability in topical systems.

Miconazole Nitrate exhibits broad-spectrum antifungal activity, targeting both dermatophytes and yeasts by disrupting fungal cell membrane synthesis.

Key Applications

Pharmaceutical Formulations

  1. Athlete’s foot (tinea pedis) creams and sprays
  2. Ringworm (tinea corporis) treatments
  3. Jock itch (tinea cruris) formulations
  4. Vaginal antifungal creams and suppositories
  5. Oral antifungal gels (e.g., for thrush)

Compounding Pharmacy Use

  1. Custom antifungal creams and gels
  2. Combination dermatological formulations

Personal Care & Medicated Cosmetics

  1. Antimicrobial creams
  2. Medicated skincare products

Veterinary Applications

  1. Treatment of fungal infections in animals

Research & Development

  1. Antifungal formulation development
  2. Academic and pharmaceutical research

Mechanism of Action (Technical Insight)

Miconazole Nitrate inhibits the biosynthesis of ergosterol, a critical component of fungal cell membranes. This disruption compromises membrane integrity, leading to leakage of cellular contents and fungal cell death.

This well-established mechanism contributes to:

  1. Broad-spectrum antifungal efficacy
  2. Reliable performance in topical formulations
  3. Proven clinical effectiveness

This product is ideal for:

  1. Pharmaceutical manufacturers (OTC and generic drug producers)
  2. Contract manufacturing organizations (CMOs/CDMOs)
  3. Compounding pharmacies
  4. Cosmetic and personal care manufacturers
  5. Veterinary product manufacturers
  6. Universities and research laboratories
  7. Chemical distributors and resellers

Product Specifications

Product Name Miconazole Nitrate
CAS Number 22832-87-7
Grade USP-43
Chemical Class Imidazole antifungal
Appearance White to off-white crystalline powder
Assay (Typical) 98.0% – 102.0% (USP range)
Solubility Slightly soluble in water; soluble in organic solvents such as ethanol, propylene glycol and DMSO
Molecular Formula C₁₈H₁₄Cl₄N₂O·HNO₃
Particle size D90 = 10µm

Quality & Compliance

  1. Manufactured to USP-43 standards
  2. Suitable for regulated pharmaceutical applications
  3. Consistent batch-to-batch quality

Available Documentation:

Certificate of Analysis (CoA)
Safety Data Sheet (SDS)
Technical Data Sheet (TDS)

Packaging Options

Original product (Made in China) comes in 25 kg fiber drums. We repackage and offer smaller quantities to support Research and Development market:

Education and small R&D Quantities: 5 g, 25 g
Large R&D Quantities: 1 kg, 10 kg
Bulk Supply for drug manufacturing: 25 kg fiber drums

Custom packaging and private labeling available upon request for educational and research market.

Formulation Considerations

Miconazole Nitrate is commonly used in:

  1. Oil-in-water creams
  2. Gels and lotions
  3. Suppositories and vaginal formulations

Key formulation notes:

  1. Often combined with solvents such as propylene glycol
  2. Compatible with common emulsifiers and thickening agents
  3. Particle size may impact dispersion and bioavailability

Why Buy From Chemical Store?

  • Reliable supply of pharmaceutical-grade materials
  • Flexible packaging for research and educational market
  • 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

Refer to the SDS for complete safety and handling information.

Regulatory & Usage Notice

This product is intended for:

  1. Pharmaceutical manufacturing
  2. Compounding and laboratory use
  3. Antifungal drug research

Not intended for direct consumer use.
Buyers are responsible for ensuring compliance with all applicable regulations in their jurisdiction.

  • Availability: In Stock
  • Model: MICONAZOL
  • Brand: ChemicalStore
FAQ
Q: What is the typical concentration of Miconazole Nitrate Micronized USP-43 in a pharmaceutical formulation?
A: The typical concentration of Miconazole Nitrate Micronized USP-43 can vary depending on the specific application and desired antifungal activity. However, it is commonly formulated at concentrations ranging from 0.01% to 3.0% in creams, ointments, and gels for topical use.

Q: Can Miconazole Nitrate Micronized USP-43 be used in combination with other APIs or excipients?
A: Yes, Miconazole Nitrate Micronized USP-43 can be used in combination with other APIs or excipients, such as antihistamines, analgesics, or moisturizers, in a pharmaceutical formulation. However, it is essential to ensure compatibility and stability by conducting thorough testing and stability studies to confirm the efficacy and safety of the final product.

Q: What is the recommended storage condition for Miconazole Nitrate Micronized USP-43 to maintain its potency and shelf life?
A: Miconazole Nitrate Micronized USP-43 should be stored in a dry, cool place (20°C to 25°C) away from direct sunlight and moisture. It is recommended to store the product in a well-closed container to prevent degradation and contamination. Proper storage and handling are crucial to maintaining the product's potency and shelf life, which typically ranges from 2 to 5 years from the date of manufacture.

Q: Why Buy From Chemical Store?
A: Reliable supply of pharmaceutical-grade materials. Flexible packaging options tailored for the research and educational market. Strong technical understanding of formulation applications. Responsive support for documentation and compliance needs. Suitable for both established manufacturers and small-scale developers.