Active Pharmaceutical Ingredient

Ketoconazole

Also known as: Nizoral / Extina

CAS: 65277-42-1 Imidazole Antifungal IP / BP / EP / USP Bulk Supply Available
Ketoconazole API Manufacturer India | Mediocon Inc
Ketoconazole — Pharmaceutical Grade API

Product Overview

CAS No: 65277-42-1  |  MF: C₂₆H₂₈Cl₂N₄O₄  |  MW: 531.43 g/mol

Ketoconazole is an imidazole antifungal agent used topically for dermatophytosis, seborrheic dermatitis, and tinea infections. Systemically it inhibits fungal ergosterol synthesis and adrenal steroidogenesis. Mediocon Inc supplies high-purity Ketoconazole API meeting IP/BP/EP/USP standards for cream, shampoo, and tablet formulations.

Key Features

  • Broad-spectrum imidazole antifungal
  • IP/BP/EP/USP compliant quality
  • Suitable for topical and systemic formulations
  • Low impurity profile for dermatology use

Applications

  • Dermatophytosis and tinea infections
  • Seborrheic dermatitis and dandruff shampoo
  • Candidiasis (mucocutaneous)
  • Cushing's syndrome (off-label systemic use)

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameKetoconazole
Also Known AsNizoral / Extina
CAS Number65277-42-1
Molecular FormulaC₂₆H₂₈Cl₂N₄O₄
Molecular Weight531.43 g/mol
CategoryImidazole Antifungal
AppearanceWhite or Slightly Beige Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay98.5% – 101.5%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
pHN/A
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Packing25 kg HDPE drums / as per requirement
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