Active Pharmaceutical Ingredient

Itraconazole

Also known as: Sporanox / Onmel

CAS: 84625-61-6 Triazole Antifungal IP / BP / EP / USP Bulk Supply Available
Itraconazole API Manufacturer India | Mediocon Inc
Itraconazole — Pharmaceutical Grade API

Product Overview

CAS No: 84625-61-6  |  MF: C₃₅H₃₈Cl₂N₈O₄  |  MW: 705.64 g/mol

Itraconazole is a triazole antifungal agent with a broad spectrum of activity against dermatophytes, yeasts, and molds. It inhibits fungal CYP450-dependent lanosterol demethylase. Mediocon Inc supplies high-purity Itraconazole API meeting IP/BP/EP/USP standards for oral and topical formulations.

Key Features

  • Broad-spectrum triazole antifungal
  • IP/BP/EP/USP compliant quality
  • Effective against dermatophytes, yeasts, molds
  • Available in micronized form for better bioavailability

Applications

  • Systemic fungal infections (aspergillosis, candidiasis)
  • Onychomycosis (nail fungal infections)
  • Dermatophytosis
  • Blastomycosis and histoplasmosis

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 NameItraconazole
Also Known AsSporanox / Onmel
CAS Number84625-61-6
Molecular FormulaC₃₅H₃₈Cl₂N₈O₄
Molecular Weight705.64 g/mol
CategoryTriazole Antifungal
AppearanceWhite to Slightly Yellowish Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay98.0% – 102.0%
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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