Active Pharmaceutical Ingredient

Fluconazole

Also known as: Diflucan (brand)

CAS: 86386-73-4 Antifungal IP / BP / USP Bulk Supply Available
Fluconazole API Manufacturer India | Mediocon Inc
Fluconazole — Pharmaceutical Grade API

Product Overview

CAS No: 86386-73-4  |  MF: C₁₃H₁₂F₂N₆O  |  MW: 306.27 g/mol

Fluconazole is a triazole antifungal agent that selectively inhibits fungal cytochrome P450-dependent enzyme lanosterol 14α-demethylase, disrupting ergosterol biosynthesis. It is widely used against Candida species, Cryptococcus, and dermatophytes.

Mediocon Inc manufactures Fluconazole IP/BP/USP as a high-purity API for pharmaceutical manufacturers producing antifungal formulations for domestic and international markets. Our quality management system ensures consistent potency, identity, purity, and safety testing per pharmacopoeial standards.

Key Features

  • Triazole class antifungal
  • Inhibits ergosterol biosynthesis
  • Broad antifungal spectrum
  • Both oral and IV formulation compatible

Applications

  • Candidiasis oral/vaginal/systemic treatments
  • Cryptococcal meningitis therapy
  • Antifungal prophylaxis formulations
  • Dermatophyte infection treatment

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 NameFluconazole
CAS Number86386-73-4
Molecular FormulaC₁₃H₁₂F₂N₆O
Molecular Weight306.27 g/mol
CategoryAntifungal
AppearanceWhite or Almost White Crystalline Powder
GradeIP / BP / USP
Packaging25 kg HDPE Drums / Aluminium Bags
StorageCool, Dry & Ventilated Place

Analytical Specifications

ParameterSpecification
AssayNLT 99.0% (Anhydrous Basis)
Water ContentNMT 0.5%
Heavy MetalsNMT 10 ppm
Residual SolventsComplies ICH Q3C
Microbial LimitsComplies
IdentificationIR & HPLC Compliant
Melting Point138 – 140 °C
Packing25 kg HDPE drums / as per requirement
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