Active Pharmaceutical Ingredient

Miconazole Nitrate API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 22832-87-7 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Miconazole Nitrate API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Miconazole Nitrate API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 22832-87-7 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Miconazole Nitrate API Manufacturer & Supplier in India

MEDIOCON INC is a trusted global manufacturer and supplier of Miconazole Nitrate API in India, offering high-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, formulation development, analytical testing, quality control, stability studies, and research applications. Our APIs are supplied with appropriate quality documentation to support pharmaceutical development, manufacturing, and quality-assurance requirements.

Miconazole Nitrate is a broad-spectrum imidazole antifungal active pharmaceutical ingredient used in pharmaceutical formulations for the treatment of a variety of fungal and yeast infections. It acts primarily by inhibiting the fungal cytochrome P450-dependent enzyme 14-alpha-demethylase, interfering with ergosterol biosynthesis and disrupting the fungal cell membrane. Miconazole Nitrate is used in topical and other pharmaceutical formulations for infections caused by susceptible fungi and yeasts. (dailymed.nlm.nih.gov)

Miconazole Nitrate is the nitrate salt of miconazole and has the molecular formula C₁₈H₁₄Cl₄N₂O·HNO₃, molecular weight approximately 479.15 g/mol, and CAS Number 22832-87-7. It is described as a white or almost white crystalline powder and is practically insoluble in water. 

MEDIOCON INC supplies premium-quality Miconazole Nitrate API to pharmaceutical manufacturers, contract manufacturing organizations (CMOs), contract research organizations (CROs), formulation companies, biotechnology companies, universities, research institutes, and analytical laboratories worldwide, supported with comprehensive documentation including COA, MSDS, technical data sheets, product specifications, analytical documentation, and applicable quality documents.

Product Specifications

Product NameMiconazole Nitrate API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number22832-87-7
CategoryActive Pharmaceutical Ingredient
GradeIP / BP / EP / USP
AppearanceWhite or Almost White Crystalline Powder
StandardsIP / BP / EP / USP Compliant

Analytical Specifications

ParameterSpecification
AppearanceWhite or Almost White Crystalline Powder
IdentificationIR / HPLC / Nitrate Complies
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 0.50%
Residue on IgnitionNMT 0.20%
Heavy MetalsNMT 20 ppm
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.00%
Water ContentNMT 0.50%
Melting Point178°C – 184°C
SolubilityPractically insoluble in water; soluble in organic solvents such as ethanol and methanol

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Miconazole Nitrate API Manufacturer & Supplier in India | MEDIOCON INC (CAS 22832-87-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Miconazole Nitrate API Manufacturer & Supplier in India | MEDIOCON INC is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing before release with a Certificate of Analysis.

Export Markets

  • USA — FDA-registered facility; DMF support available for ANDA/NDA filings
  • Europe — EMA-compliant documentation; CEP/EDMF support on request
  • Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
  • Southeast Asia — established logistics network; temperature-controlled shipments
  • India domestic — schedule H/X compliance; all state licensing documentation provided

Quality & Compliance

  • ISO 9001:2015 certified quality management system
  • GMP-certified manufacturing facility, Aurangabad, Maharashtra
  • Full batch traceability from raw material to finished API
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Miconazole Nitrate API Manufacturer & Supplier in India | MEDIOCON INC

What is Miconazole Nitrate API?
Miconazole Nitrate API is a broad-spectrum imidazole antifungal active pharmaceutical ingredient that inhibits fungal ergosterol biosynthesis and is used in pharmaceutical formulations for susceptible fungal and yeast infections.
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