Active Pharmaceutical Ingredient

Sertaconazole Nitrate — CAS 709031-78-7

Also known as: Ertaczo / Zalain Active

GMP Certified IP / BP / EP / USP Antifungal / Imidazole Salt Aurangabad, India
Sertaconazole Nitrate API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Sertaconazole Nitrate IP / BP / EP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 709031-78-7

Product Overview

Sertaconazole Nitrate is the nitrate salt form of the imidazole antifungal Sertaconazole, commonly marketed as Ertaczo and Zalain. It provides enhanced stability and bioavailability for topical formulations targeting dermatophytes and Candida species. Its dual mechanism — ergosterol synthesis inhibition and membrane disruption — provides broad antifungal coverage. Mediocon Inc manufactures pharmacopoeial-grade Sertaconazole Nitrate API at its GMP facility.

Therapeutic Applications
  • Tinea pedis, corporis, cruris
  • Cutaneous candidiasis
  • Seborrheic dermatitis
  • Topical cream/gel formulations

Technical Specifications

ParameterSpecification
CAS Number709031-78-7
Molecular FormulaC₂₀H₁₅Cl₃N₂OS·HNO₃
Molecular Weight500.78 g/mol
GradeIP / BP / EP / USP
CategoryAntifungal / Imidazole Salt
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Mfg DateMAR 2025
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / EP / USP standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support
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