Active Pharmaceutical Ingredient

Vardenafil

Also known as: Levitra; Staxyn; ZK 100440

CAS: 224785-91-5 PDE5 Inhibitor API IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Vardenafil API — Mediocon Inc
Vardenafil — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 224785-91-5  |  MF: C₂₃H₃₂N₆O₄S·3H₂O  |  MW: 579.63 g/mol

Vardenafil is a high-purity Active Pharmaceutical Ingredient supplied by Mediocon Inc conforming to IP / BP / EP / USP specifications. Manufactured at our GMP-certified facility in Aurangabad, Maharashtra, India.

Vardenafil is a selective phosphodiesterase type 5 (PDE5) inhibitor used in the treatment of erectile dysfunction (ED). By inhibiting PDE5, it prevents the breakdown of cyclic GMP in smooth muscle cells of the corpus cavernosum, promoting vasodilation and facilitating penile erection in response to sexual stimulation. It is also investigated for pulmonary arterial hypertension.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing facility

Applications

  • Erectile dysfunction (ED) treatment
  • Pulmonary arterial hypertension research
  • PDE5 inhibitor pharmaceutical formulations
  • Sexual dysfunction drug development

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 NameVardenafil
Also Known AsLevitra; Staxyn; ZK 100440
CAS Number224785-91-5
Molecular FormulaC₂₃H₃₂N₆O₄S·3H₂O
Molecular Weight579.63 g/mol
Chemical Name(2S)-2-[4-Ethoxy-3-[4-(2-pyrimidinyl)-1-piperazinyl]sulfonylphenyl]-1-methyl-5-propyl-7H-pyrrolo[2,3-d]pyrimidin-7-one trihydrate
CategoryPDE5 Inhibitor / Erectile Dysfunction Agent
AppearanceWhite to off-white crystalline powder
SolubilitySlightly soluble in water; soluble in methanol and DMSO
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch No.VDF/24033052
Mfg DateMAR 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement
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