Mirodenafil API Manufacturer in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Mirodenafil API

Mirodenafil, also known as SK-3530, is an orally active phosphodiesterase type 5 (PDE5) inhibitor. It inhibits PDE5, an enzyme involved in the degradation of cyclic guanosine monophosphate (cGMP), and is associated with the treatment of erectile dysfunction.

Mirodenafil is a synthetic small-molecule pharmaceutical compound belonging to the pyrrolopyrimidinone chemical class.

Mirodenafil API Manufacturer in India

Mirodenafil is a specialized PDE5 inhibitor API used in pharmaceutical research and formulation development. Quality control should address identity, assay, related substances, residual solvents, water content and other applicable pharmaceutical parameters.

Chemical Information

CAS Number: 862189-95-5
Molecular Formula: C26H37N5O5S
Molecular Weight: 531.67 g/mol
Synonyms: Mirodenafil, SK-3530, SK3530
Drug Class: PDE5 Inhibitor
Therapeutic Class: Erectile Dysfunction Treatment
Therapeutic Area: Urology / Sexual Health
Molecule Type: Synthetic Small Molecule
Stereochemistry: Achiral; no defined stereocenters

Mechanism of Action

Mirodenafil selectively inhibits phosphodiesterase type 5 (PDE5). PDE5 inhibition increases intracellular cGMP signaling, which contributes to smooth-muscle relaxation and vasodilation under appropriate physiological conditions.

Pharmaceutical Applications

Mirodenafil is associated with:

  • Erectile dysfunction
  • PDE5 inhibitor research
  • Urological pharmaceutical development
  • Vasodilator research
  • cGMP signaling research
  • Sexual-health pharmaceutical formulations

Mirodenafil Dihydrochloride

Mirodenafil is also encountered as mirodenafil dihydrochloride, CAS 862189-96-6. Its molecular formula is C26H37N5O5S·2HCl and molecular weight is 604.59 g/mol. Commercial analytical material is reported with an assay of ≥98% by HPLC.

Physical Characteristics

Mirodenafil free base has a molecular weight of 531.67 g/mol and is reported as achiral.

For the dihydrochloride form, commercial reference material is described as a powder/crystalline solid. Sigma-Aldrich reports ≥98% HPLC assay for its analytical material.

Quality Control Testing

Typical Mirodenafil API testing may include:

  • Identification by IR
  • HPLC identification
  • Assay by HPLC
  • Related substances
  • Residual solvents
  • Water content
  • Elemental impurities
  • Melting point
  • Stability testing

Detailed Specifications

Parameter Specification
Appearance White crystalline powder or crystals
Identification IR & HPLC compliant
Assay (HPLC) NLT 98.0% by HPLC
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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