Description

Mirodenafil CAS NO 862189-95-5 is a selective phosphodiesterase type 5 (PDE5) inhibitor, a high-purity active pharmaceutical ingredient (API) of significant commercial and therapeutic importance. It is valued for its specific pharmacological activity and is a critical component in the development and manufacturing of pharmaceutical formulations. This compound is primarily required by pharmaceutical companies, research institutions, and contract development and manufacturing organizations (CDMOs) engaged in the production of therapeutic agents.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of finished dosage forms for the treatment of erectile dysfunction.
• Research & Development: Used in preclinical and clinical studies to investigate pharmacokinetics, pharmacodynamics, and therapeutic efficacy.
• Reference Standard: Serves as a high-purity analytical standard for quality control and method validation in laboratory testing.
• Formulation Development: Utilized in the development of various drug delivery systems, including tablets and other solid oral dosage forms.
• Contract Manufacturing: Supplied to CDMOs for the commercial-scale production of generic or branded pharmaceutical products.
• Biochemical Research: A tool compound for studying PDE5 enzyme inhibition and related signal transduction pathways in cellular and molecular biology.

Basic Information

Product Name	Mirodenafil
CAS No.	862189-95-5
Molecular Formula	C22H30N6O4S
Molecular Weight	474.58 g/mol
Synonyms	SK-3530; Mirodenafilum; 5-[2-Ethoxy-5-[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one; SK3530; DA 8159
EINECS	Contact for details

Quality Control

Our Mirodenafil is manufactured under strict quality management systems. Every batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, consistent with ICH guidelines. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with agreed-upon standards. We support our clients' regulatory submissions with comprehensive documentation.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment to maintain stability and purity. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm
Loss on Drying	≤ 1.0%
Residue on Ignition	≤ 0.1%
Microbial Limits	Complies with Ph. Eur. 2.6.12/2.6.13

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.