Description

Mirodenafil Dihydrochloride CAS NO 862189-96-6 is a high-purity pharmaceutical active ingredient, specifically a selective phosphodiesterase type 5 (PDE5) inhibitor. This compound is critical for the development and manufacturing of therapeutic agents targeting erectile dysfunction, offering a distinct pharmacological profile. It is primarily required by pharmaceutical R&D laboratories, formulation scientists, and contract manufacturing organizations (CMOs) engaged in the production of innovative and generic medications.

Application

• Pharmaceutical Active Ingredient (API): Core component in the formulation of prescription medications for erectile dysfunction.
• Reference Standard: Used in analytical laboratories for method development, validation, and quality control testing of finished drug products.
• Research & Development: Serves as a key intermediate or target molecule in preclinical and clinical studies for urological and cardiovascular research.
• Generic Drug Manufacturing: Essential for companies producing bioequivalent versions of branded PDE5 inhibitor drugs.
• Formulation Development: Used in creating various dosage forms such as tablets, orally disintegrating films, or other novel delivery systems.

Basic Information

Product Name	Mirodenafil Dihydrochloride
CAS No.	862189-96-6
Molecular Formula	C₂₃H₃₃Cl₂N₇O₃S
Molecular Weight	582.52 g/mol
Synonyms	Mirodenafil HCl; SK3530; 5-Ethyl-2-{5-[4-(2-hydroxyethyl)piperazin-1-ylsulfonyl]-2-propoxyphenyl}-7-propyl-3,5-dihydro-4H-pyrrolo[3,2-d]pyrimidin-4-one dihydrochloride; SK-3530; Mirodenafil Dihydrochloride Hydrate (if applicable)
EINECS	Contact for details

Quality Control

Our Mirodenafil Dihydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines. A detailed Certificate of Analysis (COA) providing results for assay, related substances, residual solvents, and other critical parameters is supplied with every shipment to guarantee traceability and compliance.

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 under dry, inert conditions to maintain stability and prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Total impurities ≤ 1.0%; Any single impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C
Heavy Metals	≤ 20 ppm

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