Description

Vardenafil Dihydrochloride is a high-purity active pharmaceutical ingredient (API) and a potent, selective inhibitor of phosphodiesterase type 5 (PDE5). It is a critical compound for the development and manufacturing of pharmaceutical formulations targeting erectile dysfunction. This API is essential for pharmaceutical companies, research institutions, and contract manufacturing organizations (CMOs) engaged in the production of generic and branded medications.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of finished dosage forms for the treatment of erectile dysfunction.
• Generic Drug Formulation: Used in the development and production of generic versions of PDE5 inhibitor medications.
• Clinical Research Material: Serves as a reference standard and raw material in preclinical and clinical studies.
• Analytical Reference Standard: Utilized in quality control laboratories for method development, validation, and routine testing via HPLC, LC-MS, etc.
• Contract Manufacturing: Supplied to CMOs for toll manufacturing and custom synthesis projects.
• Biochemical Research: Used in pharmacological studies to investigate PDE5 enzyme inhibition and related cardiovascular pathways.

Basic Information

Product Name	Vardenafil Dihydrochloride
CAS No.	224789-15-5
Molecular Formula	C23H33ClN6O4S • 2HCl
Molecular Weight	579.0 g/mol (for dihydrochloride salt)
Synonyms	Vardenafil HCl; Vardenafil Hydrochloride; 2-[2-Ethoxy-5-[(4-ethylpiperazin-1-yl)sulfonyl]phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one dihydrochloride; Levitra (Brand Name API); Nuviva
EINECS	Contact for details

Quality Control

Our Vardenafil 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.

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 potency.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Residual Solvents (GC)	Complies with ICH Q3C

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