Description

Vardenafil, Dihydrochloride Salt is the active pharmaceutical ingredient (API) used in the manufacture of prescription medications for the treatment of erectile dysfunction. This high-purity compound is critical for ensuring the efficacy, safety, and batch-to-batch consistency of the final pharmaceutical formulation. It is primarily required by pharmaceutical manufacturers and research institutions engaged in drug development and production.

Application

• Pharmaceutical Active Ingredient (API): Primary raw material for the formulation of prescription drugs targeting erectile dysfunction.
• Finished Dosage Form Manufacturing: Used in the production of tablets and other solid oral dosage forms under controlled GMP conditions.
• Pharmaceutical Research & Development (R&D): Serves as a reference standard and key intermediate in preclinical and clinical studies for new drug development.
• Analytical Reference Standard: Employed in quality control laboratories for method development, validation, and routine assay testing.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for the production of generic and branded medications.

Basic Information

Product Name	Vardenafil, Dihydrochloride Salt
CAS No.	224788-34-5
Molecular Formula	C23H32N6O4S · 2HCl
Molecular Weight	579.5 g/mol
Synonyms	Vardenafil HCl; Vardenafil Dihydrochloride; Levitra API; N-[2-Ethoxy-5-[(4-ethylpiperazin-1-yl)sulfonyl]phenyl]-3-methyl-7-propyl-1H-purine-2,6-dione dihydrochloride; 2-[2-Ethoxy-5-(4-ethylpiperazin-1-ylsulfonyl)phenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazin-4-one dihydrochloride; BA-38,190B
EINECS	Contact for details

Quality Control

Our Vardenafil, Dihydrochloride Salt is manufactured and tested under strict quality management systems. We provide material that meets or exceeds current pharmacopeial standards, including ICH Q7 GMP guidelines for active pharmaceutical ingredients. A comprehensive Certificate of Analysis (COA) is supplied with each batch, detailing purity, identity, and impurity profiles as determined by validated analytical methods such as HPLC, IR, and titration.

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 standard
Identification (HPLC)	Retention time matches reference
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Heavy Metals	≤ 20 ppm

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