Description

Vardenafil Hydrochloride is a high-purity active pharmaceutical ingredient (API) primarily used in the treatment of erectile dysfunction. Its quality and consistency are critical for ensuring the safety and efficacy of the final pharmaceutical formulation. This compound is essential for manufacturers in the global pharmaceutical industry, particularly those producing generic and branded medications. We supply this API to meet the stringent demands of research, development, and commercial production.

Application

• Pharmaceutical API: Primary active ingredient in the manufacture of oral tablets for the treatment of erectile dysfunction.
• Generic Drug Production: Sourcing for cost-effective generic versions of branded medications.
• Research & Development: Used in preclinical and clinical studies for new drug formulations and delivery systems.
• Reference Standard: Serves as a high-purity standard for analytical testing and quality control in laboratories.
• Contract Manufacturing: Supplied to CDMOs (Contract Development and Manufacturing Organizations) for finished dosage form production.

Basic Information

Product Name	Vardenafil Hydrochloride
CAS No.	224785-91-5
Molecular Formula	C23H33ClN6O4S • HCl
Molecular Weight	579.0 g/mol
Synonyms	Vardenafil HCl; 2-[2-Ethoxy-5-[(4-ethylpiperazin-1-yl)sulfonyl]phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4(3H)-one hydrochloride; Levitra (Brand Name API); Nuviva (Brand Name API); (3S,5R)-Vardenafil Hydrochloride; Vardenafil Monohydrochloride; BA-21038
EINECS	Contact for details

Quality Control

Our Vardenafil Hydrochloride is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for assay and impurity profiling, to ensure it meets pharmaceutical-grade specifications and relevant pharmacopeial standards (e.g., USP, EP). A detailed Certificate of Analysis (COA) is provided with every shipment to guarantee purity, identity, 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 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)	Conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.5%
Specific Rotation	Contact for details

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