Vardenafil Hydrochloride

Updated: 2026-09-15

Overview

Vardenafil Hydrochloride is the hydrochloride salt form of vardenafil, a selective inhibitor of phosphodiesterase type 5 (PDE5). It is clinically used to treat erectile dysfunction by enhancing blood flow to the genital area. The compound was developed as an alternative to sildenafil, with improved selectivity for PDE5. As a B2B pharmaceutical raw material, it is supplied in bulk quantities to manufacturers for tablet formulation. Its production requires strict adherence to Good Manufacturing Practices (GMP) due to its medical applications. The global demand for vardenafil APIs has grown steadily, driven by increased awareness of men's health issues.

Physical and Chemical Properties

The compound presents as a white crystalline powder with moderate solubility in water (4.7 mg/mL at 25°C) and better solubility in organic solvents like DMSO. Its molecular structure contains a piperazine moiety and a sulfonyl group, contributing to its PDE5 binding affinity. Thermal analysis shows decomposition above 194°C, requiring temperature-controlled storage. The hydrochloride salt form improves stability and bioavailability compared to the free base. pH-dependent solubility makes it suitable for oral administration where gastric absorption occurs effectively.

Main Applications

The primary use is in 5-20mg strength tablets for erectile dysfunction treatment, marketed under brand names like Levitra. It works by relaxing smooth muscles in the corpus cavernosum, facilitating erection when combined with sexual stimulation. Off-label applications include pulmonary arterial hypertension management, though sildenafil remains more common for this indication. Some compounding pharmacies use the API for customized dosage forms. Research continues into potential cardiovascular and neurological applications due to PDE5's role in cellular signaling pathways.

Safety and Storage

As a potent API, occupational exposure limits should be enforced during handling. Powder forms may cause respiratory irritation; use NIOSH-approved N95 masks in powder processing areas. Secondary containment is recommended for bulk storage. Stability studies indicate 24-month shelf life when stored in original sealed containers below 8°C with <60% relative humidity. Excursions up to 25°C are permitted for short durations. Incompatible with strong oxidizers and bases - store separately from these materials. Facilities should maintain controlled substance logs where required by local regulations.

B2B Procurement Guide

Reputable suppliers should provide: 1) Active Pharmaceutical Ingredient (API) DMF filings 2) HPLC purity certificates (>98.5%) 3) Residual solvent analysis 4) Microbial limits testing. Request batch-specific COAs and validate through third-party testing if necessary. For international shipments, confirm compliance with import regulations (e.g., FDA 801, EU Directive 2001/83/EC). Container options typically include 1kg aluminum foil bags with HDPE liners or 5-25kg fiber drums. Consider suppliers with ISO 13485 certification for medical device-grade applications. Payment terms commonly range from LC at sight to 30-day credit for established buyers.