Introduction
Vardenafil Hydrochloride (HCl) powder is a pharmaceutical-grade raw material classified as a PDE5 inhibitor, primarily used for the treatment of erectile dysfunction (ED). In its pure API form, Vardenafil powder serves as the foundation for Levitra® and Staxyn® generics, as well as research-grade formulations for labs and CROs.
Since patent expirations, generic Vardenafil powder is widely available from China, India, and regulated markets, making it an important compound for pharma manufacturers, wholesalers, and research organizations.
👉 For procurement strategy, see the Complete 2025 Buyer’s Guide to Vardenafil HCl Powder.
Chemical Identity & Properties
- Name: Vardenafil Hydrochloride
- CAS Number: 224785-90-4
- Molecular Formula: C23H32N6O4S·HCl
- Molecular Weight: ~579.1 g/mol
- Appearance: White to pale yellow crystalline powder
- Solubility: Freely soluble in methanol/ethanol; sparingly soluble in water
- Stability: Stable for 24–36 months under 2–8°C storage conditions
Mechanism of Action
Vardenafil belongs to the phosphodiesterase type 5 (PDE5) inhibitor class, alongside Sildenafil (Viagra®) and Tadalafil (Cialis®).
- How it works:
- Inhibits PDE5 enzyme in penile tissue.
- Prevents breakdown of cGMP (cyclic guanosine monophosphate).
- Results in smooth muscle relaxation and increased blood flow.
- Clinical outcome: Improved erection firmness and duration during sexual stimulation.
Selectivity:
- Vardenafil is more selective for PDE5 than Sildenafil, reducing off-target side effects (e.g., visual disturbances from PDE6 inhibition).
👉 For comparative analysis, see Vardenafil vs Other PDE5 Inhibitors.
Pharmaceutical Applications
- Erectile Dysfunction (ED)
- Approved worldwide in 10–20 mg tablet form.
- Marketed as Levitra® and Staxyn®.
- Generic formulations produced using bulk Vardenafil powder.
- Pulmonary Arterial Hypertension (PAH) (research/off-label)
- PDE5 inhibitors studied for reducing pulmonary blood pressure.
- Limited clinical adoption for Vardenafil compared to Sildenafil.
- Compounding Pharmacies
- Vardenafil powder is used to create customized dosages for patient-specific needs.
- Formulation Development
- Used in research for orally disintegrating tablets (ODTs) and oral thin films.
👉 For sourcing bulk lots, see Wholesale Vardenafil Powder Supply Guide.
USP & Quality Standards
Vardenafil powder must meet pharmacopeial specifications before use in pharmaceutical formulations.
USP/EP Standards:
- Purity: ≥99% (HPLC)
- Residual Solvents: Within ICH Q3C guidelines
- Heavy Metals: ≤10 ppm
- Assay: Matches USP reference standard
Documents Required:
- COA (Certificate of Analysis)
- MSDS (Material Safety Data Sheet)
- GMP Certificate
- DMF/CEP (if targeting FDA/EMA-regulated markets)
👉 For QC methods, see How to Check Vardenafil Powder Quality: USP Standards & COA.
Market & Research Outlook (2025)
- ED Market Growth: Aging populations drive increasing demand for PDE5 inhibitors.
- Generic Expansion: Post-patent expiry, China and India dominate supply.
- Research Applications: Ongoing trials for new dosage forms and combination therapies.
- Forecast: PDE5 inhibitor API market projected to grow steadily, with Vardenafil maintaining a niche role.
Conclusion
Vardenafil Hydrochloride powder is a potent PDE5 inhibitor API used in ED treatments, compounding, and research. Its short half-life (~4–5 hours), high selectivity, and established safety profile make it a valuable option in the PDE5 inhibitor family.
Key takeaways:
- Supplied as USP-grade powder for pharma manufacturing.
- Requires ≥99% HPLC purity, GMP, and MSDS documentation.
- Used for ED formulations, R&D, and custom compounding.
- Sourced mainly from China (low cost) and India (compliance-driven plants).
📌 Next Steps for Buyers:
- Direct sourcing
- Bulk scaling
- Factory vetting
→ Buy Vardenafil Powder Online
By combining technical validation with supplier due diligence, buyers can ensure their Vardenafil sourcing is safe, compliant, and cost-efficient.