Introduction
Research-grade Vardenafil Hydrochloride (HCl) powder is supplied as RUO (Research Use Only) material in 100 g–1 kg lots for preclinical studies, formulation development, PK/PD modeling, and comparator trials. While GMP/USP lots are used to manufacture finished medicines, RUO material accelerates screening and feasibility work at significantly lower upfront cost and with faster lead times.
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What Makes Vardenafil Useful for Research
- Mechanism: Potent PDE5 inhibitor that increases cGMP → smooth muscle relaxation → enhanced blood flow.
- Selectivity: More PDE5-selective than some first-generation agents, useful for off-target profiling (e.g., PDE6).
- PK Profile: Rapid onset with ~4–5 h half-life, enabling acute models and quicker washout vs long-acting comparators.
- Formulation Friendly: Soluble in organic solvents; supports ODT, film, nanosuspension, and lipid-based explorations.
Core Research Applications
1) Sexual Medicine / ED Models
- Efficacy screens in animal models to map dose–response on erectile function.
- Comparator trials against other PDE5 inhibitors to quantify onset, duration, and selectivity trade-offs.
- Patient-centric formats: Preformulation data for fast-dissolving oral films and ODTs for ease of use.
2) Pulmonary Arterial Hypertension (PAH) Investigations
- PDE5 inhibition is relevant to pulmonary vasodilation; Vardenafil serves as an alternative probe compound in PAH pathways and vascular tone studies.
3) Combination Therapy Studies
- ED + PE or ED + metabolic comorbidities: Explore synergy with agents that modulate serotonergic, nitric-oxide, or endothelial pathways.
- Pharmacodynamic stacking with lifestyle or nutraceutical adjuncts in preclinical settings (mechanistic only; not clinical advice).
4) PK/PD & Bioavailability Work
- In-vitro dissolution (USP apparatus II/IV), in-situ perfusion, and small animal PK for absorption and metabolism insights.
- BCS-oriented excipient screening to improve dissolution and first-pass outcomes.
5) Novel Dosage Forms & Delivery Systems
- Orally disintegrating tablets (ODTs), thin films, sprinkle capsules, nanosuspensions, and lipidic carriers to optimize onset and patient adherence.
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Research-Grade vs GMP-Grade: What’s the Difference?
| Attribute | Research-Grade (RUO) | GMP/USP API (Commercial) |
|---|---|---|
| Intended Use | In-vitro, preclinical, method development | Human drug manufacturing |
| Typical Purity | ≥98–99% (analytical spec) | ≥99% (USP/EP compliant) |
| Lot Size | 100 g–1 kg (sometimes 5 kg) | 25–100 kg drums |
| Documentation | COA, MSDS | COA, MSDS, GMP, DMF/CEP |
| Release Testing | Analytical identity & assay | Full pharmacopeial panel + validation |
| Labeling | For Research Use Only | API for human use (regulated) |
⚠️ Always keep RUO and GMP supply chains separate in your QMS to avoid cross-designation risk.
Safety, Handling & Storage (Lab SOP Snapshot)
- PPE: Gloves, goggles, lab coat; respirator for powder handling.
- Controls: Handle in fume hood; minimize dust/aerosolization.
- Storage: 2–8 °C, double-sealed foil pouches in fiber drums; protect from light and humidity.
- Waste: Collect residues/filters as hazardous chemical waste per local law.
👉 Full details in Vardenafil MSDS & Safety Guidelines.
Sourcing & Pricing for Research Programs
Lot Sizes & Packaging
- 100 g / 250 g / 500 g / 1 kg RUO packs; vacuum-sealed foil with desiccant; outer HDPE or mini-drum.
- Labeling: CAS, batch/lot, manufacture date, storage, hazards.
2025 Pricing Benchmarks (RUO)
- China RUO small lots (100 g–1 kg): $650–$900/kg equivalent.
- India RUO small lots: $700–$950/kg equivalent (often higher compliance docs).
- US/EU distributors (1–5 kg research): $1,000–$1,400/kg.
(RUO typically carries a premium per kilo vs large GMP drums because of small-pack overhead, analytical release, and local distribution markups.)
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Buyer’s Mini-Checklist (Labs & CROs)
- Documents: Batch-specific COA + MSDS (even for RUO).
- Analytical: Request chromatograms; verify identity/purity with HPLC, consider NMR/IR confirmation for critical work.
- Specs: Clarify particle size (micronized vs non-micronized) for dissolution studies.
- Stability: Ask for accelerated/real-time data if your project spans many months.
- Chain of Custody: Record batch IDs in ELN/LIMS; keep RUO segregated from GMP areas.
- Scale Path: Plan the transition from RUO → GMP/USP lots to avoid reformulation shocks.
Common Pitfalls & How to Avoid Them
- Assuming RUO = GMP: Maintain clear boundaries; RUO is not for human use.
- Skipping third-party tests: Always spot-check identity/purity, especially from new vendors.
- Ignoring packaging quality: Single-bag or unsealed packs raise contamination and stability risks.
- Chasing the lowest quote: Sub-$280/kg “bulk” claims typically signal counterfeit or adulterated materials.
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Example Research Workstreams You Can Run Next Quarter
- Rapid onset optimization: Compare ODT vs film vs capsule in dissolution + rat PK.
- Selectivity profiling: PDE panel to benchmark off-target PDE6 activity vs sildenafil.
- Nanosuspension pilot: Wet-milling parameters → z-avg sizing → in-vitro flux.
- Stability mapping: ICH accelerated conditions (e.g., 40 °C/75% RH) to rank excipient sets.
Conclusion
Research-grade Vardenafil HCl powder gives labs and CROs a nimble tool for sexual medicine, vascular pharmacology, and advanced formulation studies. With acute PK, solid selectivity, and broad formulation compatibility, it’s ideal for screening and prototyping before locking a commercial path.
Where to go from here:
- Order RUO packs
- Plan scale-up
- Confirm supplier quality
- Ensure safety & docs