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Vardenafil Dihydrochloride (CAS Registry Number: 224789-15-5) represents a critical active pharmaceutical ingredient (API) belonging to the class of selective phosphodiesterase type 5 (PDE5) inhibitors. Formulated structurally as 2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonylphenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazin-4-one dihydrochloride monohydrate, this chemical compound offers enhanced aqueous solubility and rapid bio-absorption profiles compared to base structures.
Information Gain Highlight: Unlike standard free-base PDE5 inhibitors, the salt form (Dihydrochloride Monohydrate, CAS 224789-15-5) demonstrates superior dissolution kinetics in physiological pH ranges. Our factory utilizes a patented multi-stage crystallization process that precisely controls polymorphic transition, guaranteeing zero contamination from undesirable crystalline amorphous phases.
To support global pharmaceutical formulators, CDMO partners, and technical procurement officers, Gentolex maintains exhaustive quality metrics compliant with United States Pharmacopeia (USP), European Pharmacopoeia (Ph. Eur.), and Japanese Pharmacopoeia (JP) monographs.
| Parameter Parameter | Standard Specification | Testing Methodology | Compliance Grade |
|---|---|---|---|
| Chemical Name | Vardenafil Dihydrochloride Monohydrate | IUPAC Nomenclature | Pharma Grade |
| CAS Registry Number | 224789-15-5 (Trihydrate/Monohydrate Dihydrochloride) | CAS Database Verification | Global Standard |
| Molecular Formula | C23H32N6O4S · 2HCl · H2O | Mass Spectrometry (MS) | Validated |
| Molecular Weight | 579.54 g/mol | Calculated / HRMS | Precision |
| Assay Purity (Dried Basis) | 99.0% – 101.0% (Typically ≥ 99.6%) | HPLC Normalization (UV @ 245nm) | Ultra Pure |
| Single Known Impurity | ≤ 0.10% (ICH Q3A Compliant) | RP-HPLC / LC-MS/MS | cGMP Bound |
| Residual Solvents | Meets ICH Q3C Guidelines (Ethanol < 5000ppm) | Headspace GC-FID | Safe |
| Heavy Metals | ≤ 10 ppm total heavy metal content | ICP-MS | Strict Control |
The chemical synthesis of Vardenafil Dihydrochloride requires rigorous control over intermediate condensation reactions. The process begins with chlorosulfonation of ethoxybenzamide derivatives, followed by coupling with 1-ethylpiperazine. The resulting imidazotriazinone ring closure demands precise thermal regulation to avoid degradation products such as N-desethyl vardenafil or chlorophenyl impurities.
At Gentolex, our production teams employ advanced inline Process Analytical Technology (PAT) using real-time FT-IR spectroscopy and HPLC monitoring. This controls the formation of nitrosamine impurities—a vital requirement for EU and US FDA compliance. Every lot of CAS 224789-15-5 undergoes strict testing for potential genotoxic impurities (GTIs), guaranteeing levels well below safety thresholds.
Leveraging vast industrial infrastructure to deliver unmatched batch consistency, competitive economics, and continuous chemical supply security.
Our expansive production base houses multiple cGMP-compliant cleanrooms, high-capacity reactors (up to 10,000L capacity), and automated crystallization chambers, allowing seamless scale-up from multi-gram R&D to multi-ton commercial yields.
China leads the world in basic chemical precursor availability. By sourcing intermediate key building blocks domestically, Gentolex eliminates supply disruptions, mitigates geopolitical tariff spikes, and delivers cost-effective pricing to international clients.
Equipped with modern waste treatment complexes, solvent recovery systems, and zero-discharge water filtration, our facilities guarantee long-term operational sustainability without risks of environmental shutdown.
Empowering pharmaceutical manufacturers across North America, Europe, LATAM, and Africa with turnkey documentation and regional representative offices.
We provide full Drug Master File (DMF) packages, Certificates of Suitability (CEP), structural elucidation data (NMR, FT-IR, Mass, XRD), and validated analytical methods to fast-track your ANDA and MAA drug filings with authorities like the FDA and EMA.
To reduce cross-border lead times and provide on-the-ground technical consultation, Gentolex maintains dedicated regional offices and logistics nodes in Mexico and South Africa. This direct presence ensures streamlined customs clearance and real-time localized communication.
Vardenafil Dihydrochloride (CAS 224789-15-5) is widely processed into film-coated tablets (5mg, 10mg, 20mg). Its high thermodynamic stability ensures prolonged shelf-life without degradation during high-speed compression processing.
Due to its rapid solubility profile, formulators increasingly utilize Vardenafil Dihydrochloride in Orodispersible Thin Films (ODF). This sublingual platform delivers faster therapeutic onset by bypassing first-pass hepatic metabolism.
Gentolex supplies certified reference materials (CRMs) and bulk active batches for analytical testing labs, bioequivalence (BE) trial batches, and targeted research institutions worldwide.
The market for PDE5 inhibitors is undergoing significant evolution driven by patent expirations, growing acceptance of erectile dysfunction (ED) therapies, and expanding applications in pulmonary arterial hypertension (PAH). Modern procurement teams face dual demands: maintaining strict cost controls while complying with evolving global regulatory frameworks regarding organic impurities and nitrosamine risks.
Gentolex’s goal is to create opportunities connecting the world with better services and guaranteed products. Up to date, Gentolex Group has been serving customers from more than 10 countries, specially, representatives are established in Mexico and South Africa.
Our main services focus on supplying peptides APIs and Custom Peptides, FDF license out, Technical Support & Consultation, Product Line and Lab Setup, Sourcing & Supply Chain Solutions.
With an overall factory construction area of 250,000 square meters operating under international cGMP standards, Gentolex offers flexible, scalable, and cost-effective solutions for clients globally.
High-purity fine chemicals, API intermediates, and bulk synthetic compounds tailored for scale-up manufacturing.
Solid-phase and liquid-phase synthesis of research-grade and cGMP therapeutic peptides.
Finished Dosage Form (FDF) licensing out, analytical dossier validation, and streamlined single-point supply chain management.
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