Explore our high-purity synthesized catalog supporting global pharmaceutical development and enterprise sourcing.
A comprehensive technical evaluation of molecular properties, synthesis standards, regulatory compliance, and industrial OEM capability.
Sildenafil Citrate (CAS Registry Number: 171599-83-0) represents a vital active pharmaceutical ingredient (API) widely utilized in the formulation of therapeutic treatments for erectile dysfunction (ED) and pulmonary arterial hypertension (PAH). As a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), this small molecule derivative plays an essential role in modulating smooth muscle relaxation and local vasodilation.
For global pharmaceutical brands, generic drug producers, and contract manufacturing organizations (CMOs), sourcing high-grade, batch-consistent OEM Sildenafil Citrate is a critical determinant of final dosage form (FDF) efficacy, bioavailability, and stability profile. Gentolex Group operates a state-of-the-art chemical manufacturing infrastructure engineered to meet stringent ICH Q7, cGMP, and international pharmacopeial standards (USP, EP, JP).
| Chemical Property | Technical Specification Standard |
|---|---|
| IUPAC Name | 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate |
| CAS Number | 171599-83-0 |
| Molecular Formula | C22H30N6O4S · C6H8O7 |
| Molecular Weight | 666.70 g/mol |
| Appearance | White to off-white crystalline powder |
| Assay (HPLC) | 98.0% – 102.0% (Anhydrous Basis) |
| Particle Size Distribution | Customizable Micronization (e.g., D90 < 20 μm, D50 < 5 μm) |
| Related Impurities | Impurity A, B, C, D strictly ≤ 0.10% (ICH Q3A Guidelines) |
| Heavy Metals & Solvents | Heavy Metals ≤ 10 ppm; Residual Solvents compliant with ICH Q3C |
Maximizing procurement security through backward integration, raw material availability, and localized market response.
China accounts for a substantial proportion of global key starting materials (KSMs) and intermediate synthesis. Our direct integration with precursor production lines guarantees steady, uninterrupted raw material supply, bypassing global market volatility.
We provide full Drug Master File (DMF) packages, Certificate of Analysis (CoA), stability study data under ICH Q1A-Q1E conditions, and audit support for health authority submissions across FDA, EMA, and PMDA jurisdictions.
With active regional customer support and distribution infrastructure in key markets like Mexico and South Africa, Gentolex bridges international supply chain delays, facilitating seamless customs handling and localized warehouse delivery.
Custom micronization and polymorph control to suit varied final oral dosage formats.
The standard therapeutic approach requires rapid disintegration and consistent dissolution rates. OEM Sildenafil Citrate manufactured by Gentolex undergoes strict particle size distribution (PSD) optimization, enabling high direct compression efficiency and uniform blend homogeneity in high-speed tablet presses.
Modern pharmaceutical consumer demands prioritize fast-acting and waterless delivery systems. Micronized OEM Sildenafil Citrate (D90 < 10 µm) provides optimal dissolution profiles necessary for rapid sublingual or buccal absorption formulations, reducing first-pass metabolic delay.
In pediatric or low-dosage PAH treatments, precise dosing accuracy is mandatory. Our API undergoes tight crystalline polymorphism control (Form I stability), ensuring physical stability against ostwald ripening when formulated in oral liquids.
Dual-action therapies require rigorous excipient compatibility studies. Gentolex offers custom impurity-screened API batches that prevent unwanted chemical interaction with SSRIs or secondary active agents during dry or wet granulation processing.
Connecting global pharmaceutical enterprises with world-class API synthesis, lab setup, and contract development services.
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.
An overall factory construction area of 250,000 square meters under international standard allows Gentolex to offer flexible, scalable, and cost-effective solutions for global contract procurement. Gentolex offers an extensive range of APIs and intermediates for development study and commercial application with cGMP standard from long-term collaborations. Documents and Certificates are supported to customers worldwide.
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