Sildenafil Citrate

Sildenafil Citrate

Parámetro Especificaciones
Nombre del producto Sildenafil Citrate
Número CAS 171599-83-0
Fórmula molecular C22H30N6O4S · C6H8O7
Peso molecular 666.7 g/mol
Apariencia Polvo cristalino de color blanco a blanquecino
Ensayo (HPLC) 98.0% – 102.0% (on dried basis)
Solubilidad Sparingly soluble in water; soluble in methanol and DMSO
Paquete 25 kg fiber drum with double polyethylene liners

Sildenafil Citrate Structure

Sinónimos: Sildenafil citrate, 171599-83-0, Viagra, Revatio, UK-92480-10, 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

Sildenafil citrate is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), developed by Pfizer for the treatment of erectile dysfunction and pulmonary arterial hypertension. It is a white to off-white crystalline powder, freely soluble in methanol and DMSO, and practically insoluble in water. The citrate salt form enhances aqueous solubility and stability, making it suitable for oral solid dosage forms.

Since its approval in 1998, sildenafil citrate has become a standard therapy in both erectile dysfunction and pulmonary arterial hypertension. Its mechanism involves potentiation of nitric oxide (NO)-mediated vasodilation by inhibiting PDE5, thereby increasing cGMP levels and promoting smooth muscle relaxation. The compound is well characterized, with extensive clinical and commercial history, and is widely used in generic and branded products globally.

As a B2B supplier, LyvBio offers sildenafil citrate with high purity and consistent quality, supported by comprehensive documentation. Our material is manufactured under cGMP conditions and is suitable for formulation into tablets, oral suspensions, and other dosage forms. We serve pharmaceutical manufacturers, compounding pharmacies, and research institutions worldwide.

Function & Mechanism

  • PDE5 inhibition: Selectively inhibits cGMP-specific phosphodiesterase type 5, increasing cGMP levels in smooth muscle cells.
  • Vasodilation: Enhances nitric oxide-mediated relaxation of corpus cavernosum and pulmonary vascular smooth muscle.
  • Erectile dysfunction treatment: Improves erectile function by increasing blood flow to the penis during sexual stimulation.
  • Pulmonary arterial hypertension: Reduces pulmonary arterial pressure and improves exercise capacity in PAH patients.
  • Rapid onset: Onset of action typically within 30–60 minutes after oral administration.

Source & Standardization

  • Source: Synthetic chemical synthesis.
  • Manufacturing: Produced under cGMP conditions with strict control of impurities and residual solvents.
  • Standardization: Complies with USP monograph for Sildenafil Citrate.
  • Forms: White to off-white crystalline powder.
  • Aplicaciones: Pharmaceutical tablets, oral suspensions, and research formulations.

Quality Specifications (QC Tests)

Test Item Especificaciones
Identificación IR and HPLC retention time match reference standard
Pérdida por secado ≤ 0,51 TP3T
Residuo tras la combustión ≤ 0,11 TP3T
Metales pesados ≤ 20 ppm
Organic Impurities Meets USP requirements
Disolventes residuales Meets ICH Q3C limits
Límites microbianos Total aerobic count ≤ 1000 CFU/g; absence of specified pathogens

Bulk Supply & Documentation

  • Monthly capacity: 500 kg
  • Plazo de entrega: 3-5 días laborables (artículos en stock)
  • Documentación: Certificado de análisis (COA), ficha de datos de seguridad (MSDS) y ficha técnica del producto (TDS) disponibles previa solicitud
  • Embalaje: 25 kg fiber drum with double polyethylene liners

Preguntas frecuentes

What is the minimum order quantity (MOQ)?

Our MOQ for sildenafil citrate is 1 kg. For larger quantities, please contact our sales team for a quotation.

What is the delivery time?

For stock items, delivery time is 3-5 business days after order confirmation.

Do you provide a Certificate of Analysis (COA) and samples?

Yes, we provide a COA for each batch. Samples are available upon request; please contact us for details.

Contact & Ordering Information

  • Company: LyvBio Co., Ltd.
  • Address: Room 5-0203, Courtyard 205, Lianhu District, Xi’an, Shaanxi, China
  • Email: info@lyvbio.com
  • Phone: +86-29-65816888

send us your specification for a quotation.

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Room,5-0203, Unit 5, Beiyuanmen Street,Xi'an,Shaanxi,China

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