Sildenafil Citrate

Sildenafil Citrate

Tham số Thông số kỹ thuật
Tên sản phẩm Sildenafil Citrate
Số CAS 171599-83-0
Công thức phân tử C22H30N6O4S · C6H8O7
Trọng lượng phân tử 666.7 g/mol
Hình thức Bột tinh thể màu trắng đến trắng ngà
Phương pháp phân tích (HPLC) 98.0% – 102.0% (on dried basis)
Độ hòa tan Sparingly soluble in water; soluble in methanol and DMSO
Gói 25 kg fiber drum with double polyethylene liners

Sildenafil Citrate Structure

Từ đồng nghĩa: 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.

Nguồn gốc và tiêu chuẩn hóa

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

Quality Specifications (QC Tests)

Test Item Thông số kỹ thuật
Xác định IR and HPLC retention time match reference standard
Mất mát khi sấy khô ≤ 0,5%
Hàm lượng tro sau khi đốt ≤ 0,1%
Kim loại nặng ≤ 20 ppm
Organic Impurities Đáp ứng các yêu cầu của USP
Chất dung môi còn lại Meets ICH Q3C limits
Giới hạn vi sinh vật Total aerobic count ≤ 1000 CFU/g; absence of specified pathogens

Bulk Supply & Documentation

  • Công suất hàng tháng: 500 kg
  • Thời gian thực hiện: 3-5 business days (stock items)
  • Tài liệu hướng dẫn: COA, MSDS, TDS sẽ được cung cấp theo yêu cầu
  • Bao bì: 25 kg fiber drum with double polyethylene liners

Các câu hỏi thường gặp

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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