Avanafil

Avanafil

Параметр Технические характеристики
Название продукта Avanafil
Номер CAS 330784-47-9
Молекулярная формула C23H26ClN7O3
Молекулярная масса 483.95 g/mol
Внешний вид Кристаллический порошок от белого до небелого цвета
Анализ (ВЭЖХ) ≥99,01 TP3T
Растворимость Soluble in DMSO, slightly soluble in ethanol, practically insoluble in water
Упаковка 25 kg net weight in fiber drums with double polyethylene liners

Avanafil Structure

Синонимы: TA-1790, 4-[(3-Chloro-4-methoxybenzyl)amino]-2-[(2S)-2-(hydroxymethyl)pyrrolidin-1-yl]-N-(pyrimidin-2-ylmethyl)pyrimidine-5-carboxamide, Avanafilum, Stendra, Spedra, TA 1790

Avanafil is a highly selective phosphodiesterase type 5 (PDE5) inhibitor developed for the treatment of erectile dysfunction. It is a synthetic small-molecule API manufactured under cGMP conditions, available as a white to off-white crystalline powder with an assay of ≥99.0% by HPLC.

Known commercially as Stendra and Spedra, Avanafil is distinguished by its rapid onset of action and high selectivity for PDE5 over other phosphodiesterase isoenzymes, which translates into a favorable side-effect profile. As a bulk API, it serves formulators developing oral solid dosage forms, including immediate-release tablets and orally disintegrating formulations.

Основные особенности продукта

  • High purity: ≥99.0% by HPLC, with tight control on related substances and residual solvents.
  • Selective PDE5 inhibition: High selectivity over PDE6 and PDE11, potentially reducing visual and musculoskeletal side effects.
  • Rapid onset: Peak plasma concentrations reached within 30–45 minutes in clinical studies.
  • Regulatory support: Full documentation package including COA, MSDS, TDS, and cGMP manufacturing statements.
  • Scalable supply: Commercial-scale production capacity to support both clinical and commercial needs.

Applications & Formulation Use

  • Oral tablets for erectile dysfunction, including immediate-release and orodispersible dosage forms.
  • Fixed-dose combination products requiring a fast-acting PDE5 inhibitor.
  • Reference standard and analytical method development.
  • Clinical research and bioequivalence studies.

Quality Specifications (QC Tests)

Test Item Технические характеристики
Идентификация IR and HPLC retention time conform to reference standard
Потери при сушке ≤0,51 TP3T
Остаток после прокаливания ≤0,11 TP3T
Тяжелые металлы ≤20 ppm
Органические примеси Any individual impurity ≤0.5%; total impurities ≤1.0%
Microbial Limits Total aerobic count ≤1000 CFU/g; yeast and mold ≤100 CFU/g; absence of E. coli and Salmonella

Bulk Supply & Ordering

  • Packaging: 25 kg fiber drums with double polyethylene liners, or as per customer request.
  • MOQ: 1 kg for stock items; 25 kg for custom packaging.
  • Срок выполнения заказа: 3-5 business days for stock items.
  • Documentation: COA, MSDS, TDS, and cGMP statement provided with each shipment.

Frequently Asked Questions

What is the minimum order quantity (MOQ) for Avanafil?

Our standard MOQ is 1 kg for stock items. For custom packaging or larger quantities, the MOQ is 25 kg. We can accommodate smaller quantities for research and development upon request.

What is the delivery time?

For stock items, the lead time is 3-5 business days from order confirmation. We ship globally via express couriers and air freight.

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

Yes, a COA is provided with every shipment. Samples for analytical evaluation are available upon request; sample dispatch typically takes 1-2 days after approval.

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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