Тадалафил

Тадалафил

Параметр Технические характеристики
Название продукта Тадалафил
Другие названия IC351, GF196960
Номер CAS 171596-29-5
Молекулярная формула C22H19N3O4
Молекулярная масса 389.4 g/mol
Внешний вид Кристаллический порошок от белого до небелого цвета
Анализ (ВЭЖХ) ≥99,01 TP3T
Растворимость Sparingly soluble in DMSO, practically insoluble in water
Упаковка 25 kg fiber drum, double polyethylene bags inside

Tadalafil Structure

Синонимы: Tadalafil, 171596-29-5, IC351, GF196960, (6R,12aR)-6-(1,3-Benzodioxol-5-yl)-2-methyl-2,3,6,7,12,12a-hexahydropyrazino[1′,2′:1,6]pyrido[3,4-b]indole-1,4-dione

Tadalafil is a synthetic phosphodiesterase type 5 (PDE5) inhibitor developed for the treatment of erectile dysfunction and pulmonary arterial hypertension. It is a chiral, white to off-white crystalline powder with a molecular formula of C22H19N3O4 and a molecular weight of 389.4 g/mol. Unlike other PDE5 inhibitors, tadalafil has a longer half-life and a broader tissue distribution, making it a preferred choice for both on-demand and chronic therapy.

Chemically, tadalafil belongs to the pyrazino[1′,2′:1,6]pyrido[3,4-b]indole class. Its structure features a methylenedioxyphenyl group and a piperazinedione core, which confer high selectivity for PDE5 over other phosphodiesterases. This selectivity underpins its efficacy and favorable side-effect profile. The compound is practically insoluble in water but soluble in organic solvents such as DMSO and dimethylformamide.

Manufactured under cGMP conditions, tadalafil is available at high purity (≥99.0% by HPLC). It is primarily supplied to pharmaceutical companies for the production of finished dosage forms, including tablets for erectile dysfunction and pulmonary arterial hypertension. Our material is routinely tested for identity, assay, and impurities to meet global pharmacopeial standards.

Function & Mechanism

  • PDE5 inhibition: Tadalafil selectively inhibits phosphodiesterase type 5, increasing cyclic guanosine monophosphate (cGMP) levels in smooth muscle cells.
  • Vasodilation: Elevated cGMP promotes relaxation of vascular smooth muscle, enhancing blood flow to the corpus cavernosum and pulmonary arteries.
  • Prolonged action: With a half-life of approximately 17.5 hours, tadalafil provides a longer duration of effect compared to other PDE5 inhibitors.
  • Selectivity: Minimal inhibition of PDE6 and PDE11 reduces the risk of visual disturbances and musculoskeletal side effects.

Source & Standardization

  • Source: Chemically synthesized via a multi-step chiral process.
  • Standardization: ≥99.0% assay (HPLC), with strict control of chiral purity and related substances.
  • Forms: White to off-white crystalline powder.
  • Приложения: Pharmaceutical manufacturing of tablets for erectile dysfunction and pulmonary arterial hypertension; research use.

Quality Specifications (QC Tests)

Test Item Технические характеристики
Идентификация IR and HPLC retention time match reference standard
Потери при сушке ≤0,51 TP3T
Остаток после прокаливания ≤0,11 TP3T
Тяжелые металлы ≤20 ppm
Органические примеси Any individual ≤0.1%, total ≤0.5%
Остаточные растворители Meets ICH Q3C requirements
Microbial Limits Total aerobic count ≤1000 CFU/g, yeast and mold ≤100 CFU/g

Bulk Supply & Documentation

  • Monthly capacity: 500 kg
  • Срок выполнения заказа: 3–5 рабочих дней (товары, имеющиеся в наличии)
  • Documentation: COA, MSDS, TDS available upon request.
  • Packaging: 25 kg fiber drum with double polyethylene bags inside.

Frequently Asked Questions

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

Our standard MOQ is 1 kg. For larger quantities, please contact our sales team for pricing and availability.

How long does delivery take?

For stock items, delivery is typically 3-5 business days after order confirmation. We ship globally via express or air freight.

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

Yes, a COA is available for each batch. Samples can be provided upon request for evaluation purposes.

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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