Tadalafil

Tadalafil

Parametr Specyfikacja
Nazwa produktu Tadalafil
Inne nazwy IC351, GF196960
Numer CAS 171596-29-5
Wzór cząsteczkowy C22H19N3O4
Masa cząsteczkowa 389.4 g/mol
Wygląd Biały lub prawie biały krystaliczny proszek
Oznaczenie (HPLC) ≥99,01 TP3T
Rozpuszczalność Sparingly soluble in DMSO, practically insoluble in water
Opakowanie 25 kg fiber drum, double polyethylene bags inside

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Tadalafil Structure

Synonimy: 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

  • Źródło: 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.
  • Zastosowania: Pharmaceutical manufacturing of tablets for erectile dysfunction and pulmonary arterial hypertension; research use.

Quality Specifications (QC Tests)

Test Item Specyfikacja
Identyfikacja IR and HPLC retention time match reference standard
Strata przy suszeniu ≤0.5%
Popiół po spaleniu ≤0,11 TP3T
Metale ciężkie ≤20 ppm
Organic Impurities Any individual ≤0.1%, total ≤0.5%
Pozostałości rozpuszczalników Meets ICH Q3C requirements
Wartości graniczne dla mikroorganizmów Total aerobic count ≤1000 CFU/g, yeast and mold ≤100 CFU/g

Bulk Supply & Documentation

  • Miesięczna wydajność: 500 kg
  • Czas realizacji: 3–5 dni roboczych (towary dostępne w magazynie)
  • Dokumentacja: COA, MSDS, TDS available upon request.
  • Opakowanie: 25 kg fiber drum with double polyethylene bags inside.

Najczęściej zadawane pytania

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

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