Pure Tadalafil Raw Material Powder

Pure Tadalafil Raw Material Powder is a white, odorless crystalline API. Its molecular formula is C22H19N3O4 with a molecular weight of 389.40. It is commonly supplied in the form of Pure Tadalafil Raw Material Powder for pharmaceutical compounding.

Product Name: Tadalafil
Appearance: White crystalline powder
Assay/Purity: ≥99.0% (HPLC)
CAS No.: 171596-29-5
Molecular Formula: C22H19N3O4
Molecular Weight: 389.40
Quality System/Compliance: GMP / USP / EP
Manufacturing Capability: 1 factory, 3 production lines; GMP cleanroom; 2 independent laboratories
Packaging: 1 kg aluminum foil bag / 25 kg drum
Storage: Store in a cool, dry place, protected from light
MOQ: 1 kg

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Genbay Biotechnology Co., Ltd. provides high-grade Pure Tadalafil Raw Material Powder as a premium pharmaceutical active ingredient (API) for global supply, used for erectile dysfunction (ED) research, pulmonary arterial hypertension (PAH) treatments, and benign prostatic hyperplasia (BPH) management. Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Pure Tadalafil Raw Material Powder functions primarily by relaxing smooth muscle cells and increasing blood flow to specific tissues. Our manufacturing process ensures a high-purity crystalline form with superior molecular stability, making it the premier choice for advanced pharmaceutical formulations, clinical trials, and high-end healthcare products.

Specification

The following data represents the typical profile.

  • Assay: 98.0% to 102.0% (HPLC, on anhydrous basis)
  • Appearance: White or almost white crystalline powder
  • Loss on Drying: ≤0.5%
  • Residue on Ignition: ≤0.1%
  • Heavy Metals: ≤20 ppm
  • Solubility: Practically insoluble in water; freely soluble in dimethyl sulfoxide; slightly soluble in methylene chloride.
Uses
  • PDE5 Inhibition Research: The primary direct use of Pure Tadalafil Raw Material Powder is in pharmaceutical formulations designed to treat erectile dysfunction by enhancing the effects of nitric oxide.
  • Pulmonary Hypertension Studies: Used in clinical-grade medications to reduce pressure in the blood vessels leading to the lungs, improving exercise capacity in patients.
  • BPH Symptom Management: Utilized in systemic treatments to relieve symptoms of an enlarged prostate by relaxing muscles in the bladder and prostate.
  • Pharmacokinetic Testing: Acts as a critical reference standard in laboratory settings for studying drug-drug interactions and metabolic pathways.
  • Controlled Release Development: Increasingly used in research for long-acting or fast-disintegrating drug delivery systems due to its prolonged half-life (up to 36 hours).
Quality Assurance & Certifications

Genbay produces in state-of-the-art facilities that strictly adhere to international USP, EP, and GMP pharmaceutical standards.

  • Testing Protocol: Every batch is subjected to rigorous analytical procedures, including HPLC for purity verification, NMR/IR for structural identity, and full impurity profiling (related substances).
  • Certifications: Our production infrastructure is ISO and GMP certified, ensuring a reliable and consistent supply chain for the global pharmaceutical industry.
  • Documentation: We provide a comprehensive Certificate of Analysis (COA) and Material Safety Data Sheet (MSDS) with every shipment to ensure professional transparency and regulatory compliance.
Packaging & Shipping
  • Packaging: 1 kg aluminum foil bags with double-layered vacuum sealing or 25 kg industrial-grade fiber drums for large-scale manufacturing requirements.
  • Shipping: We offer secure and discreet international shipping through professional logistics partners to ensure the material remains stable and confidential during transit.
  • Storage: Pure Tadalafil Raw Material Powder should be stored at room temperature (15°C to 30°C), protected from light and moisture, and kept in a tightly closed container.
Frequently Asked Questions(FAQ)

Q1: What makes Tadalafil different from Sildenafil (Viagra)?
A1: Pure Tadalafil Raw Material Powder is known for its longer duration of action (up to 36 hours) compared to Sildenafil (4-6 hours), earning it the nickname “the weekend pill.”

Q2: Is this material suitable for research or manufacturing?
A2: We provide high-purity API grade suitable for both advanced pharmaceutical R&D and large-scale commercial manufacturing.

Q3: What is the shelf life of the material?
A3: When stored under recommended conditions in its original sealed packaging, the shelf life is typically 36 months from the date of manufacture.

Q4:  What is the typical lead time for an international order?
A4: Standard orders are processed and dispatched within 3 to 5 business days, followed by worldwide tracked delivery.

Ready to request price, stock availability, or samples of Pure Tadalafil Raw Material Powder?

Email: info@genbaybio.com

WhatsApp/Telegram: +852 94249370

Contact Genbay Biotechnology Co., Ltd.

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