Description

Tadalafil CAS NO 171596-29-5 is a potent and selective inhibitor of phosphodiesterase type 5 (PDE5), a key enzyme in the regulation of blood flow. This high-purity active pharmaceutical ingredient (API) is critical for ensuring the efficacy and safety of finished pharmaceutical formulations. It is primarily required by pharmaceutical manufacturers and research institutions engaged in the development and production of treatments for erectile dysfunction and pulmonary arterial hypertension.

Application

• As the active pharmaceutical ingredient (API) in the manufacture of prescription medications for erectile dysfunction (ED).
• As a key component in the formulation of drugs for the treatment of pulmonary arterial hypertension (PAH).
• In pharmaceutical research and development (R&D) for studying PDE5 inhibition and related therapeutic pathways.
• For the development of controlled-release or other novel dosage forms to improve patient compliance.
• As a reference standard in analytical laboratories for quality control and method validation.
• In the synthesis of pharmaceutical intermediates or for further chemical modification in advanced drug discovery.

Basic Information

Product Name	Tadalafil
CAS No.	171596-29-5
Molecular Formula	C₂₂H₁₉N₃O₄
Molecular Weight	389.41 g/mol
Synonyms	(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; Cialis (brand name); Adcirca (brand name); IC-351; GF196960; PDE5 Inhibitor IC-351
EINECS	Contact for details

Quality Control

Our Tadalafil API is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing to ensure it meets stringent specifications for identity, purity, and potency, aligning with ICH guidelines and current Good Manufacturing Practices (cGMP). A detailed Certificate of Analysis (COA) is provided with every shipment, confirming compliance with agreed-upon specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Keep the container tightly sealed in a dry environment to prevent moisture absorption.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time conforms to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Related Substances (HPLC)	Individual impurity: NMT 0.5% Total impurities: NMT 1.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	NMT 0.5%
Residue on Ignition	NMT 0.1%
Heavy Metals	NMT 20 ppm

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.