Description

Ent-Tadalafil CAS NO 629652-72-8 is a high-purity enantiomer of the pharmaceutical compound Tadalafil, distinguished by its specific stereochemistry. This compound is of critical importance in pharmaceutical research and development, serving as a key reference standard and a potential intermediate for novel therapeutic agents. It is primarily required by research institutions, analytical laboratories, and pharmaceutical companies engaged in the development of PDE5 inhibitors, method validation, and impurity profiling.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of Tadalafil and its related substances in drug products and raw materials.
• Analytical Research: Serves as a critical impurity marker or chiral standard in HPLC, LC-MS, and other chromatographic methods for method development and validation.
• Process Chemistry & Development: Acts as a key intermediate or starting material in the research-scale synthesis of novel chemical entities targeting phosphodiesterase enzymes.
• Bioavailability & Pharmacokinetic Studies: Utilized in comparative studies to understand the stereospecific absorption, distribution, metabolism, and excretion (ADME) profiles.
• Regulatory Compliance & Documentation: Essential for preparing impurity profiles, regulatory submissions (e.g., ANDA, NDA), and stability studies as per ICH guidelines.
• Academic Research: Employed in universities and research institutes for studying enzyme inhibition mechanisms, structure-activity relationships (SAR), and crystallography.

Basic Information

Product Name	Ent-Tadalafil
CAS No.	629652-72-8
Molecular Formula	C₂₂H₁₉N₃O₄
Molecular Weight	389.41 g/mol
Synonyms	(6R,12aR)-2,3,6,7,12,12a-Hexahydro-2-methyl-6-(3,4-methylenedioxyphenyl)pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione; (6R,12aR)-Tadalafil; (R,R)-Tadalafil; Tadalafil Enantiomer; Tadalafil Impurity; UNII-742SXX0ICT; PDE5 Inhibitor Enantiomer
EINECS	Contact for details

Quality Control

Every batch of Ent-Tadalafil is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including chiral purity verification, to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing identity, purity, and chromatographic data is provided with each shipment to support your research and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This product is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Chiral Purity (Chiral HPLC)	≥ 99.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Loss on Drying	≤ 0.5%
Residue on Ignition	≤ 0.1%

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