Description

n-Desmethyl-n-Cyclopentyl cis-Ent-Tadalafil is a high-purity pharmaceutical intermediate and reference standard of significant importance in research and development. This compound is a key structural analog used for the synthesis, characterization, and quality control of active pharmaceutical ingredients (APIs) within the PDE5 inhibitor class. It is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions focused on developing and validating therapeutic agents for erectile dysfunction and pulmonary arterial hypertension.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the qualitative and quantitative analysis of related APIs via HPLC, LC-MS, and other chromatographic methods.
• Process Research & Development (R&D): Serves as a critical intermediate or starting material in the synthetic pathway for novel PDE5 inhibitors and related compounds.
• Impurity Profiling: Employed as a marker to identify, quantify, and control process-related impurities and degradation products in final drug substance batches.
• Metabolite Studies: Utilized in pharmacological and pharmacokinetic research to study drug metabolism pathways and identify potential active metabolites.
• Analytical Method Development: Acts as a key component for developing, validating, and transferring robust analytical methods in quality control laboratories.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., with FDA, EMA) by providing well-characterized materials for stability studies and specification setting.

Basic Information

Product Name	n-Desmethyl-n-Cyclopentyl cis-Ent-Tadalafil
CAS No.	171488-19-0
Molecular Formula	C₂₈H₃₃N₃O₄
Molecular Weight	475.58 g/mol
Synonyms	(6R,12aR)-2,3,6,7,12,12a-Hexahydro-2-(1,3-benzodioxol-5-yl)-6-(cyclopentylmethyl)pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione; cis-Ent-Tadalafil N-Desmethyl-N-Cyclopentyl Analog; Tadalafil Impurity; Tadalafil Related Compound; PDE5 Inhibitor Intermediate; (6R,12aR)-6-(Cyclopentylmethyl)-2-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione
EINECS	Contact for details

Quality Control

Our n-Desmethyl-n-Cyclopentyl cis-Ent-Tadalafil is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, identity confirmation by IR and MS, and residual solvent analysis to ensure it meets exacting standards for pharmaceutical research. A detailed Certificate of Analysis (COA) is provided with every shipment, documenting the complete set of specifications and test results.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This material is moisture-sensitive; keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤ 0.5%

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