Description

cis-Ent-Tadalafil is a specific stereoisomer of the well-known pharmaceutical compound Tadalafil, identified by the CAS number 171596-28-4. This high-purity chemical intermediate is critical for research and development in the pharmaceutical sector, particularly for studying structure-activity relationships and developing novel therapeutic agents. It is primarily utilized by pharmaceutical R&D laboratories, analytical reference standard suppliers, and manufacturers of active pharmaceutical ingredients (APIs) who require precise and well-characterized chemical entities.

Application

• Pharmaceutical Research & Development (R&D): Serves as a key intermediate and reference standard for the synthesis and analytical method development of PDE5 inhibitors.
• Analytical Reference Standard: Used in high-performance liquid chromatography (HPLC), mass spectrometry (MS), and other analytical techniques for quality control and impurity profiling of Tadalafil-based products.
• Chemical Synthesis: Acts as a building block for the preparation of novel chemical analogs and derivatives in medicinal chemistry programs.
• Academic Research: Employed in university and institutional laboratories for pharmacological studies and biochemical research related to phosphodiesterase enzymes.
• Regulatory Compliance Testing: Essential for conducting stability studies, method validation, and meeting regulatory submission requirements for drug master files (DMFs).

Basic Information

Product Name	cis-Ent-Tadalafil
CAS No.	171596-28-4
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; cis-Enantiomer Tadalafil; (6R,12aR)-Tadalafil; Tadalafil Impurity; Tadalafil Related Compound; PDE5 Inhibitor Intermediate
EINECS	Contact for details

Quality Control

Our cis-Ent-Tadalafil is manufactured under strict quality management systems to ensure batch-to-batch consistency and high purity. Each lot undergoes comprehensive analytical testing, including HPLC for assay and impurity profiling, to meet exacting research-grade specifications. A detailed Certificate of Analysis (COA) providing full characterization data (including chiral purity) is supplied with every shipment to support your quality assurance and regulatory needs.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

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	≥ 99.0%
Related Substances (HPLC)	Individual impurity ≤ 0.5% Total impurities ≤ 1.0%
Residual Solvents (GC)	Complies with ICH guidelines
Loss on Drying	≤ 0.5%

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