Description

Tadalafil Impurity 20 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing tadalafil. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and research institutions involved in drug development and impurity profiling.

Application

• As a certified reference standard for the identification and quantification of impurities in Tadalafil Active Pharmaceutical Ingredient (API) and finished dosage forms.
• For method development and validation of analytical procedures, including HPLC, UPLC, and LC-MS.
• In pharmaceutical research and development to study the degradation pathways and stability profile of tadalafil.
• For regulatory compliance and documentation, supporting submissions to agencies like the FDA, EMA, and other global health authorities.
• Use in quality control laboratories for routine batch testing and release of tadalafil-based products.
• As a critical component in impurity isolation and characterization studies.

Basic Information

Product Name	Tadalafil Impurity 20
CAS No.	406938-39-4
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; Tadalafil Related Compound; Tadalafil EP Impurity; Tadalafil USP Impurity; Tadalafil Degradant; Tadalafil Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Tadalafil Impurity 20 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile by validated methods (e.g., HPLC, NMR) is provided with each shipment to support your regulatory and quality assurance needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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