Description

Tadalafil Impurity 67 is a high-purity chemical 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, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Tadalafil Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development and Validation in Quality Control (QC) and Research & Development (R&D) laboratories.
• Stability Studies to monitor impurity profiles and degradation pathways of tadalafil under various storage conditions.
• Regulatory Compliance and Documentation, supporting submissions to agencies like the FDA, EMA, and other global health authorities.
• Process Chemistry Research to understand and control impurity formation during the synthesis of tadalafil.
• Calibration of Analytical Instruments such as High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) systems.

Basic Information

Product Name	Tadalafil Impurity 67
CAS No.	1863191-32-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tadalafil Related Compound 67; Tadalafil Impurity 67; Tadalafil EP Impurity 67; Tadalafil USP Impurity 67; (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 Impurity; PDE5 Inhibitor Impurity; Cialis Impurity
EINECS	Contact for details

Quality Control

Our Tadalafil Impurity 67 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with every shipment, detailing all test results and specifications.

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 solid
Identification (IR)	Conforms to reference spectrum
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 guidelines
Water Content (KF)	≤ 1.0%

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