Description

Tadalafil Impurity 53 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for the quality control and regulatory compliance of active pharmaceutical ingredients (APIs), specifically for the drug Tadalafil. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies for method validation, impurity profiling, and batch release testing. Ensuring the identity and purity of this impurity is fundamental to maintaining drug safety and efficacy.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of Tadalafil Impurity 53 in drug substances and products.
• Analytical Method Development & Validation: Used in HPLC, UPLC, and LC-MS methods to establish specificity, accuracy, and detection limits for impurity analysis.
• Quality Control & Assurance (QC/QA): Essential for routine batch analysis in API manufacturing to ensure impurity levels remain within ICH (International Council for Harmonisation) guidelines.
• Regulatory Submissions: Supports the preparation of Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA and EMA.
• Stability Studies: Employed to monitor the formation of degradation products in Tadalafil formulations under various stress conditions.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes.

Basic Information

Product Name	Tadalafil Impurity 53
CAS No.	477970-20-0
Molecular Formula	C22H19F3N2O4
Molecular Weight	432.39 g/mol
Synonyms	(6R,12aR)-6-(1,3-Benzodioxol-5-yl)-2-(trifluoromethyl)-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 Process Impurity; Tadalafil Degradant; Cialis Impurity
EINECS	Contact for details

Quality Control

Our Tadalafil Impurity 53 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity, identity confirmation (IR, MS), and residual solvent analysis, to ensure it meets the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against established specifications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The material should be kept in a cool, dry, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to prevent potential degradation.

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: ≤ 0.10% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 0.5% w/w

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