Description

Tadalafil Impurity 19 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of pharmaceutical products containing tadalafil by serving as a benchmark in impurity profiling and method validation. It is an essential material for pharmaceutical manufacturers, quality control laboratories, and research institutions focused on API development and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of impurities in tadalafil active pharmaceutical ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Used to develop, optimize, and validate chromatographic methods (e.g., HPLC, UPLC) for impurity detection and separation.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure product specifications meet pharmacopeial standards (USP, EP).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies of tadalafil to understand degradation pathways.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to regulatory bodies like the FDA and EMA.
• Research & Development: Utilized in synthetic chemistry research to study the formation, fate, and purge of process-related impurities.

Basic Information

Product Name	Tadalafil Impurity 19
CAS No.	477970-21-1
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; 2-Trifluoromethyl Tadalafil Dioxole Impurity
EINECS	Contact for details

Quality Control

Our Tadalafil Impurity 19 is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide a detailed Certificate of Analysis (COA) with each shipment, which includes batch-specific data, chromatograms, and traceability information. Our quality standards are designed to support compliance with cGMP, ICH Q3A/B guidelines, and major pharmacopeias.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation.

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)	Any individual impurity ≤ 1.0% Total impurities ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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