Description

Tadalafil Impurity 39 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. The material is supplied with comprehensive analytical data to support method validation and regulatory filings.

Application

• Pharmaceutical Reference Standard: Used 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: Essential for developing, calibrating, and validating chromatographic methods, such as HPLC and UPLC, in quality control laboratories.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents (e.g., for FDA, EMA) by providing definitive impurity characterization data.
• Stability Studies: Employed to monitor the formation of this specific degradation product during forced degradation and long-term stability testing of tadalafil formulations.
• Research & Development: Used in pharmacokinetic and metabolic studies to understand the impurity's profile and its potential impact.
• Quality Assurance/Quality Control (QA/QC): Serves as a system suitability test component and for routine batch release testing to ensure API and drug product purity.

Basic Information

Product Name	Tadalafil Impurity 39
CAS No.	2058231-08-4
Molecular Formula	C₂₂H₁₉F₃N₂O₄
Molecular Weight	432.39 g/mol
Synonyms	(6R,12aR)-2,3,6,7,12,12a-Hexahydro-6-(1,3-benzodioxol-5-yl)-2-methylpyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione Trifluoroacetate; Tadalafil Related Compound 39; Tadalafil EP Impurity I; Tadalafil USP Impurity; Tadalafil Trifluoroacetate Salt Impurity
EINECS	Contact for details

Quality Control

Our Tadalafil Impurity 39 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC for purity, NMR and MS for structural confirmation, and residual solvent analysis. We provide full traceability and Certificates of Analysis (COA) that detail all test results against stringent in-house specifications, supporting compliance with ICH guidelines and pharmacopeial standards (USP/EP).

Storage

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

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 5.0%

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