Description

Tadalafil Impurity 11 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Tadalafil by serving as a benchmark in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and quality control processes. The reliable identification and quantification of this impurity are essential for meeting stringent global pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Tadalafil API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, optimizing, and validating chromatographic methods to detect and quantify impurities.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity profiles and ensure product consistency and compliance with specifications.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity identification and control strategies.
• Stability Studies: Used to track the formation of degradation products in Tadalafil formulations under various stress conditions.
• Research & Process Chemistry: Aids in understanding the synthesis pathway of Tadalafil and in optimizing manufacturing processes to minimize impurity formation.

Basic Information

Product Name	Tadalafil Impurity 11
CAS No.	1492563-70-8
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 11; Tadalafil EP Impurity J; Tadalafil USP Impurity 11; Tadalafil Process Impurity; UNII-1G8VK1958U
EINECS	Contact for details

Quality Control

Every batch of Tadalafil Impurity 11 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents, to ensure it meets the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing all test results and specifications is provided with each shipment.

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 material is hygroscopic (moisture-sensitive) and must be kept under dry conditions to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
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.