Description

Tadalafil Impurity A is a designated pharmaceutical impurity used as a certified reference standard in analytical chemistry. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Tadalafil during its development and manufacturing. It is primarily required by pharmaceutical companies, contract research organizations (CROs), and quality control laboratories for method validation, stability studies, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Tadalafil API and finished drug products.
• Method Development and Validation (HPLC/LC-MS): Essential for developing, validating, and verifying chromatographic methods to accurately identify and quantify this specific impurity.
• Quality Control and Batch Release: Employed in routine QC testing of Tadalafil raw materials and formulations to ensure they meet stringent pharmacopeial limits for impurities.
• Stability Studies: Used to monitor the formation of Tadalafil Impurity A over time under various stress conditions (e.g., heat, humidity, light) to establish product shelf life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity profiling and control strategies.
• Research and Development: Serves as a key intermediate or marker in the synthesis and purification process development of Tadalafil.

Basic Information

Product Name	Tadalafil Impurity A
CAS No.	951661-85-1
Molecular Formula	C₂₂H₁₉N₃O₄
Molecular Weight	389.41 g/mol
Synonyms	(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; Tadalafil Related Compound A; Tadalafil EP Impurity A; Tadalafil USP Impurity A; (6R-trans)-6-(1,3-Benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methylpyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione
EINECS	Contact for details

Quality Control

Our Tadalafil Impurity A is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity confirmation and structural characterization via NMR and MS, to ensure it meets the high standards required for use as a reference material. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic (moisture-sensitive) nature, the container should be kept in a desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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