Description

Tadalafil Impurity 64 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Tadalafil, a medication used to treat erectile dysfunction and pulmonary arterial hypertension. It is an essential tool for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in research, development, and compliance testing. The precise characterization of this impurity is vital for meeting stringent pharmacopeial standards and regulatory submission requirements.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Tadalafil Impurity 64 in API and finished drug products.
• Analytical Method Development & Validation: Critical for developing, optimizing, and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Used in routine batch release testing to monitor and control impurity levels, ensuring compliance with ICH Q3A/B guidelines.
• Stability Studies: Employed to track the formation and growth of this specific impurity under various stress and long-term storage conditions.
• Regulatory Compliance & Filings: Essential for preparing documentation for regulatory submissions to agencies like the FDA, EMA, and PMDA.
• Research & Development (R&D): Used in synthetic route optimization and process chemistry to understand and minimize impurity formation during API manufacturing.

Basic Information

Product Name	Tadalafil Impurity 64
CAS No.	629652-67-1
Molecular Formula	C22H19FN2O4
Molecular Weight	394.40 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; Tadalafil EP Impurity; Tadalafil USP Impurity; Tadalafil Process Impurity; (6R-trans)-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
EINECS	Contact for details

Quality Control

Every batch of Tadalafil Impurity 64 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the exacting standards of the pharmaceutical industry, with testing protocols aligned with current pharmacopeial methods (USP/EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, and other critical parameters.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). Keep the container in a dry, cool, and well-ventilated area. For long-term storage under inert atmosphere, please contact us for specific recommendations.

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 2.0%

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