Description

Tadalafil Impurity 66 is a high-purity 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 key marker for impurity profiling and control. It is an essential material for analytical chemists and quality control laboratories in the pharmaceutical industry, particularly those involved in method development, stability studies, and regulatory compliance for PDE5 inhibitor medications.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the qualitative and quantitative analysis of Tadalafil and related substances.
• Impurity Identification and Control: Critical for identifying, monitoring, and controlling this specific impurity during the manufacturing process of Tadalafil API to meet ICH Q3A/B guidelines.
• Analytical Method Development and Validation: Used as a system suitability and calibration standard in HPLC, UPLC, and LC-MS methods to ensure accurate and reliable impurity detection.
• Stability Studies: Employed to track the formation of degradation products in Tadalafil drug products and formulations under various stress conditions.
• Regulatory Submissions: Provides essential data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control strategies.
• Quality Control (QC) Testing: Serves as a benchmark in routine QC testing of Tadalafil batches to ensure they conform to strict pharmacopeial (e.g., USP, EP) and in-house specifications.

Basic Information

Product Name	Tadalafil Impurity 66
CAS No.	1598416-07-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tadalafil Related Compound 66; Tadalafil EP Impurity G; Tadalafil USP Impurity; (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 Impurity; PDE5 Inhibitor Impurity; Tadalafil Degradant; Tadalafil Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Tadalafil Impurity 66 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, LC-MS, NMR, and IR to ensure compliance with pharmacopeial standards and customer-specific requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, analytical methods, and traceability.

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 anhydrous conditions. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Retention time corresponds to reference standard
Identification (IR)	Spectrum matches reference spectrum
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)	≤ 5.0% w/w

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