Description

Tadalafil Impurity D CAS NO 951661-81-7 is a high-purity reference standard used for the identification and quantification of a specific process-related impurity in Tadalafil Active Pharmaceutical Ingredient (API) and finished drug products. This compound is critical for pharmaceutical quality control and regulatory compliance, ensuring the safety and efficacy of the final medication. It is primarily required by analytical laboratories, pharmaceutical manufacturers, and regulatory bodies involved in research, development, and quality assurance of Tadalafil-based therapeutics.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for analytical method development, validation, and routine quality control testing of Tadalafil API.
• Impurity Profiling and Identification: Used in HPLC, UPLC, and LC-MS analyses to identify, characterize, and quantify Tadalafil Impurity D in drug substances and products.
• Regulatory Compliance and Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) to establish impurity limits and control strategies as per ICH Q3A and Q3B guidelines.
• Stability Studies: Employed to monitor the formation and level of this impurity during forced degradation and long-term stability studies of Tadalafil formulations.
• Process Chemistry Research: Serves as a marker to optimize synthesis and purification processes to minimize the formation of this specific impurity.
• Quality Assurance/Quality Control (QA/QC): Used for system suitability testing, calibration, and as an external standard to ensure the accuracy and precision of analytical instruments and methods.

Basic Information

Product Name	Tadalafil Impurity D
CAS No.	951661-81-7
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 D; Tadalafil EP Impurity D; Tadalafil USP Impurity D; (6R-trans)-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; UNII-9F8S6A3D4C; 9F8S6A3D4C
EINECS	Contact for details

Quality Control

Every batch of Tadalafil Impurity D is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopoeial guidelines (e.g., USP, EP). Comprehensive characterization is performed using advanced techniques such as HPLC, GC, NMR, and MS. Certificates of Analysis (COA) detailing purity, identity, and impurity profiles are provided and available upon request to support your regulatory and quality needs.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to maintain stability and purity. Keep the container tightly sealed in a cool, dry, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%
Heavy Metals	≤ 20 ppm

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