Description

Tadalafil Impurity C CAS NO 951661-84-0 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 pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development, production, and quality assurance of Tadalafil-based therapeutics.

Application

• Pharmaceutical Impurity Profiling and Characterization: Used as a certified reference material (CRM) to identify and quantify Impurity C in Tadalafil API and drug formulations.
• Analytical Method Development and Validation: Serves as a critical standard for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods for impurity analysis.
• Quality Control and Release Testing: Essential for routine batch analysis in pharmaceutical QC laboratories to ensure impurity levels meet pharmacopeial (USP, EP) and ICH Q3A/B guidelines.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug shelf-life studies.
• Regulatory Submissions: Provides necessary data for Drug Master Files (DMFs), Common Technical Documents (CTDs), and other regulatory filings to demonstrate comprehensive impurity control.
• Research and Development: Used in process chemistry R&D to understand and minimize the formation of this impurity during Tadalafil synthesis.

Basic Information

Product Name	Tadalafil Impurity C
CAS No.	951661-84-0
Molecular Formula	C22H19N3O4
Molecular Weight	389.41 g/mol
Synonyms	(6R,12aR)-6-Methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione; Tadalafil Related Compound C; Tadalafil EP Impurity C; Tadalafil USP Impurity C; Tadalafil Process Impurity C; (6R-trans)-6-Methyl-2,3,6,7,12,12a-hexahydropyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione; UNII-1VK8S1X9QJ
EINECS	Contact for details

Quality Control

Every batch of Tadalafil Impurity C is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced chromatographic (HPLC, UPLC) and spectroscopic (NMR, MS) techniques to ensure it meets the stringent requirements for a pharmaceutical reference standard. A comprehensive Certificate of Analysis (CoA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant standards.

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, consider storing under inert atmosphere to ensure maximum stability.

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)	Any individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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