Description

Tadalafil Impurity 48 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Tadalafil by serving as a known impurity marker. It is primarily required by pharmaceutical manufacturers, quality control (QC) laboratories, and research institutions engaged in method development, validation, and regulatory compliance testing.

Application

• Pharmaceutical Impurity Profiling and Identification: Used as a certified reference material (CRM) to identify and quantify Tadalafil Impurity 48 in API and finished drug products.
• Analytical Method Development and Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) for impurity detection in Tadalafil.
• Quality Control and Assurance (QC/QA): Serves as a critical standard in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency.
• Regulatory Compliance and Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing data on impurity characterization and control strategies.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Research and Development (R&D): Used in chemical and pharmacological research to study the degradation pathways and properties of Tadalafil.

Basic Information

Product Name	Tadalafil Impurity 48
CAS No.	859964-45-7
Molecular Formula	C22H19FN2O4
Molecular Weight	394.40 g/mol
Synonyms	(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; Tadalafil Related Compound 48; Tadalafil EP Impurity I; Tadalafil USP Impurity; Tadalafil Degradation Product; Tadalafil Process Impurity
EINECS	Contact for details

Quality Control

Our Tadalafil Impurity 48 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure it meets the high-purity standards required for pharmaceutical reference materials. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile, supporting compliance with ICH Q3A, Q3B, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C. The material is hygroscopic (moisture-sensitive) and should be kept in a dry environment. For long-term storage, consider storing under inert atmosphere.

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: ≤ 0.10% 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.