Description

Tadalafil Impurity 8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of pharmaceutical products containing tadalafil. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling. The material is supplied with comprehensive analytical data to support stringent quality control protocols.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in tadalafil Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development & Validation: Essential for developing and validating chromatographic methods (HPLC, UPLC) to monitor impurities during API synthesis and formulation.
• Quality Control & Assurance (QC/QA): Serves as a system suitability and calibration standard in routine quality control testing to ensure batch-to-batch consistency and compliance with pharmacopeial limits (e.g., ICH Q3A/B).
• Regulatory Submissions: Provides necessary impurity data for regulatory filings (e.g., FDA, EMA) to demonstrate thorough characterization and control of the drug substance.
• Stability Studies: Employed to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Research & Development: Used in synthetic chemistry research to study degradation pathways and to develop improved purification processes for tadalafil.

Basic Information

Product Name	Tadalafil Impurity 8
CAS No.	1803592-02-0
Molecular Formula	C22H18F3N3O4
Molecular Weight	445.39 g/mol
Synonyms	(6R,12aR)-2,3,6,7,12,12a-Hexahydro-6-(1,1-dimethylethyl)-2-methylpyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione, 9-(Trifluoromethyl)-; Tadalafil Related Compound 8; Tadalafil EP Impurity H; Tadalafil USP Impurity 8; Tadalafil Degradant; Tadalafil Process Impurity
EINECS	Contact for details

Quality Control

Every batch of Tadalafil Impurity 8 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing purity, identity, and impurity profile. We support compliance with ICH guidelines and can supply materials suitable for use in regulatory submissions.

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); ensure the container is sealed tightly after each use to prevent exposure to atmospheric moisture. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
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%

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