Description

Tadalafil Impurity 35 is a high-purity 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, quality control laboratories, and research institutions for method development, validation, and impurity profiling. The reliable identification and quantification of this impurity are essential for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in tadalafil Active Pharmaceutical Ingredient (API) and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities during manufacturing.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to ensure tadalafil products comply with specifications from USP, EP, ICH, and other regulatory guidelines.
• Stability Studies: Used to track the formation of degradation products in tadalafil formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic chemistry research, metabolic studies, and the investigation of impurity formation pathways.

Basic Information

Item	Details
Product Name	Tadalafil Impurity 35
CAS No.	749864-17-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
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; Tadalafil EP Impurity; Tadalafil USP Impurity; Tadalafil Process Impurity; Tadalafil Degradant
EINECS	Contact for details

Quality Control

Every batch of Tadalafil Impurity 35 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure they meet the high standards required for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with relevant specifications.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. 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)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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