Description

Tadalafil Impurity 35 is a high-purity reference standard used in the analytical profiling and quality control of pharmaceutical active ingredients. This compound is critical for ensuring the safety and efficacy of drug products by enabling the accurate identification and quantification of process-related impurities. It is an essential material for pharmaceutical R&D laboratories, quality assurance departments, and regulatory affairs teams focused on the development and manufacture of tadalafil-based therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the calibration of analytical instruments and validation of test methods.
• Impurity Profiling & Characterization: Used in method development and validation for HPLC, UPLC, and LC-MS to identify and quantify Tadalafil-related impurities.
• Quality Control & Assurance (QC/QA): A critical component in the batch release testing of Active Pharmaceutical Ingredients (APIs) to ensure compliance with ICH Q3A/B guidelines.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission dossiers (e.g., for FDA, EMA) by providing definitive impurity identification data.
• Stability Studies: Employed as a marker to monitor impurity formation in drug substances and products under various stress conditions.
• Research & Development: Facilitates process chemistry optimization by helping to trace the origin and formation pathway of synthetic impurities.

Basic Information

Product Name	Tadalafil Impurity 35
CAS No.	1978323-00-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Tadalafil Related Compound 35; Tadalafil EP Impurity 35; Tadalafil USP Impurity 35; (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 Impurity; Tadalafil Process Impurity; Cialis Impurity 35
EINECS	Contact for details

Quality Control

Our Tadalafil Impurity 35 is manufactured under strict quality management systems. Each batch undergoes comprehensive analytical testing, including HPLC purity assay, related substance analysis, and confirmatory identification (IR, NMR, MS). We provide full traceability and a detailed Certificate of Analysis (COA) with each shipment, ensuring compliance with current pharmacopeial standards (USP, EP) and ICH guidelines for impurity standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The material is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C

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