Description

Imidafenacin Related Compound 7 is a high-purity chemical reference standard, specifically identified as CAS NO 191592-57-1. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Imidafenacin during development and manufacturing. It serves as an essential analytical tool for pharmaceutical R&D laboratories and quality control units engaged in method validation, impurity profiling, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling and Identification in the synthesis and quality control of Imidafenacin.
• Analytical Method Development and Validation for HPLC, LC-MS, and other chromatographic techniques.
• Stability Studies to monitor and quantify degradation products in drug substance and product formulations.
• Regulatory Compliance and Submission, providing a certified reference material for ICH guidelines (Q3A, Q3B).
• Pharmacopoeial Testing, supporting compliance with USP, EP, or JP monograph requirements for Imidafenacin.
• Calibration Standard for quantitative analysis in quality assurance laboratories.

Basic Information

Product Name	Imidafenacin Related Compound 7
CAS No.	191592-57-1
Molecular Formula	C20H21N3O2
Molecular Weight	335.40 g/mol
Synonyms	Imidafenacin Impurity 7; Imidafenacin Related Substance 7; 4-(2-Methyl-1H-imidazol-1-yl)-2,2-diphenylbutanamide; 1-(2,2-Diphenyl-4-(2-methyl-1H-imidazol-1-yl)butyl)urea (alternative structural representation); Imidafenacin Process Impurity; KRP-197/007; UNII-Contact for details
EINECS	Contact for details

Quality Control

Every batch of Imidafenacin Related Compound 7 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and compliance with in-house specifications aligned with ICH guidelines. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

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) and should be handled in a dry environment to prevent degradation.

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)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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