Description

Imidafenacin Related Compound 6 (4-Acetimidoylamino-2,2-Diphenylbutanamide) is a high-purity chemical reference standard, essential for pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient imidafenacin through precise analytical control. It is primarily used by analytical chemists, quality control laboratories, and R&D departments within the pharmaceutical and fine chemical industries. The material is supplied with comprehensive analytical data to support regulatory filings and method validation.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for identifying and quantifying related substances in imidafenacin drug substance and finished products.
• Analytical Method Development and Validation: Used as a critical standard to develop, calibrate, and validate chromatographic methods such as HPLC and UPLC.
• Quality Control and Assurance (QC/QA): Employed in routine batch testing to monitor impurity levels and ensure compliance with ICH guidelines and pharmacopeial standards.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies of imidafenacin formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used to study and optimize synthetic pathways for imidafenacin, helping to understand and minimize the formation of this specific impurity.

Basic Information

Product Name	Imidafenacin Related Compound 6
CAS No.	503598-33-2
Molecular Formula	C19H21N3O2
Molecular Weight	323.39 g/mol
Synonyms	4-Acetimidoylamino-2,2-Diphenylbutanamide; 2,2-Diphenyl-4-[(1E)-N-(aminoiminomethyl)acetamido]butanamide; Imidafenacin Impurity; Imidafenacin Related Substance 6; UNII-9V6F0S2C2I; Butanamide, 4-[(aminoiminoacetyl)amino]-2,2-diphenyl-; 4-[(Aminoiminoacetyl)amino]-2,2-diphenylbutanamide
EINECS	Contact for details

Quality Control

Every batch of Imidafenacin Related Compound 6 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques to ensure compliance with industry standards for reference materials. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. We support compliance with ICH Q3A, Q3B, and Q6A guidelines.

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 product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider desiccated conditions.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 0.5%
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.