Description

Imidafenacin Related Compound 1 (4-(1H-Imidzol-1-Yl)-2,2-Diphenylbutanamide) is a high-purity reference standard and pharmaceutical intermediate critical for quality control and research in drug development. This compound is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient imidafenacin, an antimuscarinic agent used to treat overactive bladder. It is primarily utilized by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in method validation, impurity profiling, and regulatory compliance. The availability of this well-characterized related substance is fundamental for maintaining stringent quality standards throughout the pharmaceutical supply chain.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material for the identification and quantification of specific impurities in Imidafenacin Active Pharmaceutical Ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Used as a critical standard to develop, calibrate, and validate high-performance liquid chromatography (HPLC) and other chromatographic methods for quality assurance.
• Stability Studies and Forced Degradation Testing: Employed as a marker to monitor the formation of related substances under various stress conditions, ensuring drug product shelf-life and safety.
• Regulatory Submissions and Compliance: Provides essential data for regulatory filings (e.g., with FDA, EMA) to demonstrate comprehensive impurity control strategies as per ICH guidelines Q3A(R2) and Q3B(R2).
• Chemical Synthesis Research: Acts as a key intermediate or a comparative standard in synthetic chemistry research for developing novel derivatives or optimizing manufacturing processes.
• Quality Control Laboratory Testing: Used in routine batch release testing of Imidafenacin API to ensure it meets the strict purity specifications outlined in pharmacopeial monographs.

Basic Information

Product Name	Imidafenacin Related Compound 1
CAS No.	170105-20-1
Molecular Formula	C19H19N3O
Molecular Weight	305.38 g/mol
Synonyms	4-(1H-Imidazol-1-yl)-2,2-diphenylbutanamide; 2,2-Diphenyl-4-(1H-imidazol-1-yl)butanamide; Imidafenacin Impurity; Imidafenacin Related Substance 1; KRP-197/RC1; 1H-Imidazole-1-butanaMide, 4-(1H-iMidazol-1-yl)-2,2-diphenyl-; (RS)-4-(1H-Imidazol-1-yl)-2,2-diphenylbutyramide
EINECS	Contact for details

Quality Control

Every batch of Imidafenacin Related Compound 1 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity confirmation, purity assay, and impurity profiling using advanced analytical techniques such as HPLC, GC, NMR, and mass spectrometry to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment, supporting your regulatory and quality assurance requirements.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15°C and 25°C (59°F and 77°F), in a dry environment. The container should be kept securely sealed to protect the contents from moisture.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C
Loss on Drying	≤ 0.5%

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