Description

Imidafenacin Impurity CAS NO 503599-41-5 is a high-purity chemical reference standard used in the pharmaceutical development and manufacturing process. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Imidafenacin. It serves as a key analytical marker for identification and quantification of specific impurities during method validation and routine quality control. Pharmaceutical manufacturers, analytical laboratories, and regulatory affairs departments require this standard to meet stringent pharmacopeial guidelines and ensure batch-to-batch consistency.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material for the identification and quantification of specific process-related impurities in Imidafenacin API.
• Analytical Method Development and Validation: Essential for developing, validating, and transferring HPLC, UPLC, or LC-MS methods in quality control laboratories.
• Stability Studies: Employed as a marker to monitor impurity formation and degradation pathways in Imidafenacin drug products under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate control strategies for impurities as per ICH Q3A and Q3B guidelines.
• Quality Control and Batch Release: Serves as a system suitability standard and for setting specification limits in the routine release testing of Imidafenacin batches.
• Research and Development: Used in synthetic chemistry research to understand and mitigate impurity formation during the API synthesis process.

Basic Information

Product Name	Imidafenacin Impurity
CAS No.	503599-41-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-(2-Methyl-1H-imidazol-1-yl)-2,2-diphenylbutanenitrile; Imidafenacin Related Compound; Imidafenacin Impurity A; 2,2-Diphenyl-4-(2-methylimidazol-1-yl)butyronitrile; 4-(2-Methylimidazol-1-yl)-2,2-diphenylbutyronitrile; UNII-8V8T6Q5Q4K; 503599-41-5; Butanenitrile, 4-(2-methyl-1H-imidazol-1-yl)-2,2-diphenyl-
EINECS	Contact for details

Quality Control

Our Imidafenacin Impurity is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and stability. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced chromatographic and spectroscopic methods, including HPLC, GC, and NMR. We adhere to ICH guidelines and can support compliance with USP, EP, and cGMP requirements for pharmaceutical reference standards.

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 must be kept in a desiccated environment to maintain stability and purity. Handle and store under an inert atmosphere if specified for long-term storage.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5%

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