Description

Imidafenacin Related Compound 11 is a high-purity chemical reference standard used in pharmaceutical research and development. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient, Imidafenacin, through rigorous analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and quality control processes.

Application

• Pharmaceutical Impurity Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of specific impurities in Imidafenacin drug substance and finished products.
• Analytical Method Development and Validation: Essential for developing and validating chromatographic methods, such as HPLC and UPLC, to meet ICH Q2(R1) guidelines.
• Quality Control (QC) Testing: Serves as a system suitability standard in routine QC labs to monitor the performance of analytical procedures for Imidafenacin batches.
• Stability Studies: Employed in forced degradation and long-term stability studies to track the formation of this related compound under various stress conditions.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., FDA, EMA) to establish impurity thresholds and justify specifications.
• Research and Development: Used in synthetic chemistry R&D to understand degradation pathways and optimize manufacturing processes for higher purity.

Basic Information

Product Name	Imidafenacin Related Compound 11
CAS No.	170105-09-6
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	4-(2-Methyl-1H-imidazol-1-yl)-2,2-diphenylbutanamide (IUPAC); Imidafenacin Impurity; Imidafenacin Related Substance 11; Imidafenacin Degradation Product; KRP-197/OWI Related Compound; (R)-4-(2-Methyl-1H-imidazol-1-yl)-2,2-diphenylbutanamide; Potential stereoisomer or synthetic intermediate of Imidafenacin.
EINECS	Contact for details

Quality Control

Every batch of Imidafenacin Related Compound 11 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced techniques like HPLC, GC, and NMR to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (typically 15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

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 unknown impurity ≤ 0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0%

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