Description

Imidafenacin Related Compound 10 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 required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method validation, impurity profiling, and quality assurance 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: Serves as a critical component in developing and validating HPLC, UPLC, or GC methods for stability-indicating assays.
• Quality Control (QC) Testing: Employed in routine QC laboratories to monitor impurity levels against established pharmacopeial or internal specifications.
• Stability Studies: Used to track the formation of degradation products in imidafenacin formulations under various stress conditions (e.g., heat, light, humidity).
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) to comply with FDA, EMA, and ICH guidelines.
• Research and Development: Facilitates synthetic route optimization and process chemistry studies by identifying and controlling process-related impurities.

Basic Information

Product Name	Imidafenacin Related Compound 10
CAS No.	212756-27-9
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Imidafenacin Impurity; Imidafenacin Related Substance 10; Imidafenacin EP Impurity; Imidafenacin Process Impurity; 4-(2-Methyl-1H-imidazol-1-yl)-2,2-diphenylbutanamide Related Compound; (R)-4-(2-Methyl-1H-imidazol-1-yl)-2,2-diphenylbutanamide Impurity
EINECS	Contact for details

Quality Control

Our Imidafenacin Related Compound 10 is manufactured and tested under strict quality management systems. Each batch is characterized and qualified using advanced analytical techniques including HPLC, GC-MS, and NMR to ensure identity, purity, and traceability. We provide comprehensive Certificates of Analysis (COA) with detailed chromatographic data, and our quality standards align with ICH Q3A, Q3B, and relevant pharmacopeial guidelines for impurity control.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
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)	≤ 1.0%

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