Description

Imidafenacin Related Compound 2 (n-(3-Carbamoyl-3,3-Diphenylpropyl)-Oxamide) is a high-purity reference standard and pharmaceutical intermediate critical for quality control and research applications. This compound is essential for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient Imidafenacin, a medication used to treat overactive bladder. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in drug development and regulatory compliance. The availability of this well-characterized related compound is fundamental for method validation, impurity profiling, and meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the quantitative and qualitative analysis of Imidafenacin in drug substances and products.
• Impurity Profiling and Control: Critical for identifying, quantifying, and monitoring this specific impurity during the manufacturing and stability testing of Imidafenacin API.
• Analytical Method Development and Validation: Serves as a key component in developing and validating HPLC, UPLC, or LC-MS methods for impurity detection.
• Pharmacopeial Compliance: Supports compliance with regulatory guidelines from agencies like the FDA, EMA, and ICH, which require the identification and control of known impurities.
• Process Chemistry Research: Used in studies to understand the formation and fate of this related compound during synthetic route development and optimization.
• Stability Studies: Employed as a marker to assess the degradation pathways and shelf-life of Imidafenacin formulations under various storage conditions.

Basic Information

Product Name	Imidafenacin Related Compound 2
CAS No.	503598-17-2
Molecular Formula	C24H23N3O3
Molecular Weight	401.46 g/mol
Synonyms	n-(3-Carbamoyl-3,3-Diphenylpropyl)-Oxamide; 2-[(3-Carbamoyl-3,3-diphenylpropyl)amino]-2-oxoacetamide; Imidafenacin Impurity; Imidafenacin Related Substance 2; Imidafenacin EP Impurity B; KRP-197/IM-1 Related Compound; Oxamide, N-(3-carbamoyl-3,3-diphenylpropyl)-
EINECS	Contact for details

Quality Control

Every batch of Imidafenacin Related Compound 2 is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC purity assay and identity confirmation (IR, MS), to ensure compliance with high-grade reference standard specifications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, impurities, and other critical parameters. We support compliance with ICH Q3A/B guidelines and can supply material suitable for use in regulated environments.

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 compound is hygroscopic (moisture-sensitive); therefore, the container must be kept tightly sealed in a dry environment to prevent absorption of moisture. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Single unknown impurity ≤ 0.5% Total impurities ≤ 1.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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