Description

Imidafenacin Impurity (n-(3-Carbamoyl-3,3-Diphenylpropyl)-Oxamic Acid) is a high-purity reference standard and a key process-related impurity in the synthesis of the active pharmaceutical ingredient Imidafenacin. This compound is critical for pharmaceutical research, development, and quality control, enabling accurate identification, quantification, and monitoring during drug manufacturing. It is primarily utilized by analytical laboratories, pharmaceutical R&D teams, and quality assurance departments to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the calibration of analytical instruments and validation of testing methods.
• Impurity Profiling & Characterization: Used in method development and validation for the identification and quantification of this specific impurity in Imidafenacin drug substance and finished products.
• Quality Control & Assurance (QC/QA): Essential for routine batch testing in pharmaceutical manufacturing to ensure impurity levels remain within International Council for Harmonisation (ICH) guidelines.
• Stability Studies: Employed as a marker to monitor the degradation pathways and shelf-life stability of Imidafenacin formulations under various storage conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDA) to meet FDA, EMA, and other global health authority requirements.
• Process Chemistry Research: Aids in the optimization of synthetic routes by helping chemists understand and minimize the formation of this impurity during production.

Basic Information

Product Name	Imidafenacin Impurity (n-(3-Carbamoyl-3,3-Diphenylpropyl)-Oxamic Acid)
CAS No.	503598-07-0
Molecular Formula	C19H20N2O4
Molecular Weight	340.38 g/mol
Synonyms	N-(3-Carbamoyl-3,3-diphenylpropyl)oxamic Acid; 2-[[(3-Carbamoyl-3,3-diphenylpropyl)amino]carbonyl]oxyacetic Acid (tautomer); Imidafenacin Related Compound; Imidafenacin Impurity A; Imidafenacin Process Impurity; KRP-197/IMP; Oxamic acid, N-[3-(aminocarbonyl)-3,3-diphenylpropyl]-
EINECS	Contact for details

Quality Control

Every batch of our Imidafenacin Impurity is manufactured and analyzed under strict quality management systems. We provide comprehensive analytical data to support its use as a reference standard, including HPLC purity, identity confirmation (IR, NMR, MS), and detailed impurity profiling. A Certificate of Analysis (COA) is supplied with each product, detailing batch-specific results. Our quality protocols are designed to meet the rigorous standards required for pharmaceutical impurities and reference materials.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The container should be kept in a dry, cool, and well-ventilated area. For long-term storage, consider storing under inert atmosphere to ensure maximum stability.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any individual impurity ≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Water Content (KF)	≤ 1.0% w/w

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