Description

Imidafenacin Impurity (1-(3-Cyano-3,3-Diphenylpropyl)-2-Methyl-1H-Imidazolium Phosphate) is a critical reference standard used in the analytical development and quality control of the active pharmaceutical ingredient, Imidafenacin. This compound is essential for ensuring the purity, safety, and efficacy of pharmaceutical products by enabling the accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of urological medications.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for method development, validation, and routine quality control testing of Imidafenacin API and finished dosage forms.
• Analytical Research & Development: Used in HPLC, LC-MS, and other chromatographic techniques to establish impurity profiles, degradation pathways, and stability-indicating methods.
• Regulatory Compliance & Documentation: Critical for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Pharmacopoeial Testing: Supports testing in compliance with pharmacopoeial monographs (e.g., USP, EP, JP) that specify limits for known and unknown impurities.
• Stability Studies: Employed to monitor the formation of this specific impurity over time under various stress conditions (heat, light, humidity) to determine product shelf-life.
• Process Chemistry Optimization: Used by chemical development scientists to identify and minimize the formation of this impurity during the API synthesis and purification stages.

Basic Information

Product Name	Imidafenacin Impurity (1-(3-Cyano-3,3-Diphenylpropyl)-2-Methyl-1H-Imidazolium Phosphate)
CAS No.	562091-56-9
Molecular Formula	C21H22N3O4P
Molecular Weight	411.39 g/mol
Synonyms	1-(3-Cyano-3,3-diphenylpropyl)-2-methyl-1H-imidazolium phosphate; Imidafenacin Related Compound; Imidafenacin Impurity Standard; 2-Methyl-1-(3-cyano-3,3-diphenylpropyl)imidazolium phosphate; Imidafenacin phosphate impurity; KRP-197/OWI Impurity
EINECS	Contact for details

Quality Control

Every batch of our Imidafenacin Impurity is manufactured and analyzed under strict quality management systems. The product undergoes comprehensive identity confirmation, purity assessment, and impurity profiling using advanced analytical techniques such as HPLC, NMR, and mass spectrometry. A detailed Certificate of Analysis (COA) is provided with each shipment, confirming compliance with in-house specifications tailored for use as a pharmaceutical reference standard.

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 the container is opened frequently.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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