Description

Imidafenacin Impurity 8 is a designated impurity standard of the active pharmaceutical ingredient Imidafenacin, a medication used to treat overactive bladder. This high-purity reference material is critical for analytical method development, validation, and quality control in pharmaceutical manufacturing. It is essential for researchers and quality assurance professionals in the pharmaceutical industry who require reliable standards to ensure product safety, efficacy, and regulatory compliance.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the quality control of Imidafenacin API and finished dosage forms.
• Analytical Method Development: Used to develop and optimize chromatographic methods (HPLC, UPLC) for impurity profiling.
• Method Validation: Critical for validating analytical procedures according to ICH Q2(R1) guidelines to ensure specificity, accuracy, and precision.
• Stability Studies: Employed to identify and quantify degradation products formed under various stress conditions.
• Regulatory Submissions: Provides necessary data for drug master files (DMF), investigational new drug (IND) applications, and new drug applications (NDA).
• Pharmacopoeial Testing: Supports testing to meet the specifications of pharmacopoeias such as USP, EP, or JP.
• Research and Development: Used in synthetic chemistry R&D to understand and control impurity formation pathways.

Basic Information

Product Name	Imidafenacin Impurity 8
CAS No.	503598-05-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Imidafenacin Related Compound 8; Imidafenacin Impurity C; 4-(2-Methyl-1H-imidazol-1-yl)-2,2-diphenylbutanenitrile Impurity; (R)-4-(2-Methyl-1H-imidazol-1-yl)-2,2-diphenylbutanenitrile Impurity; 503598-05-8; UNII-9F8I0Q7E7K; 9F8I0Q7E7K
EINECS	Contact for details

Quality Control

Our Imidafenacin Impurity 8 is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation via spectroscopic methods, to ensure it meets the high standards required for pharmaceutical reference materials. 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 at controlled room temperature (15-25°C) or as indicated on the label or COA. Keep the container in a dry, well-ventilated area. Handle and store in accordance with good laboratory practices.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Report individual and total impurities
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0%

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