Description

Imidafenacin Related Compound 4 is a high-purity chemical reference standard, identified by CAS NO 174266-18-3. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient Imidafenacin through rigorous analytical testing and method validation. It is an essential material for pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories engaged in the development and production of urological medications. Its use is fundamental in meeting stringent global regulatory requirements for drug substance purity and impurity profiling.

Application

• Pharmaceutical Impurity Profiling and Identification: Serves as a certified reference material for the identification and quantification of specific impurities in Imidafenacin drug substance and finished dosage forms.
• Analytical Method Development and Validation: Used as a critical standard to develop, validate, and verify HPLC, UPLC, and GC analytical methods for stability-indicating assays.
• Quality Control and Release Testing: Employed in routine QC laboratories to ensure batch-to-batch consistency and compliance with pharmacopeial specifications (e.g., ICH Q3A/B guidelines).
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies to monitor impurity formation pathways in Imidafenacin formulations.
• Regulatory Submissions: Provides essential data for regulatory filings (e.g., FDA, EMA) to establish impurity limits and justify the control strategy for the drug product.
• Research and Development: Utilized in pharmaceutical R&D to study the synthesis pathway, degradation chemistry, and metabolic pathways of Imidafenacin.

Basic Information

Product Name	Imidafenacin Related Compound 4
CAS No.	174266-18-3
Molecular Formula	C20H21N3O2
Molecular Weight	335.40 g/mol
Synonyms	1-Methyl-2-[(2S)-2-[(1R)-1-phenylethylamino]propyl]-1H-benzimidazol-5-yl acetate; Imidafenacin Impurity; Imidafenacin Related Substance 4; Imidafenacin EP Impurity C; (S)-1-Methyl-2-(2-((R)-1-phenylethylamino)propyl)-1H-benzo[d]imidazol-5-yl acetate; KRP-197/124; A potential metabolite or synthetic intermediate of Imidafenacin
EINECS	Contact for details

Quality Control

Every batch of Imidafenacin Related Compound 4 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with industry standards, including ICH guidelines. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, residual solvents, and other critical parameters. We support audits and can supply documentation for regulatory submissions upon request.

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 under an inert atmosphere, please contact our technical team for specific recommendations.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC)	≥ 97.0%
Related Substances (HPLC)	Individual unknown 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.