Description

Imidafenacin Impurity 4 is a specified impurity and a key chemical reference standard used in the analytical profiling of the active pharmaceutical ingredient (API) Imidafenacin. This compound is critical for ensuring the quality, safety, and efficacy of the final drug product by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, quality control laboratories, and regulatory bodies involved in the development and production of antimuscarinic medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Imidafenacin API and finished dosage forms.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in pharmaceutical R&D and QC labs.
• Regulatory Compliance & Documentation: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity data for drug master files (DMFs) and new drug applications (NDAs).
• Quality Control & Batch Release Testing: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency of the API.
• Stability Studies: Used to track the formation and growth of this specific impurity during forced degradation and long-term stability studies of the drug substance.
• Pharmacopoeial Testing: May be used to comply with pharmacopoeial monographs (e.g., USP, EP, JP) that specify limits for related substances.

Basic Information

Product Name	Imidafenacin Impurity 4
CAS No.	503598-78-5
Molecular Formula	C20H21N3O2
Molecular Weight	335.40 g/mol
Synonyms	1-Methyl-2-[(4-methyl-1-piperazinyl)methyl]-4-(1H-imidazol-1-yl)-6,7-dihydro-5H-cyclopenta[b]pyridin-5-one; Imidafenacin Related Compound 4; Imidafenacin EP Impurity D; Imidafenacin USP Impurity; KRP-197/OWI Impurity; (5-Oxo-4-(1H-imidazol-1-yl)-6,7-dihydro-5H-cyclopenta[b]pyridin-2-yl)methyl 4-methylpiperazine-1-carboxylate (alternative form); UNII-9V6T2J8Q4M
EINECS	Contact for details

Quality Control

Every batch of Imidafenacin Impurity 4 is manufactured and controlled under a strict quality management system. The product undergoes comprehensive analytical testing, including HPLC purity assay, residual solvent analysis (GC), and structural confirmation (NMR, MS) to ensure identity, purity, and consistency. A detailed Certificate of Analysis (COA) is provided with each shipment, containing batch-specific results. Our quality standards are designed to meet the rigorous requirements of pharmaceutical reference material applications.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

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%
Related Substances (HPLC)	Any individual impurity ≤ 2.0%
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.