Description

Revefenacin Impurity 7 CAS NO 1158777-54-8 is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and efficacy of the active pharmaceutical ingredient (API) Revefenacin, a long-acting muscarinic antagonist used in the treatment of chronic obstructive pulmonary disease (COPD). It is an essential material for pharmaceutical manufacturers, analytical laboratories, and regulatory bodies engaged in method development, validation, and impurity profiling to meet stringent pharmacopeial standards.

Application

• Pharmaceutical Impurity Profiling and Control: Serves as a certified reference material for the identification and quantification of Revefenacin Impurity 7 during drug substance and drug product analysis.
• Analytical Method Development and Validation: Used as a critical standard to establish and validate HPLC, UPLC, or LC-MS methods for impurity detection in compliance with ICH Q3A(R2) and Q3B(R2) guidelines.
• Quality Assurance/Quality Control (QA/QC): Employed in routine batch release testing to monitor and control impurity levels, ensuring final product specifications are met.
• Regulatory Submissions and Compliance: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough understanding and control of the drug's impurity profile.
• Stability Studies: Used as a marker to track impurity formation and degradation pathways of Revefenacin under various stress conditions.
• Research and Development: Facilitates chemical and pharmacological research into the synthesis, metabolism, and safety profile of Revefenacin and related compounds.

Basic Information

Product Name	Revefenacin Impurity 7
CAS No.	1158777-54-8
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	THRX-198321 Impurity; (1R,2R)-N-[(2S)-2-Hydroxy-2-(8-hydroxy-2-oxo-1,2-dihydroquinolin-5-yl)ethyl]-2-methoxy-N-[(1-propylpiperidin-4-yl)methyl]cyclopentanecarboxamide; Revefenacin Related Compound 7; 5-[(2S)-2-[[(1R,2R)-2-Methoxycyclopentanecarbonyl]-[(1-propylpiperidin-4-yl)methyl]amino]-1-hydroxyethyl]-8-hydroxyquinolin-2-one; UNII-6F3Q6J9F5P
EINECS	Contact for details

Quality Control

Every batch of Revefenacin Impurity 7 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing using advanced analytical techniques such as HPLC, GC, MS, and NMR to ensure compliance with industry and pharmacopeial standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, test methods, and acceptance criteria. We support compliance with ICH guidelines and can supply materials suitable for regulatory submissions.

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. This material is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. Keep the container tightly sealed in a cool, dry, and well-ventilated place.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms to reference standard
Identification (IR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residue on Ignition	≤ 0.1%

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