Description

Revefenacin Impurity 2 CAS NO 1158699-78-5 is a specified impurity of the active pharmaceutical ingredient Revefenacin, used in the treatment of chronic obstructive pulmonary disease (COPD). This compound is critical for pharmaceutical research and development, serving as a certified reference standard for analytical method development, validation, and quality control. It is essential for manufacturers and analytical laboratories focused on ensuring the purity, safety, and regulatory compliance of Revefenacin-based drug products.

Application

• Primary use as a certified reference standard for the identification and quantification of Revefenacin Impurity 2 in drug substances and products.
• Critical component in analytical method development and validation (e.g., HPLC, UPLC, GC) for pharmaceutical quality control laboratories.
• Used in stability studies and impurity profiling to monitor degradation pathways of Revefenacin.
• Essential material for regulatory submissions (e.g., FDA, EMA) to establish impurity limits and specifications.
• Supports research and development of synthetic routes and purification processes for Revefenacin.
• Utilized in pharmacopoeial testing to ensure compliance with monographs from USP, EP, or other international standards.

Basic Information

Product Name	Revefenacin Impurity 2
CAS No.	1158699-78-5
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Revefenacin Related Compound 2; (1R,2R,4S)-2-Hydroxy-7-[(1R)-1-hydroxy-2-[[(2R)-2-(4-methoxyphenyl)-1-methylethyl]amino]ethyl]-4-(phenylsulfonyl)-2,3-dihydro-1H-inden-1-yl 2,2-dimethylpropanoate; TD-4208 Impurity 2; Revefenacin EP Impurity B; Revefenacin USP Impurity; UNII-Contact for details
EINECS	Contact for details

Quality Control

Our Revefenacin Impurity 2 is manufactured under strict quality systems suitable for use as a reference standard. Each batch undergoes rigorous analytical testing, including chromatographic purity and spectroscopic identification, to ensure identity, potency, and purity. Certificates of Analysis (COA) are provided, detailing comprehensive test results against established specifications. We support compliance with ICH guidelines and relevant pharmacopoeial standards (USP, EP).

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); the container must be kept tightly sealed 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 structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C

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