Description

Vilanterol Impurity 23 is a high-purity reference standard used in the analytical characterization and quality control of the active pharmaceutical ingredient (API) Vilanterol. This compound is critical for pharmaceutical manufacturers and analytical laboratories to ensure product safety, efficacy, and regulatory compliance by accurately identifying and quantifying related substances. It is primarily utilized in research and development, method validation, and stability studies within the pharmaceutical industry.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the calibration of analytical instruments and validation of testing methods for Vilanterol API.
• Quality Control & Assurance: Used in HPLC, LC-MS, and other chromatographic analyses to monitor and control impurity profiles during API manufacturing.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity identification and qualification.
• Stability Studies: Employed to track the formation of degradation products in Vilanterol formulations under various storage conditions.
• Method Development: A key component in developing and optimizing analytical procedures for impurity separation and detection.
• Research & Development: Used in synthetic chemistry research to understand impurity formation pathways and to develop purer synthesis routes.

Basic Information

Product Name	Vilanterol Impurity 23
CAS No.	1582675-85-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vilanterol Related Compound 23; Vilanterol EP Impurity 23; Vilanterol USP Impurity 23; GSK642444 Impurity 23; (R)-2-(6-(2-((2,6-Dichlorobenzyl)oxy)ethoxy)hexylamino)-1-(3,5-dihydroxyphenyl)ethanol Impurity; 1-(3,5-Dihydroxyphenyl)-2-{[6-(2-{[2,6-dichlorophenyl)methyl]oxy}ethoxy)hexyl]amino}ethanol Impurity 23
EINECS	Contact for details

Quality Control

Every batch of Vilanterol Impurity 23 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with pharmacopeial standards (e.g., USP, EP) and customer specifications. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity data is provided with each shipment.

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) and must be kept in a desiccated environment to maintain stability and purity.

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 guidelines

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