Description

Vilanterol Impurity 25 is a high-purity chemical reference standard used in the pharmaceutical development and quality control process. This compound is critical for ensuring the safety and efficacy of the active pharmaceutical ingredient (API) Vilanterol by accurately identifying and quantifying related substances. It is an essential tool for analytical chemists and quality assurance professionals working in pharmaceutical R&D and manufacturing. The product is supplied with comprehensive analytical data to support regulatory filings and internal quality standards.

Application

• Pharmaceutical Reference Standard: Primary use as a certified impurity standard for the calibration of analytical equipment (HPLC, LC-MS) in API testing.
• Method Development and Validation: Critical for developing and validating stability-indicating analytical methods for Vilanterol trifenatate.
• Quality Control and Batch Release: Used in the routine testing of Vilanterol API batches to monitor and control impurity levels as per ICH guidelines.
• Regulatory Compliance and Filing: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing definitive impurity identification and characterization data.
• Stability Studies: Employed as a marker to track the formation of degradation products in forced degradation and long-term stability studies of drug substances and products.
• Research and Development: Facilitates the study of impurity formation pathways and the optimization of synthetic processes to minimize related substances.

Basic Information

Product Name	Vilanterol Impurity 25
CAS No.	1027529-99-2
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vilanterol Related Compound 25; Vilanterol EP Impurity 25; Vilanterol USP Impurity 25; Vilanterol Trifenatate Impurity 25; (R)-2-(6-(2-((2,6-Dichlorobenzyl)oxy)ethoxy)hexylamino)-1-(3,5-dihydroxyphenyl)ethanol Impurity; GSK642444 Impurity 25; GW642444 Impurity 25
EINECS	Contact for details

Quality Control

Every batch of Vilanterol Impurity 25 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards, including relevant pharmacopeial monographs (USP, EP). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for identity, purity, and impurity profile as determined by validated chromatographic methods.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. The product is light-sensitive and should be handled under appropriate conditions to maintain stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Conforms
Identification (MS)	Conforms
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unspecified impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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