Description

Vilanterol Impurity 7 Triphenylacetate is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity in the quality control and regulatory compliance of Vilanterol, a long-acting beta2-adrenergic agonist (LABA) used in respiratory medications. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards for method development, validation, and batch release testing. The availability of this well-characterized impurity is fundamental to ensuring drug safety, efficacy, and adherence to stringent global pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Vilanterol Impurity 7 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development & Validation: Critical component for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in compliance with ICH Q2(R1) guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity profiles and ensure drug substance and product specifications are met for regulatory filings (e.g., ANDA, NDA).
• Stability Studies: Employed as a marker in forced degradation and long-term stability studies to understand the degradation pathways of Vilanterol.
• Regulatory Compliance & Documentation: Supports the preparation of regulatory submission documents by providing definitive impurity characterization data required by agencies like the FDA and EMA.
• Research & Process Chemistry: Used in synthetic route development and optimization to identify, track, and minimize the formation of this specific impurity during API manufacturing.

Basic Information

Product Name	Vilanterol Impurity 7 Triphenylacetate
CAS No.	503069-68-9
Molecular Formula	C31H29NO4
Molecular Weight	479.57 g/mol
Synonyms	Vilanterol Triphenylacetate Impurity 7; Vilanterol Related Compound 7; Triphenylacetic acid, ester with vilanterol impurity; GSK642444 Impurity 7; (R)-2-(6-(2-(2,6-Dichlorobenzyloxy)ethoxy)hexylamino)-1-(3,5-dihydroxyphenyl)ethanol triphenylacetate; 1-(3,5-Dihydroxyphenyl)-2-{[6-(2-{[2,6-dichlorophenyl)methyl]oxy}ethoxy)hexyl]amino}ethanol triphenylacetate
EINECS	Contact for details

Quality Control

Our Vilanterol Impurity 7 Triphenylacetate is manufactured under strict quality management systems. Each batch undergoes rigorous analytical testing, including advanced chromatographic and spectroscopic techniques, to ensure identity, purity, and consistency. We provide comprehensive Certificates of Analysis (COA) detailing purity (typically ≥95% by HPLC), impurity profile, and other critical quality attributes. Our quality standards are designed to support compliance with ICH guidelines and relevant pharmacopeial requirements for reference standards.

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 must be kept in a dry environment. For long-term storage, consider desiccant use and storage under inert atmosphere to ensure stability.

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)	Single unspecified impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0% w/w

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