Description

Vilanterol Impurity 6 Triphenylacetate is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for pharmaceutical quality control, specifically in the development and validation of analytical methods for the active pharmaceutical ingredient Vilanterol. It is primarily utilized by research institutions, analytical laboratories, and pharmaceutical manufacturers engaged in method development, impurity profiling, and regulatory compliance activities.

Application

• Pharmaceutical Impurity Profiling: Serves as a certified reference material for the identification and quantification of process-related impurities in Vilanterol Trifenatate API.
• Analytical Method Development & Validation: Used as a critical standard to develop, optimize, and validate HPLC, UPLC, and LC-MS methods for impurity detection.
• Quality Assurance & Control (QA/QC): Employed in routine batch testing within pharmaceutical QC laboratories to ensure API purity and compliance with ICH guidelines.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs) submitted to agencies like the FDA and EMA.
• Stability Studies: Acts as a marker compound in forced degradation and long-term stability studies of Vilanterol drug products.
• Academic & Contract Research: Supports research in synthetic chemistry, impurity synthesis pathways, and pharmacokinetic studies.

Basic Information

Product Name	Vilanterol Impurity 6 Triphenylacetate
CAS No.	503068-65-3
Molecular Formula	C29H25NO4
Molecular Weight	451.52 g/mol
Synonyms	Vilanterol Related Compound 6; Vilanterol Impurity 6; Triphenylacetic acid, ester with vilanterol impurity; (R)-2-(6-((2-((2,6-Dichlorobenzyl)oxy)ethoxy)ethyl)amino)-2-hydroxypropyl)-4-(hydroxymethyl)phenol triphenylacetate; GSK642444 Impurity 6; Vilanterol Trifenatate Impurity 6
EINECS	Contact for details

Quality Control

Every batch of Vilanterol Impurity 6 Triphenylacetate is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity testing to ensure compliance with ICH Q3A/B, USP, and EP standards for reference materials. Comprehensive analytical data, including HPLC purity, related substance profiles, and structural confirmation (NMR, MS), are documented. A detailed Certificate of Analysis (COA) is provided with each shipment to guarantee traceability and batch-to-batch consistency.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). The product is light-sensitive and should be handled under appropriate conditions to prevent degradation. Keep the container in a dry, cool, and well-ventilated area.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 0.5% w/w

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