Description

Vilanterol Impurity 3 Triphenylacetate is a high-purity reference standard critical for pharmaceutical research and development. This compound serves as a key impurity marker in the quality control and validation 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 precise standards to ensure drug safety, efficacy, and regulatory compliance. The availability of this well-characterized impurity supports method development, stability studies, and batch release testing.

Application

• Pharmaceutical Reference Standard: Primary use as a certified reference material (CRM) for the identification and quantification of Vilanterol Impurity 3 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurity profiles in Vilanterol trifenatate synthesis.
• Quality Control & Assurance (QC/QA): Used in-house by API manufacturers and contract research organizations (CROs) to establish specification limits and ensure batch-to-batch consistency.
• Regulatory Compliance and Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA, ICH) by providing data on impurity characterization, qualification, and control strategies.
• Stability Studies: Employed to track the formation and level of this specific impurity under various stress conditions (heat, light, humidity) as per ICH guidelines.
• Research and Development: Used in synthetic chemistry R&D to understand degradation pathways and improve purification processes for Vilanterol.

Basic Information

Product Name	Vilanterol Impurity 3 Triphenylacetate
CAS No.	503070-62-0
Molecular Formula	C33H31NO5
Molecular Weight	521.60 g/mol
Synonyms	Vilanterol Impurity 3; Vilanterol Related Compound 3; Triphenylacetic acid, 6-[(4-{[2-(2-hydroxy-2-phenylethyl)amino]ethyl}phenyl)(hydroxy)methyl]-2-hydroxybenzoate; Vilanterol Trifenatate Impurity 3; GSK642444 Impurity 3; 6-[(4-{[2-(2-Hydroxy-2-phenylethyl)amino]ethyl}phenyl)(hydroxy)methyl]-2-hydroxybenzoic acid triphenylmethyl ester; Vilanterol EP Impurity C
EINECS	Contact for details

Quality Control

Every batch of Vilanterol Impurity 3 Triphenylacetate is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced analytical techniques (HPLC, GC, NMR, MS) to ensure compliance with pharmacopeial standards (USP, EP, ICH). A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results for purity, related substances, residual solvents, and other critical parameters. We support regulatory filings with full traceability and stability data.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C (59-77°F). This compound is hygroscopic (moisture-sensitive); the container must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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