Description

Vilanterol Impurity 22 (Vilanterol-D4 Triphenylacetate) is a deuterated impurity standard used for the analytical profiling and quality control of the active pharmaceutical ingredient, Vilanterol. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a key reference marker in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and quality assurance of respiratory medications.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of related substances in Vilanterol Trifenatate API and its drug products.
• Analytical Method Development & Validation: Essential for developing, calibrating, and validating HPLC, UPLC, and LC-MS/MS methods in compliance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Provides a benchmark for routine batch testing to ensure API and finished product purity meets pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Employed to monitor the formation of degradation products in Vilanterol formulations under various stress conditions.
• Regulatory Submissions: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary impurity characterization data for drug master files (DMFs) and new drug applications (NDAs).
• Research & Development: Facilitates impurity profiling and route scouting during the synthetic process development of Vilanterol.

Basic Information

Product Name	Vilanterol Impurity 22 (Vilanterol-D4 Triphenylacetate)
CAS No.	2021249-10-3
Molecular Formula	C33H34D4F3NO5
Molecular Weight	609.68 g/mol
Synonyms	Vilanterol D4 Triphenylacetate; Vilanterol Impurity D4; Vilanterol-d4 Triphenylacetate Impurity; Triphenylacetic acid, 4-[(1R)-2-[(6-[(2-[(2,6-dichlorobenzyl)oxy]ethoxy)hexyl]amino]-1-hydroxyethyl]-2-(hydroxymethyl)phenyl ester-d4; GSK642444-d4 Triphenylacetate; 1-(2-((6-(2-(2,6-Dichlorobenzyloxy)ethoxy)hexyl)amino)-1-(hydroxymethyl)-2-(4-(hydroxymethyl)-4H-1,2,4-triazol-3-yl)phenyl)ethyl 2,2,2-triphenylacetate-d4
EINECS	Contact for details

Quality Control

Every batch of Vilanterol Impurity 22 is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity, purity, and assay testing using advanced analytical techniques such as NMR, HPLC, and Mass Spectrometry to ensure compliance with high-purity reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results, chromatographic purity, and structural confirmation data.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider desiccation and storage under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (NMR)	Conforms to structure
Purity (HPLC)	≥ 95.0%
Chemical Purity (Titration)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH limits
Isotopic Enrichment (MS)	≥ 98 atom % D

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