Description

Vilanterol Impurity 14 is a designated impurity standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Vilanterol. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by serving as a 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 reference material (CRM) for the identification and quantification of Vilanterol Impurity 14 in Vilanterol trifenatate API and related drug products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or LC-MS methods to monitor impurities in accordance with ICH Q3A/B guidelines.
• Quality Control & Batch Release: Employed in routine QC testing to ensure API and finished product batches meet stringent pharmacopeial (e.g., USP, EP) and internal purity specifications.
• Stability Studies: Acts as a critical marker in forced degradation and long-term stability studies to track impurity formation and profile changes over time.
• Regulatory Submissions: Provides necessary impurity characterization data for regulatory filings (e.g., FDA, EMA) to support drug approval and marketing authorization.
• Research & Development: Utilized in synthetic chemistry R&D to understand and control impurity formation pathways during the manufacturing process of Vilanterol.

Basic Information

Product Name	Vilanterol Impurity 14
CAS No.	503068-31-3
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vilanterol Related Compound 14; Vilanterol EP Impurity 14; Vilanterol USP Impurity 14; GSK642444 Impurity 14; (R)-2-(6-(2-((2,6-Dichlorobenzyl)oxy)ethoxy)hexylamino)-1-(3,5-dihydroxyphenyl)ethanol Impurity; 1-(3,5-Dihydroxyphenyl)-2-{[6-(2-{[2,6-dichlorophenyl)methoxy]ethoxy}hexyl)amino]ethanol Impurity 14
EINECS	Contact for details

Quality Control

Our Vilanterol Impurity 14 is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including chromatographic purity assessment and structural confirmation, to ensure it meets the high standards required for pharmaceutical impurity analysis. A comprehensive Certificate of Analysis (COA) is provided, detailing batch-specific results for identity, purity, and assay. We support compliance with ICH, USP, and EP guidelines.

Storage

Preserve in a tightly closed container, protected from light. Store at a controlled room temperature, typically between 15-25°C. The material should be kept in a dry environment to prevent moisture uptake. For long-term storage, consider storing under inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Complies with individual limits
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 2.0%

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