Description

Vilanterol Impurity 11 is a designated impurity standard used in the pharmaceutical development and quality control of Vilanterol, a long-acting beta2-adrenergic agonist (LABA). This compound is critical for ensuring the purity, safety, and efficacy of the final active pharmaceutical ingredient (API) by serving as a reference marker in analytical testing. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the synthesis, purification, and batch release of Vilanterol and its formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of Vilanterol Impurity 11 in drug substances and products.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating chromatographic methods (e.g., HPLC, UPLC) to monitor impurities.
• Quality Control & Batch Release Testing: Employed in routine QC labs to confirm that Vilanterol API and drug products meet stringent impurity specifications per ICH guidelines.
• Stability Studies: Used to track the formation of this specific impurity under various stress conditions (heat, light, humidity) to establish product shelf-life.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate comprehensive impurity profiling and control strategies.
• Process Chemistry Research: Aids chemists in understanding and optimizing the synthetic pathway to minimize the formation of this impurity.

Basic Information

Product Name	Vilanterol Impurity 11
CAS No.	2762285-55-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Vilanterol Related Compound 11; Vilanterol EP Impurity 11; Vilanterol USP Impurity 11; (R)-Vilanterol Impurity 11; GSK642444 Impurity 11; 1-(2-((6-((2-((2,6-Dichlorobenzyl)oxy)ethoxy)ethyl)amino)-2-hydroxypropyl)-4-(hydroxymethyl)phenol impurity; 2762285-55-0
EINECS	Contact for details

Quality Control

Our Vilanterol Impurity 11 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including HPLC for purity and identity confirmation (IR, MS), to ensure it meets the high standards required for pharmaceutical impurity analysis. Certificates of Analysis (COA) with detailed chromatographic data are provided and traceable to primary reference standards where applicable.

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. The material may be hygroscopic; keep the container tightly sealed in a dry environment.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 5.0% w/w

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