Description

Umeclidinium Bromide Impurity 4 is a specified impurity and reference standard used in the analytical profiling and quality control of the active pharmaceutical ingredient (API) Umeclidinium Bromide. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical formulations by providing a benchmark for identification and quantification during HPLC and related chromatographic analyses. It is an essential material for pharmaceutical R&D laboratories, quality assurance/quality control (QA/QC) departments, and manufacturers involved in the production of respiratory medications.

Application

• Primary use as a certified reference standard (CRS) for analytical method development and validation.
• Critical component in impurity profiling and identification studies for Umeclidinium Bromide API.
• Used in stability-indicating methods to monitor degradation products in drug substance and drug product.
• Essential for pharmacopoeial compliance testing, supporting regulatory filings (e.g., FDA, EMA).
• Serves as a system suitability standard in high-performance liquid chromatography (HPLC) and UPLC assays.
• Supports quality control and batch release processes in GMP manufacturing environments.
• Used in comparability studies for process changes or scale-up activities.

Basic Information

Product Name	Umeclidinium Bromide Impurity 4
CAS No.	869112-31-2
Molecular Formula	C29H34NO2+ • Br-
Molecular Weight	508.49 g/mol
Synonyms	1-[2-(Benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane bromide; GSK573719 Impurity 4; Umeclidinium Related Compound 4; (1R,2R,4S,5S,7s)-9-(2-(Benzyloxy)ethyl)-9-hydroxy-9-diphenyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane bromide; Umeclidinium Bromide EP Impurity D; Umeclidinium Bromide USP Impurity 4
EINECS	Contact for details

Quality Control

Every batch of Umeclidinium Bromide Impurity 4 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Our quality system is designed to meet the stringent requirements for pharmaceutical reference standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results for assay, related substances, and identification. The material is suitable for use in methods validated to ICH Q2(R1) guidelines and supports compliance with pharmacopoeial standards (USP, EP).

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, 15-25°C (59-77°F). The container should be kept in a dry environment to minimize the risk of moisture uptake.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.0%
Purity (HPLC, Area %)	≥ 99.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 0.10% Total impurities: ≤ 1.0%
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.