Description

Umeclidinium Bromide Impurity 3 CAS NO 869185-55-7 is a specified impurity of the active pharmaceutical ingredient (API) Umeclidinium Bromide, a long-acting muscarinic antagonist used in respiratory medicine. This high-purity reference standard is critical for pharmaceutical research, development, and quality control processes to ensure drug safety and efficacy. It is primarily required by analytical laboratories, API manufacturers, and regulatory bodies for method validation, impurity profiling, and compliance with stringent pharmacopeial guidelines.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the qualitative and quantitative analysis of Umeclidinium Bromide drug substance and finished products.
• Analytical Method Development & Validation (HPLC/LC-MS): Essential for developing, validating, and transferring chromatographic methods to accurately detect and quantify this specific impurity.
• Stability Studies & Forced Degradation: Employed in stability-indicating methods to monitor impurity levels in drug products under various stress conditions over time.
• Quality Control & Batch Release Testing: A critical component in the routine QC testing of Umeclidinium Bromide API to ensure batches meet predefined impurity specifications.
• Regulatory Submission & Compliance: Supports regulatory filings (e.g., for FDA, EMA) by providing necessary data on impurity identification, qualification, and control strategies.
• Research on Degradation Pathways: Aids in understanding the chemical degradation pathways of Umeclidinium Bromide, helping to improve formulation and storage conditions.

Basic Information

Product Name	Umeclidinium Bromide Impurity 3
CAS No.	869185-55-7
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 3; Umeclidinium Related Compound 3; (1R,2R,4S,5S,7s)-9-[2-(Benzyloxy)ethyl]-9-azoniabicyclo[3.3.1]nonan-7-yl 2,2-diphenyl-2-hydroxyacetate bromide; Umeclidinium Bromide EP Impurity C; Umeclidinium Bromide USP Related Compound C
EINECS	Contact for details

Quality Control

Our Umeclidinium Bromide Impurity 3 is manufactured under strict quality systems and undergoes rigorous analytical testing to ensure identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques like HPLC, LC-MS, and NMR. We support compliance with relevant pharmacopeial standards (e.g., USP, EP) and ICH Q3A/B guidelines for impurities in new drug substances and products.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature, typically between 15-25°C, in a dry environment. The material is light-sensitive and should be handled accordingly to maintain stability.

Specification

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

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