Description

Umeclidinium Bromide Impurity 8 is a high-purity chemical reference standard used for analytical and quality control purposes in pharmaceutical development and manufacturing. This compound is critical for ensuring the safety, efficacy, and regulatory compliance of the active pharmaceutical ingredient (API), Umeclidinium Bromide, by serving as a benchmark for impurity profiling. It is an essential material for analytical chemists, quality assurance professionals, and researchers in the pharmaceutical and contract research organization (CRO) sectors.

Application

• Primary use as a certified reference standard for the identification and quantification of impurities in Umeclidinium Bromide API.
• Critical component in method development and validation for HPLC, UPLC, and LC-MS analytical procedures.
• Essential for conducting stability studies and forced degradation studies to monitor impurity formation over time.
• Used in quality control (QC) laboratories for routine batch release testing of pharmaceutical products.
• Serves as a key material for regulatory submissions (e.g., to FDA, EMA) to establish impurity limits and control strategies.
• Valuable for academic and industrial research into the synthesis, metabolism, and degradation pathways of Umeclidinium Bromide.

Basic Information

Product Name	Umeclidinium Bromide Impurity 8
CAS No.	869113-10-0
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Umeclidinium Related Compound 8; Umeclidinium Bromide EP Impurity 8; Umeclidinium Bromide USP Impurity 8; GSK573719 Impurity 8; (1R,2R,4S,5S,7s)-9-[(2,2-Difluoro-2-(2-thienyl)ethoxy)methyl]-9-azoniabicyclo[3.3.1]nonane Bromide Impurity; Anoro Ellipta Impurity 8; 869113-10-0
EINECS	Contact for details

Quality Control

Every batch of Umeclidinium Bromide Impurity 8 is manufactured and tested under strict quality management systems. Our products undergo rigorous quality testing to ensure compliance with industry standards for pharmaceutical reference materials. Comprehensive Certificates of Analysis (COA) are provided, detailing purity, identity, and impurity profiles as confirmed by advanced chromatographic and spectroscopic methods.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and must be kept in a desiccated environment to maintain stability and purity. Ensure the container is sealed immediately after use.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity: ≤ 1.0% Total impurities: ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
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.