Description

Umeclidinium Impurity 3 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 serving as a benchmark in chromatographic analysis. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of respiratory medications.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Umeclidinium Bromide API batches.
• Analytical Method Development & Validation: Essential for developing, optimizing, and validating HPLC, UPLC, or GC methods for impurity profiling.
• Quality Control & Assurance (QC/QA): Employed in routine quality control testing to monitor impurity levels and ensure compliance with ICH Q3A/B guidelines.
• Regulatory Submissions: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data.
• Stability Studies: Used to track the formation of this specific degradation product under various stress conditions.
• Research & Development: Facilitates process chemistry research aimed at minimizing impurity formation during API synthesis.

Basic Information

Product Name	Umeclidinium Impurity 3
CAS No.	869113-45-1
Molecular Formula	Contact for details
Molecular Weight	Contact for details
Synonyms	Umeclidinium Related Compound 3; Umeclidinium Bromide Impurity 3; 1-[(2R)-2-[[(2R)-2,3-Dihydroxy-2-(4-hydroxy-2-oxo-3,4-dihydro-2H-1-benzopyran-7-yl)ethyl]amino]propyl]-4-[(hydroxydiphenylmethyl)oxy]-1-azoniabicyclo[2.2.2]octane; (1R,4R)-7-[(2R)-2-[[(2R)-2,3-Dihydroxy-2-(4-hydroxy-2-oxochroman-7-yl)ethyl]amino]propyl]-3-oxa-7-azoniatricyclo[3.3.1.1³,⁷]decane 7-olate; GSK573719 Impurity 3
EINECS	Contact for details

Quality Control

Our Umeclidinium Impurity 3 is manufactured under strict quality systems. Each batch undergoes rigorous analytical testing, including identification by spectroscopic methods (NMR, IR, MS) and purity determination by chromatographic techniques (HPLC, UPLC) to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with every shipment.

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 should be handled in a dry environment to prevent degradation.

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)	≥ 95.0%
Related Substances (HPLC)	Total impurities ≤ 5.0% Any individual unknown impurity ≤ 1.0%
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.