Description

Umeclidinium Bromide Impurity 9 Dihcl CAS NO 494778-36-8 is a high-purity chemical reference standard, specifically identified as a dihydrochloride salt impurity of the active pharmaceutical ingredient Umeclidinium Bromide. This compound is critically important for analytical method development, validation, and quality control processes in pharmaceutical manufacturing, ensuring the purity and safety of the final drug product. It is primarily required by pharmaceutical R&D laboratories, quality assurance departments, and contract research organizations (CROs) involved in the production and regulatory compliance of respiratory medications.

Application

• Pharmaceutical Reference Standard: Used as a certified impurity standard for the identification and quantification of Umeclidinium Bromide Impurity 9 in active pharmaceutical ingredients (APIs) and finished drug products.
• Analytical Method Development: Essential for developing and optimizing chromatographic methods, such as HPLC and UPLC, for impurity profiling.
• Quality Control & Assurance (QC/QA): Serves as a system suitability standard and for routine batch testing to ensure API purity meets pharmacopeial specifications (e.g., USP, EP).
• Regulatory Compliance & Filings: Supports the preparation of regulatory documentation (e.g., for FDA, EMA) by providing characterized impurity data for drug master files (DMFs) and investigational new drug (IND) applications.
• Stability Studies: Employed to monitor the formation of this specific degradation product under various stress conditions during drug stability testing.
• Research & Development: Used in synthetic chemistry research to study impurity formation pathways and to develop purification processes for the main API.

Basic Information

Product Name	Umeclidinium Bromide Impurity 9 Dihcl
CAS No.	494778-36-8
Molecular Formula	C29H34NO2 • 2HCl
Molecular Weight	524.51 g/mol (Free base: 452.59)
Synonyms	Umeclidinium Impurity 9 Dihydrochloride; 1-[2-(Benzyloxy)ethyl]-4-(hydroxydiphenylmethyl)-1-azoniabicyclo[2.2.2]octane Bromide Impurity 9 Dihydrochloride; (1R,2R,4S,5S,7s)-9-(2-(Benzyloxy)ethyl)-7-hydroxy-9-methyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane Bromide Related Compound; GSK573719 Impurity 9; Umeclidinium Bromide Dihydrochloride Impurity; UNII-Contact for details; Anecto Impurity
EINECS	Contact for details

Quality Control

Every batch of Umeclidinium Bromide Impurity 9 Dihcl is manufactured and analyzed under strict quality management systems. The product undergoes rigorous identity confirmation, purity assay, and impurity profiling using advanced techniques like HPLC, NMR, and mass spectrometry to ensure compliance with pharmaceutical reference standard requirements. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. Our quality protocols are designed to support GMP/GLP environments and regulatory submissions.

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. This material is hygroscopic (moisture-sensitive); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider desiccants or inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time corresponds to reference standard
Identification (NMR)	Spectrum consistent with structure
Purity (HPLC)	≥ 95.0%
Water Content (KF)	≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Heavy Metals	≤ 20 ppm
Specific Rotation	Contact for details

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