Description

Olopatadine Impurity 11 Hbr is a high-purity chemical reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient Olopatadine. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies for method development, validation, and impurity profiling studies.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference standard for the identification and quantification of specific impurities in Olopatadine Hydrochloride drug substance and finished products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, or other chromatographic methods to monitor impurities during drug manufacturing.
• Quality Control & Assurance (QC/QA): Serves as a benchmark in quality control laboratories to ensure batch-to-batch consistency and compliance with pharmacopeial standards (e.g., USP, EP).
• Stability Studies: Employed in forced degradation and long-term stability studies to track impurity formation in Olopatadine formulations.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., with FDA, EMA) to demonstrate thorough impurity characterization.
• Research & Development: Used in pharmaceutical R&D for studying the degradation pathways and metabolism of Olopatadine.

Basic Information

Product Name	Olopatadine Impurity 11 Hbr
CAS No.	4174-84-9
Molecular Formula	C21H23NO3 • HBr
Molecular Weight	418.33 g/mol
Synonyms	11-Hydroxyolopatadine Hydrobromide; Olopatadine Related Compound HBr; 6,11-Dihydro-11-hydroxy-8-methyl-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-5-one Hydrobromide; (Z)-11-Hydroxyolopatadine HBr; Olopatadine Hydroxy Impurity HBr; PAT-11HBr; 4174-84-9 (CAS)
EINECS	Contact for details

Quality Control

Every batch of Olopatadine Impurity 11 Hbr 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 of pharmaceutical reference standard applications. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing results from HPLC, NMR, and MS analyses.

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 (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%

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