Description

Olopatadine Impurity 10 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 research institutions involved in method development, stability studies, and impurity profiling.

Application

• Pharmaceutical Reference Standard for the identification and quantification of impurities in Olopatadine API and finished drug products.
• Analytical Method Development and Validation (HPLC, LC-MS) in quality control laboratories.
• Stability Studies to monitor impurity formation under various stress conditions.
• Regulatory Compliance and Documentation for submissions to agencies like the FDA and EMA.
• Research and Development of Olopatadine synthesis pathways and degradation chemistry.
• Pharmacopoeial Testing to meet standards set by USP, EP, or other pharmacopoeias.

Basic Information

Product Name	Olopatadine Impurity 10 Hbr
CAS No.	4174-83-8
Molecular Formula	C21H23NO3 • HBr
Molecular Weight	418.33 g/mol
Synonyms	11-[(Z)-3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid hydrobromide; Olopatadine Hydrobromide Impurity 10; Olopatadine Related Compound H; (Z)-11-[3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid HBr; KW-4679 Impurity; CAS 4174-83-8
EINECS	Contact for details

Quality Control

Every batch of Olopatadine Impurity 10 Hbr is manufactured and tested under strict quality management systems. Our products undergo rigorous analytical testing, including HPLC, NMR, and MS, to ensure identity, purity, and consistency. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing all test results against established specifications. We support compliance with cGMP, ICH guidelines, and relevant pharmacopoeial standards.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and should be handled in a low-humidity atmosphere to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity ≤ 0.5%; Total impurities ≤ 1.0%

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