Description

2- Hydroxyl Olopatadine Hydrochloride Impurity is a high-purity chemical reference standard critical for pharmaceutical research and development. This compound serves as a specified impurity for the quality control and analytical validation of Olopatadine Hydrochloride, an important antihistamine medication. It is essential for analytical chemists and quality assurance professionals in the pharmaceutical industry who require reliable standards to ensure drug purity, safety, and regulatory compliance.

Application

• Pharmaceutical Impurity Profiling: Used as a certified reference material (CRM) for the identification and quantification of related substances in Olopatadine Hydrochloride active pharmaceutical ingredient (API) and finished drug products.
• Analytical Method Development and Validation: Critical for developing, optimizing, and validating stability-indicating HPLC, UPLC, or LC-MS methods in accordance with ICH guidelines.
• Quality Control & Assurance (QC/QA): Employed in routine batch release testing to monitor impurity levels and ensure compliance with pharmacopeial specifications (e.g., USP, EP).
• Stability Studies: Used to track the formation of this specific degradant during forced degradation and long-term stability studies of Olopatadine formulations.
• Regulatory Submissions: Provides essential data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Research & Development: Supports synthetic route optimization and impurity fate and tolerance studies during API process development.

Basic Information

Product Name	2- Hydroxyl Olopatadine Hydrochloride Impurity
CAS No.	1331822-32-2
Molecular Formula	C21H23NO4 • HCl
Molecular Weight	389.88 g/mol (Free base: 353.42 g/mol)
Synonyms	Olopatadine Hydrochloride Impurity H; Olopatadine Related Compound H; 11-[(Z)-3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic Acid Hydrochloride; 2-Carboxy Olopatadine; 2-Hydroxy Olopatadine HCl; 2-COOH Olopatadine Impurity; (11Z)-11-[3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepine-2-acetic Acid Hydrochloride
EINECS	Contact for details

Quality Control

Every batch of 2- Hydroxyl Olopatadine Hydrochloride Impurity is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using advanced chromatographic and spectroscopic techniques (HPLC, GC, NMR, MS) to ensure compliance with industry standards. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results. We support compliance with cGMP, ICH Q3A/B, and relevant pharmacopeial guidelines.

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); the container must be kept tightly sealed in a dry environment to prevent degradation. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (HPLC)	Conforms
Identification (IR)	Conforms to reference spectrum
Purity (HPLC)	≥ 98.0%
Assay (on dried basis)	97.0% - 102.0%
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Single Unknown Impurity (HPLC)	≤ 0.5%
Total Impurities (HPLC)	≤ 2.0%

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