Description

Olopatadine Methanol is a key pharmaceutical intermediate and analytical reference standard. This compound is essential for the synthesis and quality control of Olopatadine, a potent antihistamine used in ophthalmic solutions. It is primarily required by pharmaceutical manufacturers, research institutions, and analytical laboratories engaged in drug development and production. The material is supplied to meet the stringent purity requirements of the global pharmaceutical industry.

Application

• Pharmaceutical Intermediate: Critical starting material or intermediate in the synthesis of Olopatadine hydrochloride, the active pharmaceutical ingredient (API) in anti-allergy eye drops.
• Analytical Reference Standard: Used in High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), and Mass Spectrometry (MS) for the identification, assay, and impurity profiling of Olopatadine API and finished drug products.
• Research & Development: Serves as a crucial reagent in medicinal chemistry research for developing new analogs or studying the structure-activity relationship (SAR) of antihistaminic compounds.
• Quality Control & Assurance: Employed in pharmaceutical QC laboratories to validate analytical methods, ensure batch-to-batch consistency, and confirm the identity and purity of raw materials and final products.
• Regulatory Submissions: Provides characterized material necessary for compiling Chemistry, Manufacturing, and Controls (CMC) documentation for regulatory filings with agencies like the FDA, EMA, and PMDA.

Basic Information

Product Name	Olopatadine Methanol
CAS No.	113835-76-0
Molecular Formula	C21H23NO3
Molecular Weight	337.42 g/mol
Synonyms	11-[(Z)-3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid methyl ester; (Z)-11-(3-(Dimethylamino)propylidene)-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid methyl ester; Olopatadine Methyl Ester; KW-4679 Methanol; AL-4943A Methanol
EINECS	Contact for details

Quality Control

Our Olopatadine Methanol is manufactured under strict quality management systems. Each batch is subjected to comprehensive analytical testing, including identification by spectroscopic methods (IR, NMR), purity assay by HPLC, and control of specified impurities. We can supply material that aligns with in-house pharmacopeial standards. A detailed Certificate of Analysis (COA) is provided with each shipment, ensuring full traceability and compliance with your quality requirements.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a dry environment to prevent moisture absorption, which may affect stability and purity.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥98.0%
Related Substances (HPLC)	Total impurities ≤2.0% Any single unknown impurity ≤0.5%
Residual Solvents (GC)	Complies with ICH Q3C guidelines
Loss on Drying	≤1.0%

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