Description

Olopatadine Isopropyl Ester Hydrochloride is a key pharmaceutical intermediate in the synthesis of the active pharmaceutical ingredient (API) Olopatadine, a potent antihistamine used in ophthalmic solutions. Its primary value lies in enabling the efficient and high-purity production of the final drug substance, ensuring batch-to-batch consistency and regulatory compliance. This compound is essential for manufacturers in the pharmaceutical industry, particularly those developing and producing anti-allergy medications.

Application

• Primary Intermediate for the synthesis of Olopatadine Hydrochloride API.
• Research & Development of new antihistamine formulations and drug delivery systems.
• Process Chemistry for scaling up and optimizing manufacturing routes for ophthalmic drugs.
• Contract Manufacturing Organizations (CMOs) producing generic or branded ophthalmic solutions.
• Analytical Reference Standard for quality control and method validation in API production.

Basic Information

Product Name	Olopatadine Isopropyl Ester Hydrochloride
CAS No.	1206456-44-1
Molecular Formula	C21H26ClNO3 • HCl
Molecular Weight	404.35 g/mol (as free base: 367.89 g/mol)
Synonyms	11-[(Z)-3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid isopropyl ester hydrochloride; Isopropyl (11Z)-11-[3-(dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepine-2-acetate hydrochloride; Olopatadine Isopropyl Ester HCl; Olopatadine Ester Intermediate; KW-4679 Ester Hydrochloride
EINECS	Contact for details

Quality Control

Our Olopatadine Isopropyl Ester Hydrochloride is manufactured under strict quality management systems. Each batch is tested to ensure it meets stringent specifications for identity, purity, and impurity profiles, suitable for use in pharmaceutical synthesis. Certificates of Analysis (COA) documenting results from advanced analytical techniques like HPLC, NMR, and MS are provided with every shipment to support your regulatory filings and quality assurance processes.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at controlled room temperature (15-25°C). This compound is hygroscopic (moisture-sensitive) and must be kept under dry, inert conditions to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	≥ 98.5%
Related Substances (HPLC)	Total impurities ≤ 1.0% Any single impurity ≤ 0.5%
Water Content (KF)	≤ 0.5%
Residue on Ignition	≤ 0.1%

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