Description

Olopatadine Hydrochloride is a potent, selective histamine H1-receptor antagonist and mast cell stabilizer. This active pharmaceutical ingredient (API) is critical for its superior efficacy in managing allergic inflammatory responses. It is primarily required by pharmaceutical manufacturers for the formulation of ophthalmic solutions and nasal sprays designed to treat allergic conjunctivitis and allergic rhinitis.

Application

• Ophthalmic Solutions: Primary API in prescription and over-the-counter (OTC) eye drops for the relief of itchy, red eyes caused by seasonal allergies.
• Nasal Sprays: Key ingredient in intranasal formulations for the treatment of symptoms associated with seasonal and perennial allergic rhinitis.
• Pharmaceutical R&D: Used in research and development of new anti-allergy medications and combination therapies.
• Generic Drug Manufacturing: Serves as the core component for producing generic versions of branded antihistamine medications.
• Veterinary Pharmaceuticals: Potential application in developing ophthalmic treatments for allergic conditions in animals.

Basic Information

Product Name	Olopatadine Hydrochloride
CAS No.	140462-76-6
Molecular Formula	C21H23NO3•HCl
Molecular Weight	373.87 g/mol (as hydrochloride salt)
Synonyms	Olopatadine HCl; 11-[(Z)-3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid hydrochloride; KW-4679; AL-4943A; Patanol (as formulated drug); Pataday (as formulated drug); Pazeo (as formulated drug)
EINECS	Contact for details

Quality Control

Our Olopatadine Hydrochloride is manufactured under strict quality management systems. We provide material that meets or exceeds relevant pharmacopeial standards, including USP and EP monographs where applicable. Every batch is supported by a comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profiles to ensure regulatory compliance and batch-to-batch consistency for our pharmaceutical partners.

Storage

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

Specification

Item	Specification
Appearance	White to almost white crystalline powder
Identification (IR)	Conforms to reference standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Residue on Ignition	≤ 0.1%
Heavy Metals	≤ 20 ppm
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Specific Rotation	Contact for details

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