Description

Olopatadine is a potent, selective histamine H1-antagonist widely recognized for its anti-allergic properties. This active pharmaceutical ingredient (API) is crucial for the development of ophthalmic and nasal solutions designed to provide rapid and long-lasting relief from allergic symptoms. It is primarily sought by pharmaceutical manufacturers and R&D institutions in the global life sciences sector. The compound's efficacy and safety profile make it a cornerstone in the formulation of modern allergy treatments.

Application

• Ophthalmic Solutions: Primary active ingredient in prescription and over-the-counter (OTC) eye drops for the treatment of allergic conjunctivitis, including itching, redness, and watering.
• Nasal Sprays: Key component in formulations designed to alleviate symptoms of seasonal and perennial allergic rhinitis.
• Pharmaceutical Intermediates: Serves as a critical building block in the synthesis of more complex drug molecules targeting histamine pathways.
• Research & Development: Used in preclinical and clinical studies to investigate new therapeutic applications for allergic and inflammatory conditions.
• Generic Drug Manufacturing: Essential for the production of generic versions of branded olopatadine-based medications, ensuring cost-effective treatment options.
• Veterinary Pharmaceuticals: Potential application in developing ophthalmic treatments for allergic conditions in companion animals.

Basic Information

Product Name	Olopatadine
CAS No.	113806-05-6
Molecular Formula	C21H23NO3
Molecular Weight	337.42 g/mol
Synonyms	11-[(Z)-3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid; KW-4679; AL-4943A; Patanol® (brand name); Pataday® (brand name); Pazeo® (brand name); (Z)-11-[3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepine-2-acetic acid
EINECS	Contact for details

Quality Control

Our Olopatadine is manufactured under strict quality management systems, targeting compliance with ICH Q7 guidelines and major pharmacopoeial standards such as USP and EP. Every batch undergoes comprehensive analytical testing, including identity confirmation, purity assay, and impurity profiling. A detailed Certificate of Analysis (COA) is provided with each shipment to ensure full traceability and regulatory compliance for our global pharmaceutical partners.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). Due to its hygroscopic nature, the container must be kept tightly sealed in a low-humidity environment to prevent moisture absorption and degradation. Keep away from incompatible materials.

Specification

Item	Specification
Appearance	White to off-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%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 1.5%
Heavy Metals	≤ 20 ppm

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