Description

Olopatadine Usp Rc B CAS NO 173174-07-7 is a high-purity pharmaceutical active ingredient meeting the stringent standards of the United States Pharmacopeia (USP) Reference Standard grade B. This compound is a critical component for ensuring the quality, safety, and efficacy of pharmaceutical products, serving as a benchmark for analytical testing and method validation. It is essential for pharmaceutical manufacturers, analytical laboratories, and research institutions engaged in the development and quality control of antihistamine ophthalmic solutions and related therapeutic agents.

Application

• Pharmaceutical Reference Standard: Primary use as a USP-grade chemical reference substance for identity, assay, and impurity testing in quality control laboratories.
• Analytical Method Development & Validation: Serves as a certified standard for developing and validating HPLC, GC, and other chromatographic methods.
• Active Pharmaceutical Ingredient (API) Manufacturing: Used as a high-purity starting material or intermediate in the synthesis of finished drug products.
• Pharmacopeial Testing & Compliance: Critical for conducting official tests as per USP, EP, or other international pharmacopeia monographs for Olopatadine.
• Research & Development: Supports preclinical and clinical research studies on histamine H1-receptor antagonists.
• Quality Assurance/Quality Control (QA/QC): Provides a reliable benchmark for in-house quality testing, stability studies, and impurity profiling.

Basic Information

Product Name	Olopatadine Usp Rc B
CAS No.	173174-07-7
Molecular Formula	C21H23NO3
Molecular Weight	337.42 g/mol
Synonyms	Olopatadine; (Z)-11-[3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid; KW-4679; AL-4943A; Patanol (brand name related to API); 6,11-Dihydro-11-(3-dimethylaminopropylidene)-dibenz[b,e]oxepin-2-acetic acid
EINECS	Contact for details

Quality Control

Every batch of our Olopatadine Usp Rc B is manufactured and tested to comply with the rigorous specifications of the United States Pharmacopeia (USP). Our quality assurance system ensures identity, purity, strength, and composition. Comprehensive testing includes identification by IR spectroscopy, chromatographic purity assays (HPLC), and control of specified impurities. A Certificate of Analysis (COA) documenting all test results against USP standards is provided with each shipment.

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) and must be kept in a dry environment to maintain stability and potency. The container should be kept tightly sealed when not in use.

Specification

Item	Specification
Appearance	White to off-white crystalline powder
Identification (IR)	Conforms to standard
Identification (HPLC)	Retention time corresponds to reference standard
Assay (HPLC)	98.0% - 102.0% (on anhydrous basis)
Water Content (KF)	≤ 1.0%
Related Substances (HPLC)	Individual impurity: ≤ 0.5% Total impurities: ≤ 2.0%
Residual Solvents (GC)	Complies with USP <467>
Heavy Metals	≤ 20 ppm

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