Description

Olopatadine Impurity 13 is a specified impurity of the antihistamine drug Olopatadine, used in pharmaceutical research and development. This compound is critical for analytical method development, stability studies, and ensuring the quality and safety of the final drug product. It is primarily required by pharmaceutical manufacturers, contract research organizations (CROs), and quality control laboratories for compliance with stringent regulatory standards.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Olopatadine drug substance and finished products.
• Analytical Method Development and Validation: Essential for developing and validating HPLC, UPLC, or GC methods to monitor impurity profiles.
• Stability Studies: Employed in forced degradation and long-term stability testing to understand the degradation pathways of Olopatadine.
• Quality Control & Assurance: Serves as a system suitability standard in routine QC testing to ensure batch-to-batch consistency and compliance with ICH guidelines.
• Regulatory Submissions: Provides necessary data for drug master files (DMFs), investigational new drug (IND) applications, and new drug applications (NDAs).
• Process Chemistry Research: Used to study and optimize synthesis pathways to minimize the formation of this specific impurity.

Basic Information

Product Name	Olopatadine Impurity 13
CAS No.	55453-90-2
Molecular Formula	C21H23NO3
Molecular Weight	337.42 g/mol
Synonyms	11-[(Z)-3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepin-2-acetic acid; (Z)-2-[11-[3-(Dimethylamino)propylidene]-6H-dibenzo[b,e]oxepin-2-yl]acetic acid; Olopatadine Related Compound; Olopatadine EP Impurity; Olopatadine USP Impurity; (Z)-Isomer of Olopatadine; UNII-9K5L8P8I4F
EINECS	Contact for details

Quality Control

Every batch of Olopatadine Impurity 13 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous testing to ensure identity, purity, and consistency, aligning with current pharmacopeial standards (USP/EP/ICH). A comprehensive Certificate of Analysis (COA) detailing results for assay, related substances, residual solvents, and other critical parameters 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 desiccated environment to maintain stability and purity.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residual Solvents (GC)	Complies with ICH Q3C

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