Description

Olopatadine Impurity 2 is a specified impurity of the antihistamine drug Olopatadine, used in pharmaceutical quality control and research. This high-purity reference standard is critical for ensuring the safety, efficacy, and regulatory compliance of Olopatadine-based pharmaceutical formulations. It is primarily required by analytical laboratories, pharmaceutical R&D departments, and quality assurance units for method development, validation, and routine batch testing.

Application

• Pharmaceutical Reference Standard: Serves as a certified external standard for the identification and quantification of Olopatadine Impurity 2 in drug substances and finished products.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or LC-MS methods in accordance with ICH guidelines.
• Quality Control & Batch Release: Used in routine QC testing to monitor impurity profiles and ensure drug product specifications are met for every production batch.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) as part of forced degradation and shelf-life studies.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA) to demonstrate control strategies for known and potential impurities.
• Pharmacopoeial Testing: Supports testing against monographs in pharmacopoeias such as USP, EP, or BP where control of related substances is mandated.

Basic Information

Item	Details
Product Name	Olopatadine Impurity 2
CAS No.	56427-76-0
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)-11-[3-(Dimethylamino)propylidene]-6,11-dihydrodibenz[b,e]oxepine-2-acetic acid; Olopatadine Related Compound B; (Z)-Isomer of Olopatadine; Desmethyl Olopatadine Impurity; KW-4679 Impurity
EINECS	Contact for details

Quality Control

Every batch of Olopatadine Impurity 2 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and impurity profile testing using advanced chromatographic (HPLC, GC) and spectroscopic (NMR, MS) techniques to ensure compliance with pharmaceutical reference standard requirements. Comprehensive Certificates of Analysis (COA) detailing batch-specific results are provided and traceable to certified reference materials where applicable.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label. This material is hygroscopic (moisture-sensitive) and must be kept in a dry environment. For long-term storage, consider storing under an inert atmosphere.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to structure
Identification (HPLC)	Retention time matches reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0% w/w
Residue on Ignition	≤ 0.1%

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