Description

Olopatadine Impurity 5 is a specified impurity and degradation product of the active pharmaceutical ingredient Olopatadine. This compound is critical for pharmaceutical research and development, serving as a key reference standard for analytical method validation and quality control. It is primarily used by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies to ensure the purity, safety, and efficacy of Olopatadine-based formulations.

Application

• Pharmaceutical Reference Standard: Used as a certified reference material (CRM) for the identification and quantification of impurities in Olopatadine API and finished drug products.
• Analytical Method Development: Essential for developing and validating HPLC, UPLC, and other chromatographic methods for impurity profiling.
• Quality Control & Assurance: Employed in routine QC testing to monitor impurity levels and ensure batch-to-batch consistency complies with ICH Q3A/B guidelines.
• Stability Studies: Used to track the formation of degradation products during forced degradation and long-term stability testing of Olopatadine.
• Regulatory Submissions: Provides necessary impurity data for Drug Master Files (DMFs), Investigational New Drug (IND), and New Drug Application (NDA) submissions to agencies like the FDA and EMA.
• Research & Synthesis: Acts as an intermediate or marker in the research of Olopatadine synthesis pathways and process-related impurities.

Basic Information

Product Name	Olopatadine Impurity 5
CAS No.	55690-18-1
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]oxepin-2-acetic acid; Desmethyl Olopatadine; Olopatadine Related Compound B; Olopatadine Impurity B; KW-4679 Impurity; Allelock Impurity
EINECS	Contact for details

Quality Control

Every batch of Olopatadine Impurity 5 is manufactured and analyzed under strict quality management systems. Our products undergo rigorous identity, purity, and assay testing using validated methods such as HPLC, NMR, and Mass Spectrometry to ensure compliance with pharmacopeial standards. A comprehensive Certificate of Analysis (COA) detailing batch-specific results is provided with each shipment.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. This material is hygroscopic (moisture-sensitive) and must be kept under inert conditions if the container is opened repeatedly to prevent degradation.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (HPLC)	Retention time matches reference standard
Identification (IR)	Spectrum conforms to reference
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Any individual impurity ≤ 0.5%
Total Impurities	≤ 2.0%
Residual Solvents (GC)	Complies with ICH Q3C
Water Content (KF)	≤ 1.0%

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