Description

Olopatadine Impurity 1 CAS NO 66801-40-9 is a high-purity reference standard used for analytical and research purposes. This compound is critical for ensuring the quality, safety, and regulatory compliance of the active pharmaceutical ingredient (API) Olopatadine, an antihistamine used in ophthalmic solutions. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and research institutions involved in drug development and quality control. The availability of this well-characterized impurity is essential for method validation, stability studies, and meeting stringent pharmacopeial requirements.

Application

• Pharmaceutical Reference Standard: Serves as a certified impurity standard for the identification and quantification of related substances in Olopatadine API and finished drug products.
• Analytical Method Development & Validation (HPLC/LC-MS): Used as a critical component for developing, optimizing, and validating chromatographic methods to ensure specificity and accuracy.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing to monitor impurity profiles and ensure product consistency meets internal specifications and regulatory guidelines (e.g., ICH Q3A/B).
• Stability Studies: Used to track the formation and levels of this specific degradation product under various stress conditions (e.g., heat, light, humidity) to establish shelf life.
• Regulatory Compliance & Documentation: Essential for preparing regulatory submission dossiers (e.g., for FDA, EMA) that require detailed impurity characterization and control strategies.
• Research & Development (R&D): Utilized in synthetic chemistry research to understand degradation pathways and in the development of robust purification processes for the API.

Basic Information

Product Name	Olopatadine Impurity 1
CAS No.	66801-40-9
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 A; Olopatadine Impurity A; (Z)-Olopatadine; (Z)-Isomer of Olopatadine
EINECS	Contact for details

Quality Control

Our Olopatadine Impurity 1 is manufactured under controlled conditions and undergoes rigorous analytical testing to ensure the highest standards of identity, purity, and consistency. Each batch is supplied with a comprehensive Certificate of Analysis (COA) detailing results from advanced techniques such as HPLC, NMR, and Mass Spectrometry. We adhere to relevant industry and pharmacopeial guidelines to support our clients' needs for regulatory compliance in pharmaceutical development and quality control.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) or as indicated on the label or COA. This product is hygroscopic (moisture-sensitive) and should be handled in a dry environment to prevent degradation. Keep the container tightly sealed after each use.

Specification

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

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