Description

Olopatadine Impurity 9 is a designated pharmaceutical reference standard used for analytical and quality control purposes. This compound is critical for ensuring the purity, safety, and efficacy of the active pharmaceutical ingredient (API) Olopatadine, an antihistamine used in ophthalmic solutions. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in drug development and compliance testing. The precise characterization of this impurity is essential for meeting stringent pharmacopeial standards.

Application

• Pharmaceutical Reference Standard: Serves as a certified standard for the identification and quantification of Olopatadine Impurity 9 in API and finished drug products.
• Method Development and Validation: Used in developing and validating analytical methods, particularly High-Performance Liquid Chromatography (HPLC) and related techniques.
• Quality Control & Assurance (QC/QA): Employed in routine batch testing of Olopatadine to monitor and control impurity profiles as per ICH guidelines.
• Regulatory Compliance and Filing: Essential for preparing regulatory submission documents (e.g., for FDA, EMA) that require detailed impurity characterization.
• Stability Studies: Used as a marker in forced degradation and long-term stability studies of Olopatadine formulations.
• Research and Development (R&D): Supports process chemistry research to understand and minimize impurity formation during API synthesis.

Basic Information

Product Name	Olopatadine Impurity 9
CAS No.	680579-52-6
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 Process Impurity; Olopatadine Degradant
EINECS	Contact for details

Quality Control

Every batch of Olopatadine Impurity 9 is manufactured and analyzed under strict quality systems. Our products undergo rigorous quality testing, including advanced chromatographic and spectroscopic techniques, to ensure compliance with industry standards for pharmaceutical reference materials. A comprehensive Certificate of Analysis (COA) detailing purity, identity, and impurity profile is provided with each shipment and is available upon request.

Storage

Preserve in a tightly closed container, protected from light. Store at controlled room temperature (15-25°C) in a dry environment. For long-term storage, consider storing under inert atmosphere to ensure stability.

Specification

Item	Specification
Appearance	White to off-white solid
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time matches reference standard
Purity (HPLC)	≥ 95.0%
Related Substances (HPLC)	Individual unknown impurity ≤ 1.0% Total impurities ≤ 5.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

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