Product Information

• Product Number: O021025A

• English Name: Olopatadine Impurity 25(Hydrochloride)

• English Alias: (Z)-3-(dibenzo[b,e]oxepin-11(6H)-ylidene)-N-methylpropan-1-amine hydrochloride

• CAS Number: None

• Molecular Formula: C??H??NO·HCl

• Molecular Weight: 301.81

Advantages

• Analyzing the side reaction mechanism of double bond configuration control during olopatadine synthesis to optimize processes for reducing (Z)-isomer impurity generation;

• Serving as a hydrochloride-form reference standard to precisely match the actual state of drugs, improving the accuracy of impurity quantification;

• Helping study the impact of ylidene structures and hydrochlorides on drug stability and toxicological properties to provide a scientific basis for impurity control.

Applications

• Drug Development: Used as an impurity reference standard to identify and quantify Impurity 25 in olopatadine preparations, evaluating the purity of APIs and formulations;

• Quality Control: Acting as a standard substance to validate the sensitivity of detection methods (e.g., HPLC or LC-MS), ensuring this impurity content meets pharmacopoeia requirements during production;

• Stability Studies: Simulating isomerization or salification reaction pathways under drug storage conditions to assist in establishing storage conditions and shelf life.

Background Description

Research Status

• Synthesis Process: Developing high-purity synthesis methods for (Z)-isomer hydrochloride to solve the challenge of chiral separation and obtain single-configuration reference standards;

• Detection Technologies: Using chiral chromatography (e.g., HPLC with chiral columns) or nuclear magnetic resonance (NMR) for highly sensitive detection of cis-trans isomers;

• Toxicological Evaluation: Studying the impact of (Z)-structure and hydrochloride on potential drug toxicity through in vitro cytotoxicity experiments;

• Process Control: Analyzing the influence of parameters such as condensation reaction temperature and catalyst type on isomer generation to optimize conditions for reducing its content.