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: C₁₈H₁₉NO·HCl
Molecular Weight: 301.81
As a hydrochloride impurity of olopatadine, the research advantages of this compound lie in:
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.
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.
Olopatadine is a commonly used antiallergic drug in clinical practice, with both H1 receptor antagonism and mast cell stabilization effects. The double bond in its molecular structure makes it prone to generating cis-trans isomer impurities during synthesis. Olopatadine Impurity 25, as a (Z)-type double bond configuration hydrochloride impurity, may be formed during condensation or salification reactions, and its content directly affects drug quality. Since isomeric impurities may have different biological activities, research on this impurity is an important part of olopatadine quality control.
Current research focuses on:
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.
China
