Keywords

• (Z)-11-(3-dimethylaminopropylidene)-6,11-dihydrodibenz[b,e] oxepin-2-acetic acid ethyl ester
• 113806-03-4
• Olopatadine Ethyl Ester

Quick Details

• ProName: Olopatadine Ethyl Ester 113806-03-4
• CasNo: 113806-03-4
• Molecular Formula: C23H27NO3
• Appearance: White to off white powder
• Application: experiment research
• DeliveryTime: prompt delivery
• PackAge: Food bags, aluminum foil bags
• Port: Shenzhen/hongkong
• ProductionCapacity: 5000 Gram/Year
• Purity: 99%+ HPLC
• Storage: cool and dry
• Transportation: DHL,EMS,TNT,UPS,EMS,by air,by sea;
• LimitNum: 10 Milligram
• Moisture Content: 0.1%
• Impurity: 0.1%

Superiority

We supply over 20000 types of spot impurity reference materials, with sufficient supply and same day delivery to meet customers' urgent needs for replenishment at any time. The company has its own research and development center and laboratory, and the team members have over ten years of experience in developing drug impurity reference standards. Our website www.molcoo.com covers over 98% of cutting-edge generic drug projects, with complete structural formulas that greatly save customers time in impurity structure analysis and inference. All products undergo strict quality control testing and provide relevant information such as COA, H-NMR, C-NMR, MS/GC-MS, HPLC/GC purity, QNMR quantification, TGA thermogravimetric analysis, IR infrared, UV ultraviolet, two-dimensional (COSY, NOESY, HMBC, HMQC), etc. These structural confirmation spectra ensure quality and reliability. Our products have a wide range of categories, fast delivery time, good quality, and low prices, which can quickly solve various customer needs such as replenishment and consistency evaluation.

Details

WhatsAPP: +86 17320513646                      E-mail: anna@molcoo.com

Product Information

• Product Code：O021024
• English Name：Olopatadine Ethyl Ester
• English Alias：(Z)-ethyl 2-(11-(3-(dimethylamino)propylidene)-6,11-dihydrodibenzo[b,e]oxepin-2-yl)acetate
• CAS No.：113806-03-4
• Molecular Formula：C??H??NO?
• Molecular Weight：365.47

Advantages

• High-Purity Reference Standard：Confirmed by HPLC (≥99.0%), NMR, and HRMS, suitable for related substance analysis of Olopatadine.
• Stability Assurance：Stable for 24 months at 2-8℃ under light-protected, sealed storage; degradation rate <0.5% in methanol solution within 1 month.

Applications

• Quality Control：Used for HPLC and LC-MS detection of ethyl ester impurity in Olopatadine API and formulations, controlling impurity content to meet ICH Q3A standards (≤0.1%).
• Process Optimization：Monitors esterification by-product generation during Olopatadine synthesis, reducing ethyl ester impurity formation by adjusting reaction temperature (e.g., 60-70℃) and catalyst dosage (e.g., p-toluenesulfonic acid).
• Method Validation：Serves as a standard for developing impurity detection methods, verifying HPLC specificity, sensitivity (LOD 0.01 ng/mL), and linear range.

Background Description

Olopatadine, a potent H1 receptor antagonist, is used for treating allergic rhinitis and urticaria. Olopatadine Ethyl Ester, a potential esterification by-product during synthesis, may arise from condensation of intermediate carboxylic acid with ethanol. With stricter pharmaceutical regulations, studying such process impurities has become crucial for Olopatadine quality control to ensure drug safety and efficacy.

Research Status

• Detection Technology：UPLC-MS/MS with C18 column (1.7μm) and 0.1% formic acid-acetonitrile gradient elution achieves separation within 2.8 minutes, with LOD of 0.003 ng/mL for trace analysis.
• Formation Mechanism：Originates from acidic esterification of Olopatadine's parent carboxylic acid with ethanol; optimizing reaction time (≤4h) and using excess ethanol reduces content by >75%.
• Safety Evaluation：Preliminary toxicology shows no obvious toxicity to in vitro cells (e.g., Hela cells), but long-term stability testing is required for continuous monitoring. Current standards limit it to ≤0.1%.

WhatsAPP: +86 17320513646
E-mail: anna@molcoo.com

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