Olopatadine Ethyl Ester NEW

Olopatadine Ethyl Ester;113806-03-4

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• 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：C₂₃H₂₇NO₃

• 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%.

We can also customize related analogues and modified peptides including HPLC, MS, 1H-NMR, MS, HPLC, IR, UV, COA, MSDS.
This product is intended for laboratory use only!

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