A gas chromatography detection method for 2,5-dimethoxytetrahydrofuran related substances

Through the application of gas chromatography, the problem of difficulty in removing 2,5-dimethoxytetrahydrofuran and its related impurities in the esprazole synthesis process was solved, and effective quality control of esprazole starting materials was achieved, ensuring the quality of the final product.

CN119224184BActive Publication Date: 2025-03-25SHANDONG BESTCOMM PHARMA CO LTD +1
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Patent Information

Application Number
CN202411754707.1
Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
Filing Date
2024-12-03
Publication Date
2025-03-25
Estimated Expiration
2044-12-03

AI Technical Summary

Technical Problem

The prior art is difficult to effectively remove 2,5-dimethoxytetrahydrofuran and its related impurities in the esprazole synthesis process, affecting the quality of the final product esprazole.

Method used

By using gas chromatography, effective separation and detection of 2,5-dimethoxytetrahydrofuran and its related impurities are achieved by selecting appropriate chromatographic columns and temperature programs. The specific steps include taking the resolution solution and the test sample solution for injection, detecting according to specific gas chromatographic conditions, recording the chromatogram, and calculating the detection amount of impurities by peak area normalization.

Benefits of technology

The effective separation of compound (Va), i.e. 2,5-dimethoxytetrahydrofuran (cis-trans isomer mixture) and each impurity is achieved. The detection method is simple to operate, specialized, linear, precision, and high sensitivity. It is suitable for the quality control of esprazole starting materials.

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Abstract

The invention solves the problems existing in the prior art and provides a gas chromatography detection method for 2,5-dimethoxytetrahydrofuran-related substances. The method is simple to operate, has good specificity, linearity and precision, high sensitivity and good method durability, and can be used for the quality control of compound (Va), i.e., 2,5-dimethoxytetrahydrofuran, to meet the process requirements.
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