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Method for detecting impurities in 1-propylene diethyl phosphate

A technology of diethyl propylene phosphate and a detection method, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., to achieve the effects of strong specificity, high sensitivity, and guaranteed product quality

Pending Publication Date: 2022-07-08
上海峰林生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

The invention solves the bottleneck problem in the research process of fosfomycin sodium genotoxic impurities and solves the detection sensitivity problem of genotoxic impurities

Method used

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  • Method for detecting impurities in 1-propylene diethyl phosphate
  • Method for detecting impurities in 1-propylene diethyl phosphate
  • Method for detecting impurities in 1-propylene diethyl phosphate

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Embodiment Construction

[0034] Some embodiments of the present invention are disclosed below, and those skilled in the art can appropriately improve the process parameters according to the content of this document. The invention can be used for fosfomycin sodium raw material and preparation isomer impurity control, and also can be used for fosfomycin calcium raw material and preparation, fosfomycin tromethamine raw material and preparation isomer impurity control. It should be particularly pointed out that all similar substitutions and modifications are obvious to those skilled in the art, and they are deemed to be included in the present invention. The method and application of the present invention have been described through the preferred embodiments, and it is obvious that relevant persons can make changes or appropriate changes and combinations of the methods and applications described herein without departing from the content, spirit and scope of the present invention to achieve and Apply the t...

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Abstract

The invention discloses a method for detecting impurities in 1-propylene diethyl phosphate, relates to the field of chemical drug analysis, and adopts a triple quadrupole mass spectrometry detector for detection. According to the present invention, the multi-reaction monitoring mode (MRM) of the high performance liquid chromatography-mass spectrometry is adopted to detect the 1-propylene diethyl phosphate, such that the sensitivity is high, the specificity is strong, and the 1-propylene diethyl phosphate in the fosfomycin sodium can be effectively controlled to the toxicological threshold value (TTC), namely 1.5 [mu] g / day.

Description

technical field [0001] The invention relates to the field of chemical drug analysis, in particular to a method for detecting impurities of 1-propylene diethyl phosphate. The invention overcomes the shortcomings of the current research blank of genotoxic impurities of fosfomycin sodium, and develops an impurity detection method, which is used for Product quality control. Background technique [0002] Fosfomycin sodium has bactericidal effect on Gram-positive bacteria and negative bacteria, and has strong antibacterial effect on multi-resistant Staphylococcus, and is a commonly used clinical drug. [0003] In the synthetic route of fosfomycin sodium, 1-propene diethyl phosphate may be produced during the intermediate hydrogenation reaction. The toxicity parameters of 1-propene diethyl phosphate were comprehensively predicted by the ADME / T property prediction software ADMET PredictorTM (version9.5.0.16) of Simulations Plus Company in the United States. This impurity may produc...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/72
CPCG01N30/02G01N30/72
Inventor 郑玉林陈玉双郑明富
Owner 上海峰林生物科技有限公司