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Method for detecting impurities in propadiene diethyl phosphate

A technology of allene diethyl phosphate and a detection method, which is applied to measurement devices, instruments, scientific instruments, etc., can solve the problems of high difficulty and low control limit of genotoxic impurities, achieve strong specificity and solve the problem of detection sensitivity , Control the effect of product quality

Pending Publication Date: 2022-07-08
上海峰林生物科技有限公司
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  • Abstract
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Problems solved by technology

[0004] The current problem is that there is no corresponding detection method to study and control the genotoxic impurity allenyl phosphate in fosfomycin sodium
[0005] Moreover, genotoxic impurities generally require a lower control limit, which is more difficult than the research on other impurities

Method used

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  • Method for detecting impurities in propadiene diethyl phosphate
  • Method for detecting impurities in propadiene diethyl phosphate
  • Method for detecting impurities in propadiene 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 propadiene diethyl phosphate, which relates to the field of chemical drug analysis, and adopts a triple quadrupole mass spectrometry detector to detect in an ESI positive ion mode and an MRM multi-reaction monitoring mode. According to the present invention, the multi-reaction monitoring mode (MRM) of the high performance liquid chromatography-mass spectrometry is adopted to detect the propadiene diethyl phosphate, such that the sensitivity is high, the specificity is strong, and the propadiene 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 allene diethyl phosphate. Background technique [0002] In the synthetic route of fosfomycin sodium, when the hydrolysis reaction of the intermediate is not complete, after adding ethanol, diethyl allene phosphate may be produced. The toxicity parameters of allene diethyl phosphate were comprehensively predicted by the ADME / T property prediction software ADMETPredictorTM (version 9.5.0.16) of Simulations Plus Company in the United States. This impurity may produce genotoxicity and belong to genotoxic impurities. [0003] Genotoxic impurities (also called genotoxic impurities) usually refer to substances that can cause DNA mutation, chromosome breakage or DNA recombination. Because genotoxic impurities can induce gene mutation and lead to chromosome breakage and rearrangement at very low concentrations, they have potential carcinogenicity...

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Application Information

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IPC IPC(8): G01N30/02G01N30/72
CPCG01N30/02G01N30/72
Inventor 郑玉林陈玉双
Owner 上海峰林生物科技有限公司
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