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Method for analyzing genotoxic impurities of fosfomycin tromethamine

A technology of fosfomycin trometamol and analysis method, which is applied in the direction of analysis of materials, separation of materials, resistance to vector-borne diseases, etc., can solve problems such as failure to meet detection limit requirements, and achieve low cost, strong specificity, and specificity strong effect

Active Publication Date: 2020-06-09
上海峰林生物科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

According to the detection requirements, the detection limit is generally about 0.1 of the control limit, so the detection limit should be below 0.05ppm, and the conventional gas phase and liquid phase detection methods cannot meet the detection limit requirements

Method used

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  • Method for analyzing genotoxic impurities of fosfomycin tromethamine
  • Method for analyzing genotoxic impurities of fosfomycin tromethamine
  • Method for analyzing genotoxic impurities of fosfomycin tromethamine

Examples

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Embodiment 1

[0034] Embodiment 1. A kind of analysis method of fosfomycin trometamol genotoxic impurity

[0035]This example mainly describes an analysis method for genotoxic impurities of fosfomycin trometamol. The genotoxic impurities include: diethyl allene phosphate (impurity A), diethyl 1-propenyl phosphate ( Impurity B), diethyl-3-phosphate-3-methyl-propylene oxide (impurity C), or dimethyl-2-phosphate-3-methyl-propylene oxide (impurity D).

[0036] 1. Reference substance

[0037] Diethyl allenyl phosphate (impurity A): batch number: 20190408, content: 94.78%.

[0038] Diethyl 1-propenylphosphate (impurity B): batch number: 20190409, content: 98.79%.

[0039] 3-diethyl phosphate-3 methyl-propylene oxide (impurity C): batch number: 20190916, content: 94.34%.

[0040] 2-Dimethyl phosphate-3-methyl-propylene oxide (impurity D): batch number: 20190918, content: 94.61%.

[0041] 2. Experimental method

[0042] 2.1 Method

[0043] Take 80 mg of fosfomycin trometamol raw material, wei...

Embodiment 2

[0061] Embodiment 2. A kind of analytical method of fosfomycin trometamol genotoxic impurity

[0062] This embodiment mainly describes the analysis method of a kind of fosfomycin trometamol genotoxic impurity, and the difference with embodiment 1 is the following technical parameters:

[0063] (1) Mobile phase A is an aqueous solution containing 10% formic acid;

[0064] (2) The test solution is prepared by the following method: take 80 mg of fosfomycin trometamol crude drug, add it to an aqueous solution containing 95% methanol, vortex to dissolve, shake well, and use it as the test solution.

[0065] (3) The ratio of the numerical value of the weight (mg) of the fosfomycin tromethamine bulk drug to the numerical value of the volume (mL) of the test solution is 90:1;

[0066] (4) The gradient elution rate is 0.85mL / min, and the temperature of the eluted chromatographic column is 32°C;

[0067] (5) The high-performance liquid chromatography-mass spectrometry method includes ...

Embodiment 3

[0069] Embodiment 3. A kind of analysis method of fosfomycin trometamol genotoxic impurity

[0070] This embodiment mainly describes the analysis method of a kind of fosfomycin trometamol genotoxic impurity, and the difference with embodiment 2 is the following technical parameters:

[0071] (1) Mobile phase A is an aqueous solution containing 1% formic acid;

[0072] (2) The test solution is prepared by the following method: take 80 mg of fosfomycin trometamol crude drug, add it to an aqueous solution containing 85% methanol, vortex to dissolve, shake well, and use it as the test solution.

[0073] (3) The ratio of the numerical value of the weight (mg) of the fosfomycin tromethamine bulk drug to the numerical value of the volume (mL) of the test solution is 70:1;

[0074] (4) The gradient elution rate is 0.75mL / min, and the elution column temperature is 28°C.

[0075] After setting the above-mentioned technical parameters, the contriver obtains and embodiment 1 by the dete...

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Abstract

The invention provides a method for analyzing genotoxic impurities of fosfomycin tromethamine. The method comprises the following steps: diluting the fosfomycin tromethamine with a diluent, analyzingimpurities by adopting a high performance liquid chromatography-mass spectrometry method, taking a formic acid solution as a mobile phase A and an acetonitrile solution as a mobile phase B, and carrying out gradient elution. The concentration of formic acid in the formic acid solution is 0.1-10%. The diluent is an aqueous solution containing 85-95% of methanol. The method for analyzing the genotoxic impurities of the fosfomycin tromethamine, provided by the invention, can be used for more efficiently separating and detecting impurities such as diethyl allyldienophosphate and the like, and hasthe advantages of strong specificity, high sensitivity, simplicity, quickness and low cost.

Description

technical field [0001] The invention belongs to the field of drug analysis, in particular to a method for analyzing fosfomycin tromethamine genotoxic impurities. Background technique [0002] Fosfomycin trometamol is an off-white crystalline powder, which is a 1:1 mixture of fosfomycin and 2-amino-2-hydroxymethyl-1,3 propanediol salt, which can directly prevent bacterial cell wall synthesis The role of essential pyruvate transferase, its antibacterial spectrum includes Escherichia coli, Shigella, Pisces citrobacter, Proteus, Serratia, Staphylococcus aureus and Pseudomonas aeruginosa and other microorganisms, can be used to treat corresponding Urinary tract infections and other diseases caused by microorganisms. [0003] Compounds diethyl allenyl phosphate (impurity A), diethyl 1-propenyl phosphate (impurity B), diethyl 3-phosphate-3 methyl-propylene oxide (impurity C), or dimethyl 2-phosphate Ester-3-methyl-propylene oxide (impurity D), etc. are genotoxic impurities remain...

Claims

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Application Information

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IPC IPC(8): G01N30/06G01N30/88
CPCG01N30/06G01N30/88Y02A50/30
Inventor 郑玉林刘丽娟陈玉双
Owner 上海峰林生物科技有限公司
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