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Analysis method for genotoxic impurity 6,8-dichloro ethyl caprylate in lipoic acid

A technology of dichlorooctanoic acid ethyl ester and genotoxicity, which is applied in the direction of analyzing materials, material separation, measuring devices, etc., can solve the problems that the analysis technology has not been reported, and achieve the effect of good detection accuracy

Active Publication Date: 2018-05-04
SHANDONG ANALYSIS & TEST CENT
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  • Abstract
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Problems solved by technology

But there is no report about the analysis technology of 6,8-dichlorooctanoic acid ethyl ester

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  • Analysis method for genotoxic impurity 6,8-dichloro ethyl caprylate in lipoic acid
  • Analysis method for genotoxic impurity 6,8-dichloro ethyl caprylate in lipoic acid
  • Analysis method for genotoxic impurity 6,8-dichloro ethyl caprylate in lipoic acid

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[0026] It should be noted that the following detailed description is exemplary and intended to provide further explanation of the application. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs.

[0027] It should be noted that the terminology used herein is for the purpose of describing specific embodiments only, and is not intended to limit the exemplary embodiments according to the present application. As used herein, unless the context clearly dictates otherwise, the singular is intended to include the plural as well, furthermore, it is to be understood that when the terms "comprising" and / or "including" are used in this specification, it indicates that There are features, steps, operations, devices, components and / or combinations thereof.

[0028] General

[0029] 1. Validation results

[0030]

[0031]

[0032] 2. Chromatograph...

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Abstract

The invention discloses an analysis method for genotoxic impurity 6,8-dichloro ethyl caprylate in lipoic acid. A gas chromatography and mass spectrum coupling technology is adopted to detect the 6,8-dichloro ethyl caprylate in zinc sulfate sample solution; the detection condition of the gas chromatography is that a chromatographic column is DB-WAX 30m*0.25mm*0.25mu m, a stationary phase is polyethylene glycol, and carrier gas is high-purity nitrogen; a column temperature is that an initial temperature is 100 DEG C and is maintained for two minutes, then, the temperature is raised to 230 DEG Cat a rate of 20 DEG C per minute, and the temperature of 230 DEG C is maintained for 5min; a mass spectrum condition that ion source voltage is -70eV, an ion source temperature is 230 DEG C, the temperature of a four-level rod is 150 DEG C, and the temperature of an interface is 280 DEG C. The analysis method has the advantages of high analysis speed and high sensitivity.

Description

Technical field [0001] The invention specifically relates to a method for analyzing the genotoxic impurity 6,8-dichlorooctanoic acid ethyl ester in lipoic acid based on gas chromatography-mass spectrometry technology. technical background [0002] Genotoxic impurities refer to substances that can directly or indirectly damage DNA, cause gene mutations, or have carcinogenic tendencies. Genotoxic impurities are characterized by causing damage to human genetic material at very low concentrations and are mutagenic and carcinogenic, seriously threatening human health during drug use. In recent years, there have been more and more cases in which trace amounts of genotoxic impurity residues were found in marketed drugs, leading to widespread medical accidents and forced recalls by the FDA, causing huge economic losses to pharmaceutical manufacturers. For example, in the 2007 Roche Vilasid tablet incident, due to the serious over-limit of ethyl mesylate in the drug, which caused ab...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 陈相峰刘兰畦
Owner SHANDONG ANALYSIS & TEST CENT
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