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Method for analyzing medical organic intermediate impurities

An analytical method and technology for intermediates, which are applied in the field of analysis of impurities in pharmaceutical organic intermediates, can solve the problems of increasing quality control costs and large chromatographic column damage, and achieve the effects of high accuracy, simple and convenient operation, and high analysis efficiency.

Pending Publication Date: 2020-12-25
苏州中科新药篮生物医药科技有限公司
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, due to the problems of chromatographic analysis conditions and chromatographic columns, the accuracy of this analysis method needs to be further improved, and the test process will cause greater damage to the chromatographic column, thereby increasing the cost of quality control

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0045] Embodiment 1 provides a kind of analytical method of pharmaceutical organic intermediate impurity, is characterized in that, comprises the steps:

[0046] Step S1, preparing the sample solution: place the sample of the pharmaceutical organic intermediate in a volumetric flask, dissolve it with a certain solvent to obtain a sample solution of 6 μg / mL;

[0047] Step S2, configuring the reference substance solution: place the pure pharmaceutical organic intermediate in a volumetric flask, and use the same solvent in step S1 to constant volume to obtain the same concentration of the reference substance solution;

[0048] Step S3, HPLC chromatographic analysis: Accurately measure the same volume of the sample solution prepared through step S1 and the reference solution prepared through step S2, inject them into a high performance liquid chromatograph, perform gradient elution, and record the chromatograms respectively;

[0049] Step S4, impurity content statistics: by compar...

Embodiment 2

[0058] Embodiment 2 provides a method for analyzing impurities in pharmaceutical organic intermediates, which is basically the same as in Embodiment 1, except that the gradient elution conditions described in step S3 are: 15min, 90% mobile phase A-70% Mobile phase A, 10% mobile phase B-40% mobile phase B; 33min, 100% mobile phase B; 42min, 0 mobile phase A-95% mobile phase A, 100% mobile phase B-5 % of mobile phase B; the mass spectrometry NMR identification conditions in step S5 are: the accelerating voltage is 19kv, and the delay time is 100ns; the scanning range of LC-MS is 1500m / z, and the scanning range of direct mass spectrometry is extended to 10500m / z.

Embodiment 3

[0060] Embodiment 3 provides a method for analyzing impurities in pharmaceutical organic intermediates, which is basically the same as in Embodiment 1, except that the gradient elution conditions described in step S3 are: 22min, 90% mobile phase A-70% Mobile phase A, 10% mobile phase B-40% mobile phase B; 35min, 100% mobile phase B; 43min, 0 mobile phase A-95% mobile phase A, 100% mobile phase B-5 % of mobile phase B; the mass spectrometry NMR identification conditions in step S5 are: the accelerating voltage is 20kv, and the delay time is 105ns; the scanning range of LC-MS is 3500m / z, and the scanning range of direct mass spectrometry is extended to 11000m / z.

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Abstract

The invention discloses a method for analyzing medical organic intermediate impurities. The method is characterized by comprising the following steps of S1, preparing a sample solution, S2, preparinga reference substance solution, S3, carrying out HPLC chromatographic analysis, S4, carrying out impurity content statistics, and S5, carrying out mass spectrum nuclear magnetic verification. The method for analyzing the medical organic intermediate impurities is higher in accuracy, simpler and more convenient to operate, high in analysis efficiency, capable of effectively controlling the productquality, low in analysis cost and suitable for analysis of most of the medical organic intermediate impurities.

Description

technical field [0001] The invention relates to the technical field of chemical drug analysis methods, in particular to an analysis method for impurities in pharmaceutical organic intermediates. Background technique [0002] Birth, death, sickness, and old age are natural laws. A person's life is full of thorns, and illness is inevitable. Especially in recent years, with the increase of pressure from life and work, the acceleration of the pace of life and the increasingly severe environmental problems, more and more people are suffering from one or the other disease, which causes serious damage to them. It is very important to prescribe the right medicine for these diseases and carry out targeted treatment. [0003] At present, drug therapy is still the main means of disease treatment, and the purity of drug ingredients directly determines the safety and efficacy of drug use. The purity of pharmaceutical ingredients depends on the preparation process of pharmaceutical orga...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/884
Inventor 陈红
Owner 苏州中科新药篮生物医药科技有限公司
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