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Method for determining residual methyl alcohol, ethyl alcohol, dichloromethane and ethyl acetate in clarithromycin

A technology of clarithromycin and dichloromethane, which is applied in the field of biological raw material detection, can solve the problem of not measuring clarithromycin, etc., and achieve the effects of improving capacity, large injection volume and prolonging life.

Inactive Publication Date: 2016-05-18
NINGXIA QIYUAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0003] Because there is no report on the determination of residual methanol, ethanol, dichloromethane, and ethyl acetate solvents in clarithromycin in domestic and foreign literature

Method used

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  • Method for determining residual methyl alcohol, ethyl alcohol, dichloromethane and ethyl acetate in clarithromycin
  • Method for determining residual methyl alcohol, ethyl alcohol, dichloromethane and ethyl acetate in clarithromycin
  • Method for determining residual methyl alcohol, ethyl alcohol, dichloromethane and ethyl acetate in clarithromycin

Examples

Experimental program
Comparison scheme
Effect test

Embodiment example 1

[0010] Solution preparation:

[0011] Internal standard stock solution: Accurately weigh 2.0 g of n-butanol, place it in a 50 ml volumetric flask filled with 10 ml of 1-methyl-2-pyrrolidone, dilute to the mark with 1-methyl-2-pyrrolidone, and shake well.

[0012] Internal standard solution: Accurately draw 5.0ml of internal standard stock solution, put it in a 200ml volumetric flask, and dilute to the mark with 1-methyl-2-pyrrolidone.

[0013] Control solution: Accurately weigh 0.4g of dichloromethane, 1.2g of methanol, 2.0g of ethanol, and 2.0g of ethyl acetate into a 50ml volumetric flask filled with 10ml of 1-methyl-2-pyrrolidone in advance, and use 1-methyl-2 - Dilute pyrrolidone to volume and shake well. Precisely draw 5.0ml into a 200ml volumetric flask, then precisely draw 5.0ml of internal standard stock solution, dilute to the mark with 1-methyl-2-pyrrolidone, and shake well.

[0014] Test solution: Accurately weigh 1.0 g of the test product, put it in a 20 ml heads...

Embodiment example 2

[0027] Solution preparation:

[0028] Internal standard stock solution: Accurately weigh 2.0 g of n-butanol, place it in a 50 ml volumetric flask filled with 10 ml of 1-methyl-2-pyrrolidone, dilute to the mark with 1-methyl-2-pyrrolidone, and shake well.

[0029] Internal standard solution: Accurately draw 5.0ml of internal standard stock solution, put it in a 200ml volumetric flask, and dilute to the mark with 1-methyl-2-pyrrolidone.

[0030] Control solution: Accurately weigh 0.4g of dichloromethane, 1.2g of methanol, 2.0g of ethanol, and 2.0g of ethyl acetate into a 50ml volumetric flask filled with 10ml of 1-methyl-2-pyrrolidone in advance, and use 1-methyl-2 - Dilute pyrrolidone to volume and shake well. Precisely draw 5.0ml into a 200ml volumetric flask, then precisely draw 5.0ml of internal standard stock solution, dilute to the mark with 1-methyl-2-pyrrolidone, and shake well.

[0031] Test solution: Accurately weigh 1.0 g of the test product, put it in a 20 ml heads...

Embodiment example 3

[0044] Solution preparation:

[0045] Internal standard stock solution: Accurately weigh 2.0 g of n-butanol, place it in a 50 ml volumetric flask filled with 10 ml of 1-methyl-2-pyrrolidone, dilute to the mark with 1-methyl-2-pyrrolidone, and shake well.

[0046] Internal standard solution: Accurately draw 5.0ml of internal standard stock solution, put it in a 200ml volumetric flask, and dilute to the mark with 1-methyl-2-pyrrolidone.

[0047] Control solution: Accurately weigh 0.4g of dichloromethane, 1.2g of methanol, 2.0g of ethanol, and 2.0g of ethyl acetate into a 50ml volumetric flask filled with 10ml of 1-methyl-2-pyrrolidone in advance, and use 1-methyl-2 - Dilute pyrrolidone to volume and shake well. Precisely draw 5.0ml into a 200ml volumetric flask, then precisely draw 5.0ml of internal standard stock solution, dilute to the mark with 1-methyl-2-pyrrolidone, and shake well.

[0048] Test solution: Accurately weigh 1.0 g of the test product, put it in a 20 ml heads...

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Abstract

The invention relates to a method for determining residual methyl alcohol, ethyl alcohol, dichloromethane and ethyl acetate in clarithromycin. Headspace gas chromatography is adopted in the method, the service life of chromatographic columns can be prolonged, residual solvent methyl alcohol, ethyl alcohol, dichloromethane and ethyl acetate in clarithromycin can be accurately determined, detection results are accurate and reliable, and the method is high in specificity.

Description

technical field [0001] The invention belongs to the technical field of biological raw material detection, in particular to a method for determining residual methanol, ethanol, dichloromethane and ethyl acetate in clarithromycin. Background technique [0002] Solvents used in the production process of clarithromycin include methanol, ethanol, dichloromethane, ethyl acetate and other solvents. The production process of clarithromycin cannot completely remove the above solvents. In order to control the quality of clarithromycin and ensure the safety of patients, It is necessary to determine the residual methanol, ethanol, dichloromethane, ethyl acetate and other solvents in clarithromycin. [0003] Because there is no report on the determination of residual methanol, ethanol, dichloromethane, and ethyl acetate solvents in clarithromycin in domestic and foreign literature. The present invention detects residual solvents such as methanol, ethanol, dichloromethane, ethyl acetate ...

Claims

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Application Information

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IPC IPC(8): G01N30/02
Inventor 王咏梅邹学峰孙瑞君
Owner NINGXIA QIYUAN PHARMA
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