Method for measuring residual solvent in bulk drug mifepristone

A technology for mifepristone and residual solvent is applied in the field of determination of residual solvent in raw material mifepristone, which can solve problems such as hidden dangers of drug safety, and achieve the effects of high sensitivity, quick and simple operation, and improved safety.

Active Publication Date: 2014-07-16
SHANGHAI NEW HUALIAN PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0009] If the limit inspection of solvent residues in medicines is not

Method used

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  • Method for measuring residual solvent in bulk drug mifepristone
  • Method for measuring residual solvent in bulk drug mifepristone
  • Method for measuring residual solvent in bulk drug mifepristone

Examples

Experimental program
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Embodiment 1

[0050] The mensuration of residual solvent in the bulk drug mifepristone of embodiment 1

[0051] (1) Analytical method: headspace gas chromatography.

[0052] Chromatography system:

[0053] Chromatographic column: Agilent DB-624 elastic quartz capillary column (30m×0.53mm×3μm), FID detector.

[0054] Chromatographic parameters:

[0055] Chromatographic separation parameters: carrier gas: nitrogen; carrier gas flow rate: 3.0mL / min; split ratio: 10:1;

[0056] Detector temperature: 250°C; Injection port temperature: 200°C;

[0057] Column temperature: the initial temperature is 45°C, keep for 10 minutes, increase the temperature to 150°C at a rate of 15°C / min, and keep for 3 minutes.

[0058] Headspace detection parameters: heating box: 105°C; quantitative loop: 115°C; transfer line: 125°C;

[0059] GC cycle time: 25min; injection time: 1min;

[0060] Sample balance time: 20min; pressure balance time: 0.2min.

[0061] (2) Solution preparation:

[0062] 1. Reference sub...

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Abstract

The invention discloses a method for measuring residual solvent in bulk drug mifepristone, which is characterized in that a gas chromatograph method is established, the chromatogram of measured standard substance solutions of tetrahydrofuran, ethanol, isopropyl ether, ethyl acetate, dichloromethane, pyridine, acetonitrile and benzene can be compared with chromatogram of a bulk drug mifepristone tested object solution, and then calculated to complete the detection method of the residual solvent in the bulk drug mifepristone. The measuring method has the advantages of rapid and simple operation, high sensitivity, good repeatability and accurate result, solvents of residual tetrahydrofuran, ethanol, isopropyl ether, ethyl acetate, dichloromethane, pyridine, acetonitrile and benzene in the bulk drug mifepristone can be detected in a quantification mode, the method provides a good reference for controlling the residue of an organic solvent in a bulk drug mifepristone production technology, ensures the quality of the mifepristone bulk drug, increases the security of clinical medication, and provides a method basis for increasing the quality standard of the mifepristone bulk drug.

Description

technical field [0001] The invention relates to a method for determining the residual solvent in a steroidal antiprogestin crude drug, in particular to a method for determining the residual solvent in the crude drug mifepristone. Background technique [0002] Mifepristone is a variety recorded in the 2005 edition of the Chinese Pharmacopoeia. It is an anti-early pregnancy drug developed in recent years. It has the functions of terminating early pregnancy, anti-implantation, inducing menstruation and promoting uterine contraction. The drug needs to use organic solvents such as ethanol, tetrahydrofuran, isopropyl ether, ethyl acetate, acetonitrile, benzene, dichloromethane and pyridine in the preparation process. The second-class solvents are highly toxic and should be restricted in use, while ethanol and ethyl acetate belong to the third-class solvents, and their use is restricted in drug GMP or other quality requirements, so it is necessary to effectively control their conte...

Claims

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Application Information

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IPC IPC(8): G01N30/88G01N30/06
Inventor 王思绪吴庆安周秋火
Owner SHANGHAI NEW HUALIAN PHARMA
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