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Method for detecting residual of solvents in idelalisib

A detection method and solvent technology, which are applied in the detection of solvent residues in Adalaris, and the detection of various organic solvent residues in Adalaris by gas chromatography, can solve problems such as incomplete removal, and achieve good recovery and improvement. Quality control method, reproducible results

Active Publication Date: 2018-04-27
HUBEI BIO PHARMA IND TECHCAL INST +2
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  • Abstract
  • Description
  • Claims
  • Application Information

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Problems solved by technology

[0002] Residual solvents in pharmaceuticals refer to organic volatile compounds that are used in the production of raw materials, excipients, and preparations but cannot be completely removed during the process

Method used

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  • Method for detecting residual of solvents in idelalisib
  • Method for detecting residual of solvents in idelalisib
  • Method for detecting residual of solvents in idelalisib

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Embodiment Construction

[0053] Below in conjunction with specific embodiment, further illustrate the present invention. It should be understood that these embodiments are only used to illustrate the technical solution of the present invention, and are not intended to limit the protection scope of the present application. Moreover, after reading the content recorded in the present invention, those skilled in the art can make various changes or modifications to the present invention, and these equivalent forms also belong to the protection scope of the present application.

[0054] 1. Instruments and reagents

[0055] Instruments: Shimadzu gas chromatography (GC2014-HS20), detector FID, Shimadzu chromatography workstation; PE gas chromatography (Clarus680-TurboMatrix 40), PE chromatography workstation.

[0056] The Adelalis used was manufactured by Hubei Institute of Biomedical Industry Technology Co., Ltd. (batch number: 151203), and the reagents used were all chromatographically pure.

[0057] Unle...

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Abstract

The invention relates to a method for detecting the residual of solvent in idelalisib, and concretely relates to a method for detecting the residual of various organic solvents in idelalisib by gas chromatography. The method comprises the following steps: 1) preparing an N,N-dimethylformamide solution of idelalisib, used as a test solution; 2) mixing all organic solvents to be detected with the N,N-dimethylformamide to form a mixed reference substance solution; 3) respectively carrying out gas chromatography detection on the test solution obtained in step 1) and the mixed reference substance solution obtained in step 2) to obtain chromatograms; and 4) calculating the content of every organic solvent to be detected in idelalisib according to peak areas through an external standard technology. The detection method can achieve easy, fast and accurate detection of the residual amounts of the organic solvents to be detected in the idelalisib. The detection method also has the advantages ofgood applicability, good durability, good precision, good sensitivity, good accuracy, good repeatability, good recovery rate, good stability of the test solution and improvement of the quality controlmethod of the above medicine.

Description

technical field [0001] The invention relates to a method for detecting residual solvents in idellaris, in particular to a method for detecting residues of various organic solvents in idellaris by gas chromatography, and belongs to the field of drug analysis. Background technique [0002] Residual solvents in pharmaceuticals refer to organic volatile compounds that are used in the production of raw materials, excipients, and preparations but cannot be completely removed during the process. In the synthesis process of raw materials, choosing an appropriate solvent can increase the yield or determine the properties of the drug, such as crystal form, purity, dissolution rate, etc. Therefore, organic solvents are essential and very critical substances in drug synthesis reactions. When the level of residual solvent contained in medicine is higher than the safe value, it will cause harm to the human body or the environment, so the control of residual solvent has attracted more and...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02
CPCG01N30/02
Inventor 徐泽彬胡慧任冰李浩远黄璐
Owner HUBEI BIO PHARMA IND TECHCAL INST
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