A method for detecting solvent residues in ederaris

A detection method and solvent technology, which are used 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 repeatability. good performance, improved quality control methods

Active Publication Date: 2021-06-22
HUBEI BIO PHARMA IND TECHCAL INST +2
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  • Abstract
  • Description
  • Claims
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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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  • A method for detecting solvent residues in ederaris
  • A method for detecting solvent residues in ederaris
  • A method for detecting solvent residues in ederaris

Examples

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Embodiment Construction

[0052] 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.

[0053] 1. Instruments and reagents

[0054] Instruments: Shimadzu gas chromatography (GC2014-HS20), detector FID, Shimadzu chromatography workstation; PE gas chromatography (Clarus680-TurboMatrix 40), PE chromatography workstation.

[0055] The Adeleris used was manufactured by Hubei Institute of Biomedical Industry Technology Co., Ltd. (batch number: 151203), and the reagents used were all chromatographically pure.

[0056] Unle...

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Abstract

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. The method of the present invention comprises: 1) prepare the N,N-dimethylformamide solution of Idelaris, as need testing solution; 2) all organic solvents to be detected are mixed with N,N-dimethylformamide , as the mixed reference substance solution; 3) the need testing solution obtained in step 1) and the mixed reference substance solution obtained in step 2) are detected by gas chromatography respectively to obtain a chromatogram; 4) according to the external standard method, calculate with the peak area The content of organic solvents to be detected as described in Adelaris. The detection method of the invention can simply, quickly and accurately detect the residual amount of the organic solvent to be detected in the idelaris. Moreover, the detection method of the present invention has good applicability, durability, precision, sensitivity, accuracy, repeatability and recovery rate, and the test solution has good stability, which improves the quality control method of the 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 Patents(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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