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GC detection method of triethylamine residue in abenaptide precursor

A detection method and technology of triethylamine, applied in measuring devices, instruments, scientific instruments, etc., can solve the problem of inability to accurately detect triethylamine, and achieve the effects of short sample detection time, sensitive detection and strong specificity

Inactive Publication Date: 2019-07-09
HEBEI CHANGSHAN BIOCHEM PHARMA +1
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Salt formation of triethylamine and trifluoroacetic acid, resulting in inaccurate detection of triethylamine

Method used

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  • GC detection method of triethylamine residue in abenaptide precursor
  • GC detection method of triethylamine residue in abenaptide precursor
  • GC detection method of triethylamine residue in abenaptide precursor

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0068] The determination of triethylamine content in the ibenatide precursor comprises the following steps:

[0069] a. Solution preparation

[0070] ①Stock solution of reference substance: take about 1g of triethylamine to a 100ml volumetric flask and add 0.08M aqueous sodium hydroxide solution to prepare a stock solution of triethylamine reference substance with a concentration of 9-11mg / ml for future use;

[0071] ②Reference substance solution: Take 10ml of the above-mentioned triethylamine reference substance stock solution and add 0.08M sodium hydroxide aqueous solution to a 100ml volumetric flask, dilute to volume, shake well, and prepare a triethylamine reference substance with a concentration of 0.9-1.1mg / ml Product solution, spare;

[0072] ③ System suitability solution: take 0.1g of the precursor of ibenatide and add 5ml of triethylamine reference substance solution to dissolve, shake well, and set aside;

[0073] ④Test solution: take 0.1g of the test substance of ...

Embodiment 2

[0112] a. Solution preparation

[0113] ①Stock solution of reference substance: take about 1g of triethylamine to a 100ml volumetric flask and add 0.1M aqueous sodium hydroxide solution to prepare a stock solution of triethylamine reference substance with a concentration of 9-11mg / ml for future use;

[0114] ②Reference substance solution: Take 10ml of the above-mentioned triethylamine reference substance stock solution and add 0.1M sodium hydroxide aqueous solution to a 100ml volumetric flask, dilute to volume, shake well, and prepare a triethylamine reference substance with a concentration of 0.9-1.1mg / ml Product solution, spare;

[0115] ③ System suitability solution: take 0.1g of the precursor of ibenatide and add 5ml of triethylamine reference substance solution to dissolve, shake well, and set aside;

[0116] ④ Test solution: take 0.1 g of the test product of the precursor of ibenatide, accurately add 5 ml of 0.1 M sodium hydroxide aqueous solution to dissolve, shake wel...

Embodiment 3

[0138] a. Solution preparation

[0139] ①Stock solution of reference substance: take about 1g of triethylamine to a 100ml volumetric flask and add 0.08M aqueous sodium hydroxide solution to prepare a stock solution of triethylamine reference substance with a concentration of 9-11mg / ml for future use;

[0140] ②Reference substance solution: Take 10ml of the above-mentioned triethylamine reference substance stock solution and add 0.08M sodium hydroxide aqueous solution to a 100ml volumetric flask, dilute to volume, shake well, and prepare a triethylamine reference substance with a concentration of 0.9-1.1mg / ml Product solution, spare;

[0141] ③ System suitability solution: take 0.1g of the precursor of ibenatide and add 5ml of triethylamine reference substance solution to dissolve, shake well, and set aside;

[0142]④Test solution: take 0.1g of the test substance of the precursor of ibenatide, add 5ml of 0.08M sodium hydroxide aqueous solution to dissolve it, shake well, and s...

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Abstract

The invention discloses a GC detection method of triethylamine residue in an abenaptide precursor. The detection method comprises preparing a solvent, preparing a sample and respectively performing GCdetection on a trimethylamine reference solution, a system applicability solution and a test solution, wherein the detection condition is a chromatographic column filled with 6% of cyanopropyl-phenyl-methylpolysilicone, the column temperature is 35-45 DEG C, the carrier gas is nitrogen, the flow velocity is 2.5-3.5ml / min, and a detector is FID. Through the detection method disclosed by the invention, the quantification can be performed on the trimethylamine residue in the abenaptide precursor. The detection method is simple in operation, low in detection cost, high in sensitivity, high in accuracy, and accurate and reliable; the trimethylamine quantification is limited at 2ppm, and far less than the trimethylamine limit of 1000ppm; a detection result can satisfy a detection mass result judgment, suitable for laboratory detection and enterprise product quality control, and can be used for detecting the trimethylamine residue in the abenaptide precursor.

Description

technical field [0001] The invention relates to a detection method for triethylamine residues in ibenatide precursors. Background technique [0002] GLP-1 is a peptide hormone that exists in the human body and acts synergistically with other regulatory systems through cyclic adenosine monophosphate or other intracellular signaling mechanisms to induce insulin secretion, stimulate insulin biosynthesis, inhibit glucagon secretion, delay Stomach emptying and food intake reduced while nourishing the pancreas. [0003] As a GLP-1 analogue, Exendin-4 can induce physiological effects similar to GLP-1 through the GLP-1 receptor, but it is more potent and lasts longer than GLP-1. [0004] Ibenatide precursor is a synthetically modified Exendin-4, which avoids rapid degradation and rapid renal clearance by binding to recombinant human serum albumin, thus prolonging the duration of action and having similar properties to Exendin-4 physiological function and mechanism of action. [0...

Claims

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Application Information

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IPC IPC(8): G01N30/88
CPCG01N30/88G01N2030/8813
Inventor 李云峰郭静刘岩涛曹学婷白茜茜刘晓霞刘云仙胡丽英
Owner HEBEI CHANGSHAN BIOCHEM PHARMA
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