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Detection method for residual amount of MOPS (3-(N-Morpholino)Propane-Sulfonic acid)

A detection method and residue technology, applied in the field of MOPS detection, can solve the problem of inability to detect trace MOPS residues, etc., and achieve the effects of good detection precision, detection sensitivity and high accuracy

Active Publication Date: 2016-05-04
SHANGHAI ZERUN BIOTECHNOLOGY CO LTD
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  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to provide a detection method of residual MOPS, to overcome the defect that the prior art cannot detect trace MOPS residual, can detect the residual MOPS in HPV vaccine finished product, ensure the safety of HPV vaccine finished product, have detection High precision, detection sensitivity and accuracy

Method used

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  • Detection method for residual amount of MOPS (3-(N-Morpholino)Propane-Sulfonic acid)
  • Detection method for residual amount of MOPS (3-(N-Morpholino)Propane-Sulfonic acid)
  • Detection method for residual amount of MOPS (3-(N-Morpholino)Propane-Sulfonic acid)

Examples

Experimental program
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Effect test

reference example 1

[0034] It is the standard solution of 1.0mmol / L that adopts high performance liquid chromatography detection concentration to obtain the separation spectrum of standard solution, such as figure 1 shown. Depend on figure 1 It can be seen that the MOPS characteristic peak appears at the retention time of 2.47min in the MOPS standard solution with a concentration of 1.0mmol / L.

reference example 2

[0036] Adopt high performance liquid chromatography to detect blank control (0mmol / LMOPS) and 1.0mmol / LMOPS standard solution (blank control dilution) respectively, obtain contrast collection of graphs such as figure 2 shown.

[0037] Depend on figure 2 It can be seen that the MOPS characteristic peak was not detected after the blank control sample injection, while the 1.0mmol / L MOPS standard solution (blank control dilution) could detect the obvious MOPS characteristic peak at the retention time of 2.49min.

[0038] Note: The normal retention time of MOPS detected by liquid chromatography is between 2.40±0.10min.

Embodiment 1-3

[0040] Quantitative detection of 3 parts of 1.0mmol / L MOPS standard solution, detection conditions: chromatographic column: AcclaimTrinityP1, column temperature is 30°C, 35°C, 40°C, atomization temperature is 25°C, 30°C, 35°C , mobile phase: a mixture of acetonitrile and ammonium acetate solution, the volume ratio is 1.1:1, 1.5:1, 2:1 respectively, the flow rates are: 0.4ml / min, 0.5ml / min, 0.6ml / min, sample injection The volumes are: 3μL, 5μL, 10μL. The test results are shown in Table 1.

[0041] Table 11. The detection results of 0mmol / LMOPS standard substance under different detection conditions

[0042]

[0043] As can be seen from Table 1, MOPS can be detected under the detection conditions of Examples 1-3, and the retention time is about 2.44min, and the peak areas are similar, indicating that the chromatographic conditions of Examples 1-3 can all realize the detection of trace MOPS , and the symmetry of the chromatographic peak obtained under the conditions of Examp...

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Abstract

The invention provides a detection method for a residual amount of MOPS (3-(N-Morpholino)Propane-Sulfonic acid), which is used for detecting with a high performance liquid chromatography. The MOPS is quantified by adopting a linear normalization method. The high performance liquid chromatography adopts an Acclaim Trinity P1 chromatographic column and an electric spraying detector; a mobile phase is a mixed solution of acetonitrile and an ammonium acetate solution, and the volume ratio of the acetonitrile to the ammonium acetate solution is (1:1) to (2:1); and the flow speed of the mobile phase is 0.4mL / min-0.6mL / min. The detection method for the residual amount of the MOPS, provided by the invention, can be used for detecting trace MOPS components in an HPV (Human Papillomavirus) vaccine, which cannot be detected by a chemical titration method and a C18 column liquid chromatography; and the detection method has good detection precision and high detection sensitivity and accuracy, and can be widely applied to the detection of the residual amount of the MOPS of biological products.

Description

technical field [0001] The invention belongs to the technical field of MOPS detection, in particular to a method for detecting MOPS residues. Background technique [0002] 3-(N-Morpholino)propane-sulfonic acid, English name: 3-(N-Morpholino)propane-sulfonic acid, abbreviated as MOPS, molecular formula: C 7 h 15 NO 4 S, molecular weight: 209.2633, pH range: 6.5-7.9, white crystalline powder, melting point 277-282°C, water solubility at 20°C 1000g / L, relative density 1.298g / cm 3 , whose structure is as follows: [0003] [0004] As a commonly used biological buffer solution, MOPS can be used in the production and purification of many biological products. Therefore, the residual amount of MOPS in biological products is directly related to the purity of biological products, and it is of great significance to detect the residual amount of MOPS. However, in the Chinese Pharmacopoeia, the United States Pharmacopoeia for the determination of residual solvents, and the "ICHQ3...

Claims

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Application Information

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IPC IPC(8): G01N30/60G01N30/06
CPCG01N30/06G01N30/60
Inventor 周朝明
Owner SHANGHAI ZERUN BIOTECHNOLOGY CO LTD
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