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A quick and easy method for the detection of peptide residues

A detection method and a simple technology, applied in the field of chemical analysis, can solve the problems of cumbersome operation, inability to monitor in real time, and high operating costs

Active Publication Date: 2016-01-13
SHANGHAI SOHO YIMING PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0006] The purpose of the present invention is to provide a simple, fast and reliable detection method for residues of all polypeptide substances, to overcome the shortcomings of previous detection operations such as cumbersome operation, high operating costs, and inability to monitor in real time, and can detect 10ppm of polypeptide residues

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0040] The method for the present invention to detect the residual amount of polypeptide substance is as follows:

[0041] The preparation of biuret reagent: take an appropriate amount of sodium hydroxide, add purified water to dissolve and dilute to a solution with a concentration of 0.1g / ml, as reagent A; weigh copper sulfate (CuSO 4 ·5H 2 O) appropriate amount, add purified water to dissolve and dilute to the solution that concentration is 0.01g / ml, as reagent B.

[0042] Determination method: Take 100ml~500ml of rinse water for cleaning containers and equipment, heat and concentrate in a beaker until the volume is less than 10ml, transfer the residual liquid to a 10ml volumetric flask, rinse the beaker with purified water, and transfer the rinse solution to In the volumetric flask, add water to 10ml as the test solution; take an appropriate amount of bivalirudin, add purified water to dissolve and dilute to a solution with a concentration of 0.1~0.5mg / ml, and use it as a ...

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PUM

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Abstract

The invention relates to a fast and simple colorimetric detection method for polypeptide residues. The biuret colorimetric reaction is used for the detection of polypeptide residues, and compared with the positive control solution, it can clean the instruments and containers used in the production process of synthetic polypeptides. The residual amount of the polypeptide is subjected to limit detection, which is used for the monitoring of cleaning effect of instruments and containers in the daily production of polypeptide substances and the detection of cleaning verification. The biuret reagent is composed of reagent A and reagent B. Reagent A is 0.1g / ml sodium hydroxide solution, and reagent B is 0.01g / ml copper sulfate solution. When using it, add 2ml of reagent A first, oscillate and shake well to form Alkaline reaction environment, and then add 4 drops of reagent B. Biuret reagent is generally used for the determination of protein content. The present invention utilizes its exclusive low characteristic and uses it for the detection of all polypeptide residues. At the same time, it solves the disadvantage of its poor sensitivity and makes it suitable for 10ppm polypeptide residues. detection.

Description

technical field [0001] The invention relates to a fast and simple colorimetric detection method for polypeptide residues, which can detect the polypeptide residues in containers used in the polypeptide synthesis and production process after cleaning, and belongs to the field of chemical analysis. Background technique Background technique [0002] Polypeptides are compounds formed by the condensation of amino acids. Different polypeptides are composed of different numbers of amino acids and contain different numbers of peptide bonds in their structures. uret reaction. Therefore, biuret reagent can be used for the detection of protein or polypeptide, and its color depth is proportional to the concentration of protein or polypeptide, and can be determined by colorimetry. [0003] In the production process of peptides, there are processes of synthesis, purification, and freeze-drying. The containers used include synthesis tanks, turnover bottles, freeze-drying trays, etc. Sin...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N21/78
Inventor 曹建红朱亮孟晶
Owner SHANGHAI SOHO YIMING PHARMA