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Method for analyzing imidazole residues in recombinant human parathyroid hormone for injection

An analytical method and technology of teriparatide, applied in the field of residue analysis, can solve problems such as imidazole-free residue analysis, and achieve the effects of good verification results, good separation, and control of product quality and safety.

Active Publication Date: 2020-04-10
BEIJING GENETECH PHARML
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Problems solved by technology

[0005] The main purpose of the present invention is to provide an analysis method for imidazole residues in recombinant human teriparatide for injection, to solve the problem of imidazole residues in biological preparation products such as recombinant human teriparatide for injection in the prior art. questions for analysis

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  • Method for analyzing imidazole residues in recombinant human parathyroid hormone for injection
  • Method for analyzing imidazole residues in recombinant human parathyroid hormone for injection
  • Method for analyzing imidazole residues in recombinant human parathyroid hormone for injection

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Embodiment Construction

[0033] It should be noted that, in the case of no conflict, the embodiments in the present application and the features in the embodiments can be combined with each other. The present invention will be described in detail below in conjunction with examples.

[0034] As mentioned in the background technology, there is no report on the analysis of imidazole residues in biological products such as recombinant human teriparatide for injection in the prior art. In order to make up for this gap, the inventors of the present application used Recombinant human teriparatide for injection was used as the research object, and a detection method for imidazole residues in such biological products was thoroughly studied and developed. details as follows:

[0035] The content of imidazole in the product is low, and imidazole is easily soluble in water, and has a large absorption at the ultraviolet wavelength of about 210nm. The main component of the product (PTH) is a small molecular protei...

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Abstract

The invention provides a method for analyzing imidazole residues in recombinant human parathyroid hormone for injection. The analysis method comprises the following step: carrying out high performanceliquid chromatography analysis on imidazole residues in recombinant human parathyroid hormone for injection by adopting a C18 chromatographic column and taking a mixed solution of a solution a and asolution b as a mobile phase. The solution a is a 0.4-0.6 mg / ml of 1-octanesulfonic acid aqueous solution, the solution b is an acetonitrile-methanol solution, and the volume ratio of acetonitrile tomethanol in the acetonitrile-methanol solution is 20: 80-60: 40. According to the analysis method, the appearance time, the peak pattern and the separation degree of imidazole residues are all good; the specificity, the detection limit, the quantification limit, the linearity, the repeatability, the accuracy and the durability of the analysis method are verified through an imidazole limit detection method, and control over the PTH production technological process and the product quality safety is facilitated when the analysis method is applied to analysis of imidazole residues in PTH.

Description

technical field [0001] The invention relates to the field of residue analysis, in particular to an analysis method for imidazole residues in recombinant human teriparatide for injection. Background technique [0002] For the detection of imidazole residues, there are reports in the prior art on the detection of nitroimidazole residues in animal source foods (such as pork, pig liver, etc.). The detection principle is to extract the animal tissue samples through ethyl acetate vibration extraction, liquid-liquid distribution and solid phase extraction purification, then use liquid chromatography-tandem mass spectrometry for detection, and external standard method for quantification. There are also reports on the detection of levamisole in aquatic products by liquid chromatography-tandem mass spectrometry. The detection principle is: directly extract the levamisole in the sample with ethyl acetate under alkaline conditions, extract it with acidic aqueous solution, and use it und...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74
CPCG01N30/02G01N30/06G01N30/30G01N30/32G01N30/34G01N30/74
Inventor 翟盼陶芳郭玉芬闻亚磊刘娜
Owner BEIJING GENETECH PHARML
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