Composition and method for detecting purity of 1-amino-2-propanol and related substances

A detection method and composition technology, applied in the field of drug detection, can solve the problems of inability to select purity, impurity content detection method report, no clear purity of 1-amino-2-propanol, etc., to achieve convenient selection and use, and calculation method Accurate and reliable results with defined purity

Active Publication Date: 2019-04-19
CHENGDU BRILLIANT PHARMA CO LTD
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  • Description
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Problems solved by technology

And the purity of 1-amino-2-propanol and which impurity therein, the content of impurity etc. do not have relevant detection method report at present
In addition, when using 1-amino-2-propanol as an important starting material of many raw materials, since there is no 1-amino-2-propanol raw material product with clear and controllable purity, it is not necessary to use it when using it. Cannot be selected according to the required purity

Method used

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  • Composition and method for detecting purity of 1-amino-2-propanol and related substances
  • Composition and method for detecting purity of 1-amino-2-propanol and related substances
  • Composition and method for detecting purity of 1-amino-2-propanol and related substances

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Embodiment Construction

[0050] The method of the present invention will be further described below through specific embodiments and experiments.

[0051] 1. Introduction

[0052] 1-Amino-2-propanol, as an important starting material of many APIs, plays an irreplaceable role in the synthesis process of APIs. In the industrial production of 1-amino-2-propanol, its isomer 2-amino-1-propanol will inevitably be introduced, because 2-amino-1-propanol and 1-amino-2- Propanol has the same reaction site and reactivity, and will be derived together with the main reaction, and its derivatives have a similar structure and polarity to the main product, and the purification process of the intermediates and finished products synthesized later has a lower clearance rate. Low, the introduction of impurity 2-amino-1-propanol will seriously affect the quality of raw materials and finished products. Therefore, in its quality control, it is necessary to detect the purity of 1-amino-2-propanol and residual 2-amino-1-pro...

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Abstract

The invention provides a method for detecting the purity of 1-amino-2-propanol and related substances. The method is used for detecting the purity of 1-amino-2-propanol and the content of an isomer (2-amino-1-propanol). The purity of 1-amino-2-propanol and the related substances are qualitatively and/or quantitatively detected through a gas chromatography method, the known impurity (2-amino-1-propanol) is calculated through a standard curve method, other unknown impurities are calculated through an area normalization method, the total impurities are equal to the sum of the content of all the known impurities and the content of all the unknown individual impurities, and the purity of 1-amino-2-propanol is calculated through the difference of 100% and the total impurity content. The purity of 1-amino-2-propanol and the isomer impurity (2-amino-1-propanol) are detected.

Description

technical field [0001] The invention belongs to the field of drug detection, in particular to a detection method for the purity of 1-amino-2-propanol and related substances. Background technique [0002] 1-Amino-2-propanol, as an important starting material of many raw materials, plays an irreplaceable role in the synthesis process, and it is inevitable to introduce Impurities, in order to ensure the purity of the synthetic drug, it is necessary to strictly control its purity and impurity content in the quality control of 1-amino-2-propanol. And the purity of 1-amino-2-propanol and which impurity therein, the content of impurity etc. do not have relevant detection method to report at present. In addition, when using 1-amino-2-propanol as an important starting material of many raw materials, since there is no 1-amino-2-propanol raw material product with clear and controllable purity, it is not necessary to use it when using it. Cannot be selected according to the required p...

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K31/133G01N30/02G01N30/06
CPCG01N30/02G01N30/06A61K31/133G01N2030/047
Inventor 吕清慧陈礼莉苏忠海
Owner CHENGDU BRILLIANT PHARMA CO LTD
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