Method for controlling impurities in pipericide

A technology of piperbocilide and a control method, which is applied in the field of impurity control in breast cancer drug piperbacillide, can solve problems such as poor impurities and low product purity, and achieve the effects of excellent quality, high purity and simple control method.

Inactive Publication Date: 2021-07-13
JIANGXI GUOYAO PHARMA LLC +1
3 Cites 0 Cited by

AI-Extracted Technical Summary

Problems solved by technology

[0007] In the prior art, there are many synthetic methods for palbociclib, but the contr...
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Method used

As can be seen from Table 1, the palbociclib content generated in embodiment 1-3 is 99.23%, 99.19%, 99.27%, and the total impurity content is 0.77%, 0.81%, 0.73%, comparative example 1-3 The content of palbociclib generated in the method is 96.71%, 95.38%, 95.30%, and the total impurity content is 3.29%, 4.62%, 4.70%, as can be seen by comparing examples 1-3 with comparative examples 1-3, the examples The purity of the palbociclib generated in 1-3 is obviously higher than that of Comparative Example 1-3, thus illustrating that the present invention can effectively control the main organic impurities by controlling the purity of the intermediates, and its ...
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Abstract

The invention discloses a method for controlling impurities in pipericide, and relates to the technical field of pharmaceutical chemical. The content of the impurities in the pipericide is reduced by controlling the purity of an obtained intermediate I. The content of a compound I in the intermediate I does not exceed 1.0%, the content of a compound II in the intermediate I does not exceed 5.0%, the content of a compound III in the intermediate I does not exceed 5.0%, the maximum single unknown impurity content does not exceed 2.0%, and the total impurity content does not exceed 9.0%. The method has the beneficial effect that main organic impurities can be effectively controlled by controlling the purity of the intermediate. The control method disclosed by the invention is simple and easy to realize, the product with higher purity and better quality is obtained, and the method is suitable for being applied to industrial production.

Application Domain

Organic chemistry

Technology Topic

Chemical compoundAnalytical chemistry +2

Image

  • Method for controlling impurities in pipericide
  • Method for controlling impurities in pipericide
  • Method for controlling impurities in pipericide

Examples

  • Experimental program(3)
  • Comparison scheme(3)

Example Embodiment

[0072] Example 1
[0073] In this embodiment, the purity of each intermediate body is controlled is as follows:
[0074] The purity of intermediate I is as follows: The compound I contains 0.4%, the compound II content is 1.5%, and the maximum single unknown impurity content is 1.2%, and the total impurity content is 3.4%.
[0075] The purity of the intermediate II is as follows: The intermediate I content contains 0.1%, the maximum single unknown impurity content is 1.0%, and the total impurity content is 2.3%.
[0076] The purity of the piperboxate is as follows: The impurity L content contains 0.1%, the impurity K content must not exceed 0.1%, the impurity M content is 0.2%, the impurity N content is 0.2%, the maximum single unknown impurity content is 0.1%, the total impurity content is 0.8% .
[0077] The content of the resulting final product pipercycy and its impurity content is detected, and the results are shown in Table 1.

Example Embodiment

[0078] Example 2
[0079] In this embodiment, the purity of each intermediate body is controlled is as follows:
[0080] The purity of intermediate I is as follows: The compound I contains 0.3%, the compound II content is 1.1%, and the maximum single unknown impurity content is 0.9%, and the total impurity content is 2.7%.
[0081] The purity of intermediate II is as follows: The intermediate I content contains 0.1%, and the maximum single unknown impurity content is 0.9%, and the total impurity content is 1.8%.
[0082] The purity of pipercy-Sepillating has a purity of the impurity L content of 0.1%, an impurity K content of 0.1%, an impurity M content of 0.1%, an impurity N content of 0.2%, a maximum single unknown impurity content of 0.1%, and the total impurity content of 0.7%.
[0083] The content of the resulting final product pipercycy and its impurity content is detected, and the results are shown in Table 1.

Example Embodiment

[0084] Example 3
[0085] In this embodiment, the purity of each intermediate body is controlled is as follows:
[0086] The purity of the intermediate I is as follows: The compound I contains 0.3%, the compound II content is 1.4%, and the maximum single unknown impurity content is 1.1%, and the total impurity content is 3.5%.
[0087] The purity of the intermediate II is as follows: The intermediate I content contains 0.2%, the maximum single unknown impurity content is 0.9%, and the total impurity content is 3.0%.
[0088] The purity of pipercysoate is as follows: The impurity L content contains 0.1%, and the impurity K content is 0.1%. The impurity M content is 0.1%, the impurity N content is 0.2%, and the maximum single unknown impurity content is 0.2%, and the total impurity content is 0.9%.
[0089] The content of the resulting final product pipercycy and its impurity content is detected, and the results are shown in Table 1.
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Description & Claims & Application Information

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