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.
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[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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