Pralatrexate degraded impurities and preparation method thereof

A technology of pralatrexate and impurities, which is applied in the field of pralatrexate to degrade impurities, which can solve the problems of limited reaction degree, structural stability, difficult degradation, separation, and no compound synthesis reports.
CN103588775BActive Publication Date: 2016-08-17连云港恒运药业有限公司
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Patents(China)
Current Assignee / Owner
连云港恒运药业有限公司
Publication Date
2016-08-17

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Abstract

The invention relates to a pralatrexate degradation impurity and a preparation method thereof. Specifically, the formula (I) of the pralatrexate degradation impurity is N-[4-1- [(2-amino-4-hydrox-6-pteridine) methyl]-3-butine-1-group] benzoyl]-L-glutamate. An N-[4-1- [(2-amino-4-diamido-6-pteridine) methyl]-3-butine-1-group] benzoic acid compound is subjected to substitution, condensation and hydrolysis, and a target compound is obtained, so that the pralatrexate degradation impurity is synthesized. According to the method, the compound of the formula (I) is chemically synthesized for the first time, and the obtained target compound can be separated efficiently and rapidly.
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Description

technical field

[0001] The present invention relates to a kind of N-[4-[1-[(2-amino-4-hydroxyl-6-pteridyl)methyl]-3-butyn-1-yl]benzoyl]-L-glucose Amino acid and its preparation method, the compound is the degradation impurity of pralatrexate. Background technique

[0002] Pralatrexate (Pralatrexate, the structure shown below) was first synthesized by SRI, and its preclinical and clinical research was carried out in cooperation with Memorial Sloan-Kettering (MSKCC). In 2003, Allos Therapeutics Inc. acquired its global development rights from SRI and MSKCC. In September 2009, the FDA approved the new drug application for pralatrexate as an orphan drug for peripheral T-cell lymphoma, and it was launched in the United States in October 2009.

[0003]

[0004] Pralatrexate is the first drug approved by the FDA for the treatment of peripheral T-cell lymphoma. Clinical studies have found that it can reduce tumor volume and prolong the survival of cancer patients.

[0005] In...

Claims

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