Impurities of baricitinib and preparation and detection methods thereof

A baricitinib and impurity technology, which is applied to medical preparations containing active ingredients, measuring devices, and pharmaceutical formulas, can solve problems such as optimization and selection, and achieve the effects of ensuring safety and reliability, simple operation, and high yield
CN108976233APending Publication Date: 2018-12-11NANJING YOUKE BIOLOGICAL MEDICAL RES +3
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Patent Information

Authority / Receiving Office
CN · China
Current Assignee / Owner
NANJING YOUKE BIOLOGICAL MEDICAL RES
Publication Date
2018-12-11

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Abstract

The invention belongs to the field of drug synthesis, and in particular relates to three impurities of baricitinib: impurities A, B and C, a preparation method, structural characterization and a detection method of the three impurities and an application of controlling purity of a baricitinib raw material or a preparation as an impurity reference substance as well. The invention can provide a standard reference substance for quality control and clinical medication safety detection of baricitinib, so that the clinical medication safety and reliability can be guaranteed.
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Description

technical field

[0001] The present invention relates to the field of medicine and chemical industry, in particular to the impurity of baricitinib, its preparation method, detection method and composition containing the impurity. Background technique

[0002] Baricitinib (Olumiant, I) is a selective JAK1 and JAK2 inhibitor jointly developed by Eli Lilly and its partner Incyte, which can inhibit IL-6 and IL-23 and other inflammatory cytokines Intracellular signaling of the chemical name 1-(ethylsulfonyl)-3-[4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl ]-3-azetidine acetonitrile, its structural formula is as shown in formula (I). This product has been approved by the European Union in 2017 for the treatment of adults with moderate to severe rheumatoid arthritis who do not respond or are intolerant to current rheumatoid arthritis drugs. It can be used as a single drug or combined with a wide range of drugs Used in conjunction with methotrexate.

[0003]

[0004] Exi...

Claims

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