Khoom Description
Crizotinib yog hmoov dawb mus rau daj ntseg daj. Nws yog qhov ncauj me me molecule tyrosine kinase inhibitor feem ntau siv los kho cov neeg mob uas muaj mob hauv zos lossis metastatic uas tsis yog-mob ntsws cancer (NSCLC) uas zoo rau anaplastic lymphoma kinase (ALK) raws li kev txiav txim los ntawm SFDA- pom zoo kuaj.
Daim ntawv thov
Crizotinib capsules yog qhia rau kev kho mob ntawm cov neeg mob uas muaj mob loj heev hauv zos lossis metastatic tsis yog -mob ntsws cancer (NSCLC) uas zoo rau anaplastic lymphoma kinase (ALK) raws li SFDA- pom zoo kuaj. Kev pom zoo rau qhov kev qhia no feem ntau yog ua raws li cov pov thawj ntawm lub hom phiaj teb tus nqi (ORR) thiab kev nce qib-kev muaj sia nyob dawb (PFS); tam sim no, tsis muaj pov thawj ntawm tag nrho cov ciaj sia taus (OS) tau txais txiaj ntsig los ntawm cov khoom no.
Txuj kev zoo
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Cov khoom |
Txuj |
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Qhov tshwm sim |
Dawb rau lub teeb daj hmoov
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Kev txheeb xyuas |
Los ntawm HPLC. Lub sijhawm khaws cia ntawm lub ncov loj ntawm Sample tov sib haum mus rau qhov kev daws teeb meem, raws li tau txais hauv Assay. |
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Yam khoom |
Ib leeg siab tshaj impurity NMT 0.2% |
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Yam khoom |
Tag nrho impurities NMT 1.0% |
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Cov ntsiab lus dej |
Tsawg dua los yog sib npaug1.0% 1.0% NMT |
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Residual Solvents |
Acetonitrile NMT 0.041% |
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Residual Solvents |
Dichloromethane NMT 0.06% |
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Residual Solvents |
Toluene NMT 0.089% |
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Residue ntawm Ignation |
0.1% NMT |
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Assay |
98.0%-102.0% |
Kev khaws cia thiab kev thauj mus los
Crizotinib yuav tsum khaws cia ntawm ** tsis siab tshaj 30℃**. Qee qhov chaw qhia tias qhov ntsuas kub zoo ntawm 2℃thiab 8℃(piv txwv li, lub tub yees txias), tab sis yuav tsum tau saib xyuas kom tsis txhob muaj cov tshuaj khov. Xyuas kom cov tshuaj khaws cia rau hauv qhov chaw qhuav, tsaus, thiab qhov kub thiab txias - ib puag ncig ruaj khov, nyob deb ntawm qhov chaw sov thiab tshav ntuj ncaj qha. Lub teeb tuaj yeem cuam tshuam rau kev ruaj ntseg ntawm cov tshuaj, yog li nws yuav tsum tau muab cia rau hauv qhov chaw tsaus, xws li siv lub thawv opaque lossis muab tso rau hauv lub txee. Khaws lub ntim thawj ntawm cov tshuaj kom zoo; cov tshuaj no feem ntau yog muab rau hauv lub raj mis kaw los yog cov pob hlwv.
Kev lag luam
Peb cov khoom raug muag zoo nyob rau hauv ntau tshaj 60 lub teb chaws thiab cheeb tsam xws li North America, Western Europe, Southeast Asia, Central thiab South America, thiab lwm yam. Peb tau tsim ntev -lub sij hawm thiab ruaj khov kev sib raug zoo nrog cov tuam txhab tshuaj nyob rau hauv Teb chaws Europe, lub tebchaws United States, tim Nkij teb chaws, lub teb chaws Yelemees, Iran, Russia, South Kauslim, Is Nrias teb thiab lwm lub teb chaws.
Cim npe nrov: Crizotinib CAS 877399-52-5, Tuam Tshoj crizotinib cas 877399-52-5 manufacturers, lwm tus neeg
