Ukuhlanzeka okuphezulu kwe-USP BP EP 59-05-2 Methotrexate yokwelashwa kwe-Tumor
Umkhiqizoigama | I-Methotrexate |
Omqondofana | (+)-I-Amethopterin;(+)-4-Amino-10-methylfolic acid;N-(p-(((2,4-Diamino-6-pteridinyl)methyl)methylamino)benzoyl)-L-glutamic acid |
Inombolo ye-CAS. | 59-05-2 |
Ukubukeka | I-crystalline powder ephuzi |
I-Molecular Formula | C20H22N8O5 |
Isisindo samangqamuzana | 454.44 |
Isicelo | Ibanga lemithi noma inhloso yocwaningo |
Ukupakisha | Njengesicelo sakho |
Isitoreji | Londoloza ezitsheni eziqinile, ezimelana nokukhanya endaweni epholile |
Isitifiketi Sokuhlaziya Ukuhlolwa ngokuya nge-: EP9.0 I-MethotrexateInombolo ye-CAS:59-05-2 | ||
IZINTO | AMAZINGA | IMIPHUMELA |
Ukubukeka | Ophuzi noma osawolintshi, i-crystalline, i-hygroscopic powder | Iyahambisana |
Ukuhlonza | IR; UV | Iyahambisana |
Ukuncibilika | Ayincibiliki emanzini, ku-ethanol (96%) naku-methylene chloride.Incibilika ku-dilute mineral acids nasezixazululweni ze-alkali hydroxides nama-carbonates. | Iyahambisana |
Amanzi | ≤13% | 11.8% |
OkuhlobeneIzinto | Ukungcola B≤0.3%Ukungcola C≤0.5%Ukungcola E≤0.3%Ukungcola H≤0.2%Ukungcola I≤0.2%Ukungcola Okungashiwongo≤0.05% Isamba sokungcola ngaphandle kwe-B,C&E≤0.5% | 0.04%0.45%0.03%NDND0.02% 0.04% |
I-Enantiomeric Purity | ≤3.0% | 1.6% |
Izinsimbi Ezisindayo | ≤20ppm | Iyahambisana |
Umlotha one-sulphate | ≤0.1% | 0.07% |
Izincibilikisi Ezisele | I-Ethyl ether≤500ppmI-acetone≤1000ppmI-Ethanol≤ 2000ppm | 20ppm63ppm48ppm |
Isivivinyo | 97.0-102.0% | 99.49% |
Isitifiketi Sokuhlaziya Ukuhlolwa ngokuya nge-: USP32 I-Methotrexate CAS No.: 59-05-2 | ||
IZINTO | AMAZINGA | IMIPHUMELA |
IZIPHUMA | I-crystalline powder ephuzi | Iyahambisana |
UKUKHOMBA | I-IR.I-UV Conform | Iyahambisana |
AMANZI | ≤12% | 10.8% |
INSALELA EKUSHISENI | ≤0.1% | 0.07% |
Ubumsulwa beChromatographic | Ukungcola okukodwa:≤0.5% | 0.27% |
Ukungcola Okuphelele:≤2.0 % | 0.73% | |
UKUZUNGUZA OKUTHILE | Phakathi kuka +19° kuya +24° | +21.25° |
I-ASSAY | 98.0-102.0% | 99.27% |
Ulwazi Lwenkampani
√ Isipiliyoni esigcwele se-Management layer kubalandeli befektri nabanekhono; √ Ikhwalithi ihlale iwukucatshangelwa kwethu okuphezulu, uhlelo oluqinile lwe-QC; √ Ithimba leminyaka engu-11 elinesipiliyoni sokuthumela ngaphandle; √ Ilebhu ye-R&D ezimele; √ Izinkundla zokucobelelana ngolwazi ezimbili ze-GMP zesikhathi eside ezisayiniwe; √ Izinsiza ezicebile zamafekthri amaningi angasebenzi wephrojekthi eyenziwe ngokwezifiso; √ Ithimba elisebenzayo elisebenza kahle elinendlela engaguquki.Bhala umyalezo wakho lapha futhi usithumelele wona