Nadiifin Sare USP BP EP 59-05-2 Methotrexate ee Daaweynta Burada
Alaabtamagac | Methotrexate |
La mid ah | (+)-Amethopterin;(+)-4-Amino-10-methylfolic acid;N-(p-(((2,4-Diamino-6-pteridinyl)methyl)methylamino)benzoyl)-L-glutamic acid |
CAS Maya. | 59-05-2 |
Muuqashada | Budada crystalline jaalaha ah |
Qaanuunka molecular | C20H22N8O5 |
Miisaanka Molecular | 454.44 |
Codsiga | Darajada daawada ama ujeedada cilmi baarista |
Baakad | Sida ku cad codsigaaga |
Kaydinta | Ku kaydi weel cidhiidhi ah oo iftiin u adkaysta meel qabow |
Shahaadada Imtixaanka Falanqaynta sida ku cad: EP9.0 MethotrexateLambarka CAS:59-05-2 | ||
WAXYAABAHA | HEERARKA | NATIIJADA |
Muuqashada | Jaalle ama oranji, crystalline, budada hygroscopic | U hogaansama |
Aqoonsiga | IR; UV | U hogaansama |
Solubility | Dhab ahaantii aan biyo ku milmin, ethanol (96%) iyo methylene chloride.Waxay ku milantaa asiidhyada macdanta ah iyo xalalka millatariga ee alkali hydroxides iyo carbonates. | U hogaansama |
Biyo | ≤13% | 11.8% |
la xidhiidhaWalxo | Xumaan B≤0.3%Xumaanta C≤0.5%Xumaanta E≤0.3%wasakhda H≤0.2%Nijaasnimo I≤0.2%Nijaasaha Aan La cayimin≤0.05% Wadarta wasakhda aan ahayn B,C&E≤0.5% | 0.04%0.45%0.03%NDND0.02% 0.04% |
Nadiifinta Enantiomeric | ≤3.0% | 1.6% |
Biraha culus | ≤20pm | U hogaansama |
Sulfated Ash | ≤0.1% | 0.07% |
Xalalka Haraaga ah | Ethyl ether≤500ppmAcetone ≤1000ppmEthanol≤ 2000ppm | 20ppm63ppm48ppm |
Qiimayn | 97.0 ~ 102.0% | 99.49% |
Shahaadada Imtixaanka Falanqaynta sida ku cad: USP32 Methotrexate CAS No.: 59-05-2 | ||
WAXYAABAHA | HEERARKA | NATIIJADA |
SIFOOYINKA | Budada crystalline jaalaha ah | U hogaansama |
AQOONSIGA | IR.UV Conform | U hogaansama |
BIYAHA | ≤12% | 10.8% |
HARGEYSA GUDDINTA | ≤0.1% | 0.07% |
Daahirnimada Chromatographic | Nijaasta keliya: ≤0.5% | 0.27% |
Wadarta wasakhda:≤2.0 % | 0.73% | |
REER GAAR AH | Inta u dhaxaysa +19 ° ilaa +24 ° | +21.25° |
ASSAY | 98.0 ~ 102.0% | 99.27% |
Macluumaadka Shirkadda
√ Waayo-aragnimada buuxda ee lakabka maamulka ee warshadda iyo farsamayaqaannada raacsan; √ Tayada had iyo jeer waa tixgelinteena ugu sareysa, nidaamka QC adag; √ 11 sano oo khibrad u leh kooxda iibka dhoofinta; √ shaybaadhka R&D ee madaxa banaan; √ Laba aqoon-is-weydaarsiyo GMP-dheer oo saxeexan; √ Khayraadka hodanka ah ee warshado badan oo shaqo la'aan ah oo loogu talagalay mashruuc la habeeyey; √ Kooxda shaqada oo hufnaan sare leh oo leh waddo joogto ah.Halkan ku qor fariintaada oo noo soo dir