Itraconazole CAS 84625-61-6 Assay 98.5~101.5%

Itraconazole ine kwete pasi pe98.5 muzana uye kwete kupfuura 101.5 muzana yeC35H38Cl2N8O4, yakaverengwa pane yakaomeswa.
Packaging uye kuchengetedza-Chengetedza mumidziyo yakasimba, isingagadzike chiedza, uye chengetedza pane tembiricha.
USP Reference mwero <11>-
USP Itraconazole RS
USP Miconazole RS
Identification-
A: Infrared Absorption <197K>.
Angular kutenderera <781A>: pakati -0.10 ° uye +0.10 °, kuyerwa pa20 °
Test solution: 100 mg per mL, mu methylene chloride
Melting range <741>: pakati pe166° ne170°
Kurasikirwa pakuoma <731> -Dry nezve 1 g pa 105 ° kwemaawa mana: inorasikirwa kwete kupfuura 0.5% yehuremu hwayo.
Zvisaririra pakubatidza <281>: kwete kupfuura 0.1%, yakatarwa pa 1.0 g.
Related compounds-
Solution A: 0.08 M tetrabutylammonium hydrogen sulfate.
Mhinduro B: acetonitrile
Diluent-Gadzirira musanganiswa we methanol uye tetrahydrofuran (1: 1).
Mushonga wakajairwa-Dingura huremu hwakayerwa nemazvo hweUSP Itraconazole RS muDiluent, nhanho kana zvichidikanwa y, kuwana mhinduro ine huwandu hunozivikanwa hunosvika 0.05 mg per mL.
Resolution solution-Dissolve akakodzera uwandu hweUSP Itraconazole RS uye USP Miconazole muRS muDiluent kuti uwane mhinduro ine zvinozivikanwa zvekudzika kweinenge 0.05 mg imwe neimwe pa mL.
Muedzo wemhinduro-Dyisa huwandu hwakayerwa nemazvo hweItraconazole muDiluent kuti uwane mhinduro ine huwandu hunozivikanwa hunosvika 10 mg pamL.
Chromatographic system (ona Chromatography <621>) -Iyo chromatograph yemvura inogadzirwa ne 225-nm detector uye 4.6-mm × 10-cm column ine 3- μm packing L1.Chiyero chekuyerera chinenge 1.5 mL paminiti.Iyo tembiricha yembiru inochengetwa pa30 °.Iyo chromatograph yakarongedzwa sezvinotevera
Time Solution A Solution B
(maminitsi) (%) (%) Elution
0–20 80→50 20→50 mutsetse wemutsetse
20–25 50 50 isocratic
25–30 80 20 kuenzana
[Cherechedza-Enzanisa koramu kweinenge maminetsi makumi matatu neacetonitrile pachiyero chekuyerera che1.5 mL paminiti uye wozoenzana pane yekutanga kuumbwa kweanokwana maminetsi mashanu.]
Chromatograph the Resolution solution, uye rekodha mhinduro dzepamusoro sekutaurirwa kweMaitiro: sarudzo, R, pakati pemiconazole uye itraconazole haisi pasi pe2.0.
Maitiro-Baya jekiseni mavhoriyamu akaenzana (angangoita gumi µL) eDiluent, iyo Standard solution uye Test solution muchromatograph uye rekodha machromatogram.Verengai chikamu chekusachena kwega kwega muchikamu cheItraconazole chakatorwa neformula:
100(CS / CU)(rU / rS)
umo CS ndiyo yekuisa, mu mg per mL, yeItraconazole muStandard solution;CU ndiyo chiyero, mu mg per mL, yeItraconazole muChiedza chekuedza;rU ndiyo nzvimbo yepamusoro yekusachena yega yega muyedzo mhinduro;uye rS ndiyo nzvimbo yepamusoro yeItraconazole muStandard solution: kwete kupfuura 0.5% yehupi hupi husina kuchena hunotsanangurwa, sezvinoratidzwa muTebhu 1, inowanikwa;uye kwete kupfuura 1.25% yetsvina yose inowanikwa.Rega chero peak yakaonekwa muDiluent uye chero yepamusoro isingasviki 0.05%.
Tafura 1
Common Name Limit (%)
4-Methoxy derivative1 0.5
4-Triazolyl isomer2 0.5
Propyl analog3 0.5
Isopropyl analog4 0.5
Epimer5 0.5
n-Butyl isomer6 0.5
Didioxolanyl analog7 0.5
1 2-sec-Butyl-4-{4--[4-(4-methoxyphenyl)piperazin-1-yl]phenyl}-2H-1,2,4-triazol-3(4H)-imwe.
2 4-(4-{4--[4-({(2RS,4SR))-2-[(4H-1,2,4-Triazol-4-yl)methyl]-2-(2,4-dichlorophenyl) -1,3-dioxolan-4-yl}methoxy)phenyl]piperazin-1-yl}phenyl)-2-sec-butyl-2H-1,2,4-triazol-3(4H) -one.
3 4-(4-{4--[4-({(2RS,4SR))-2-[(1H-1,2,4-Triazol-1-yl)methyl]-2-(2,4-dichlorophenyl) -1,3-dioxolan-4-yl}methoxy)phenyl]piperazin-1-yl}phenyl)-2-propyl-2H-1,2,4-triazol-3(4H)-imwe.
4 4-(4-{4--[4-({(2RS,4SR))-2-[(1H-1,2,4-Triazol-1-yl)methyl]-2-(2,4-dichlorophenyl) -1,3-dioxolan-4-yl}methoxy)phenyl]piperazin-1-yl}phenyl)-2-isopropyl-2H-1,2,4-triazol-3(4H) -one.
5 4-(4-{4--[4-({(2 chelating agents. RS,4RS)-2--[(1H-1,2,4-Triazol-1-yl)methyl]-2-(2, 4-dichlorophenyl)-1,3-dioxolan-4-yl}methoxy)phenyl]piperazin-1-yl}phenyl)-2-sec-butyl-2H-1,2,4-triazol-3(4H)-one .
6 4-(4-{4--[4-({(2RS,4SR))-2-[(1H-1,2,4-Triazol-1-yl)methyl]-2-(2,4-dichlorophenyl) -1,3-dioxolan-4-yl}methoxy)phenyl]piperazin-1-yl}phenyl)-2-butyl-2H-1,2,4-triazol-3(4H)-imwe.
7 4-(4-{4--[4-({(2RS,4SR))-2-[(1H-1,2,4-Triazol-1-yl)methyl]-2-(2,4-dichlorophenyl) -1,3-dioxolan-4-yl}methoxy)phenyl]piperazin-1-yl}phenyl)-2-({(2RS,4SR)-2-[(1H-1,2,4-triazol-1-) yl)methyl]-2-(2,4-dichlorophenyl) -1,3-dioxo-lan-4-yl}methyl)-2H-1,2,4-triazol-3(4H) -imwe.
Kuongorora-
Diluent-Gadzirira musanganiswa wemethyl ethyl ketone uye glacial acetic acid (7: 1).
Maitiro-Dissolve nezve 0.3 g yeItraconazole, yakanyatsoyerwa, mu70 ml yeDiluent.Titrate ne 0.1 M per chloric acid, inotarisa magumo potentiometrically pane yechipiri inflection point.Imwe mL ye0.1 M per chloric acid yakaenzana ne35.3 mg yeC 35H38Cl2N8O4.