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

Itraconazole ha e na ka tlaase ho karolo ea 98,5 lekholong le ho feta karolo ea 101.5 lekholong ea C35H38Cl2N8O4, e baloang motheong o omisitsoeng.
Ho paka le ho boloka-Ho boloka ka har'a lijana tse thata, tse manganga, 'me u boloke mocheso oa kamore.
USP Reference standards <11>-
USP Itraconazole RS
USP Miconazole RS
Boitsebiso-
A: Infrared Absorption <197K>.
Angular rotation <781A>: pakeng tsa -0.10 ° le +0.10 °, e lekantsoeng ho 20 °
Tharollo ea teko: 100 mg ka mL, ka methylene chloride
Sebaka sa ho qhibiliha <741>: pakeng tsa 166 ° le 170 °
Ho lahleheloa ke ho omisa <731> -Omisa hoo e ka bang 1 g ho 105 ° bakeng sa lihora tse 4: e lahleheloa ke ho feta 0.5% ea boima ba eona.
Masala a ho khantša <281>: eseng ho feta 0.1%, e khethiloeng ka 1.0 g.
Likopano tse amanang-
Tharollo A: 0.08 M tetrabutylammonium hydrogen sulfate.
Tharollo B: acetonitrile
Diluent-Lokisetsa motsoako oa methanol le tetrahydrofuran (1: 1).
Tharollo e tloaelehileng-Hlakola tekanyo e lekantsoeng e nepahetseng ea USP Itraconazole RS ka Diluent, ha ho hlokahala y, ho fumana tharollo e nang le motsoako o tsejoang oa hoo e ka bang 0.05 mg ka mL.
Resolution solution-Hlakola litekanyo tse loketseng tsa USP Itraconazole RS le USP Miconazole ho RS in Diluent ho fumana tharollo e nang le metsoako e ka bang 0.05 mg ka mL.
Tharollo ea teko-Hlakola sekala se lekantsoeng ka nepo sa Itraconazole ka har'a Diluent ho fumana tharollo e nang le motsoako o tsebahalang oa 10 mg ka mL.
Chromatographic system (sheba Chromatography <621>) -Mokelikeli oa chromatograph o na le mochine oa 225-nm le kholomo ea 4.6-mm × 10-cm e nang le 3- μm packing L1.Sekhahla sa phallo ke hoo e ka bang 1.5 mL ka motsotso.Mocheso oa litšiea o bolokiloe ka 30 °.Chromatograph e hlophisitsoe ka tsela e latelang
Nako Tharollo A Tharollo B
(metsotso) (%) (%) Elution
0–20 80→50 20→50 mothalo o mothalo
20–25 50 50 ea boikemelo
25–30 80 20 tekano
[HLOKOMELA-Ekahanya kholomo bonyane metsotso e 30 ka acetonitrile ka sekhahla sa phallo ea 1.5 mL ka motsotso ebe o leka-lekanya sebopeho sa pele sa bonyane metsotso e 5.]
Chromatograph Tharollo ea Qeto, 'me u tlalehe likarabo tsa tlhōrō joalokaha li laetsoe bakeng sa Tsamaiso: qeto, R, pakeng tsa miconazole le itraconazole ha e ka tlaase ho 2.0.
Ts'ebetso-Ka karohano kenya meqolo e lekanang (e ka bang 10 µL) ea Diluent, Tharollo e Tloaelehileng le Tharollo ea Teko ka har'a chromatograph ebe o rekota chromatogram.Bala peresente ea ho se hloeke ka 'ngoe karolong ea Itraconazole e nkiloeng ka foromo:
100(CS / CU)(rU / rS)
moo CS e leng teng, ka mg ka mL, ea Itraconazole ka tharollo e tloaelehileng;CU ke mahloriso, ka mg ka mL, ea Itraconazole ka tharollo ea Tlhahlobo;rU ke sebaka se phahameng sa ho se hloeke ka 'ngoe ho tharollo ea Tlhahlobo;'me rS ke sebaka sa tlhōrō ea Itraconazole ka tharollo e tloaelehileng: eseng ho feta 0.5% ea litšila leha e le life tse boletsoeng, joalokaha ho bontšitsoe Lethathamong la 1, ho fumanoa;mme ha se fete 1.25% ya ditshila kaofela tse fumanwang.Hlokomoloha tlhoro efe kapa efe e bonoang ho Diluent le tlhoro efe kapa efe e ka tlase ho 0.05%.
Lethathamo la 1
Common Name Limit (%)
4-Methoxy derivative1 0.5
4-Triazolyl isomer2 0.5
Analog ea propyl 3 0.5
Analog ea isopropyl 4 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)-one.
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)-one.
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)-one.
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) -ngoe.
Tlhahlobo-
Diluent-Lokisetsa motsoako oa methyl ethyl ketone le glacial acetic acid (7:1).
Ts'ebetso-Hlakola hoo e ka bang 0,3 g ea Itraconazole, e lekantsoeng hantle, ka 70 ml ea Diluent.Titrate ka 0.1 M ka chloric acid, e khethollang ntlha ea ho qetela ka potentiometrically sebakeng sa bobeli sa inflection.ML e le 'ngoe ea 0.1 M ka chloric acid e lekana le 35.3 mg ea C 35H38Cl2N8O4.