Itraconazole CAS 84625-61-6 Su'ega 98.5~101.5%

Itraconazole e le itiiti ifo i le 98.5 pasene ae le sili atu i le 101.5 pasene ole C35H38Cl2N8O4, fuafua ile fa'amago.
Fa'apipi'i ma le teuina-fa'asa'o i totonu o atigipusa fufusi, malamalama, ma teu i le vevela o le potu.
USP Reference standards <11>-
USP Itraconazole RS
USP Miconazole RS
Fa'ailoa-
A: Infrared absorption <197K>.
Ta'amilosaga fa'akomu <781A>: i le va o le -0.10° ma le +0.10°, fua ile 20°
Su'ega fofo: 100 mg i le mL, ile methylene chloride
Lisi fa'afefe <741>: i le va o le 166° ma le 170°
Ma'imau ile fa'amago <731>-Fa'amago e tusa ma le 1 g i le 105° mo le 4 itula: e le sili atu i le 0.5% o lona mamafa e leiloa.
Toega i luga o le afi <281>: e le sili atu nai lo le 0.1%, faʻamoemoe ile 1.0 g.
Fa'atasiga fa'atasi-
Fofo A: 0.08 M tetrabutylammonium hydrogen sulfate.
Fofo B: acetonitrile
Diluent-Sauni se paluga o le methanol ma le tetrahydrofuran (1: 1).
Fofo masani-Fa'amuta se aofa'i sa'o o le fuaina o le USP Itraconazole RS i le Diluent, fa'asolosolo fa'asolosolo pe a mana'omia y, e maua ai se vaifofo e iloa ai le fa'atonuga e tusa ma le 0.05 mg i le mL.
Fa'ai'uga fofo-Fa'amuta le aofa'i talafeagai o le USP Itraconazole RS ma le USP Miconazole i le RS i le Diluent e maua mai ai se vaifofo e iloa fa'atonuga e tusa ma le 0.05 mg i le mL.
Fofo o le su'ega-Fa'ata'ape le aofa'i sa'o o le Itraconazole i totonu o le Su'ega e maua ai se vaifofo e iloa ai le 10 mg i le mL.
Chromatographic system (silasila Chromatography <621>)-O le vai chromatograph ua faʻapipiʻiina i se 225-nm detector ma se 4.6-mm × 10-cm koluma o loʻo i ai le 3- μm faʻapipiʻi L1.Ole fua ole tafe e tusa ma le 1.5 mL ile minute.O le vevela o le koluma e tumau pea ile 30 °.Ua fa'apolokalameina le chromatograph e fa'apea
Fofo Taimi A Fofo B
(minute) (%) (%) Elution
0–20 80→50 20→50 gradient laina
20–25 50 50 fa'aisocratic
25–30 80 20 tutusa
[FAAMANATU-Ia fa'afetaui le koluma mo le itiiti ifo i le 30 minute i le acetonitrile i le fua o le tafe o le 1.5 mL i le minute ona fa'amalieina lea i le fa'apipi'i muamua o le eluent mo le itiiti ifo i le 5 minute.]
Chromatograph le Resolution solution, ma faʻamaumau tali pito i luga e pei ona faʻatonuina mo Faiga: o le iugafono, R, i le va o le miconazole ma le itraconazole e le itiiti ifo i le 2.0.
Faiga-Tu'i ese voluma tutusa (tusa ma le 10 µL) o le Diluent, le vaifofo masani ma le vaifofo o le Su'ega i totonu o le chromatograph ma faamaumau le chromatograms.Fa'atusatusa le pasene o mea leaga ta'itasi i le vaega ole Itraconazole e ave ile fua fa'atatau:
100(CS / CU)(rU / rS)
lea o le CS o le faʻatonuga, i le mg i le mL, o le Itraconazole i le vaifofo masani;CU o le faʻatonuga, i le mg i le mL, o le Itraconazole i le Suʻega fofo;rU o le vaega pito i luga o le eleelea taitasi i le vaifofo o le Su'ega;ma le rS o le pito maualuga lea mo le Itraconazole i le vaifofo Tulaga: e le sili atu i le 0.5% o soʻo se faʻamaʻi faʻamaonia, e pei ona faʻaalia i le Laulau 1, o loʻo maua;ma e le sili atu i le 1.25% o le aofaʻi o mea leaga e maua.Fa'aleaogaina so'o se tumutumu o lo'o matauina i le Diluent ma so'o se tumutumu e itiiti ifo i le 0.05%.
Laulau 1
Tapula'a igoa masani (%)
4-Methoxy e maua mai1 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)-tasi.
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)-tasi.
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)-tasi.
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)-tasi.
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)-tasi.
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) -one.
Su'ega-
Diluent-Sauni se paluga o le methyl ethyl ketone ma le glacial acetic acid (7:1).
Fa'ata'otoga-Fa'amuta pe a ma le 0.3 g o le Itraconazole, fa'atatau sa'o, i le 70 ml o le Diluent.Titrate i le 0.1 M ile chloric acid, fuafua le pito i'uga potentiometrically i le tulaga lona lua.O le tasi mL o le 0.1 M i le chloric acid e tutusa ma le 35.3 mg o le C 35H38Cl2N8O4.