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

Itraconazole ili ndi osachepera 98.5 peresenti komanso osapitirira 101.5 peresenti ya C35H38Cl2N8O4, yowerengedwa pa zouma.
Kuyika ndi kusunga-Sungani zotengera zolimba, zosagwira kuwala, ndikusunga kutentha.
Miyezo yolozera ya USP <11>-
USP Itraconazole RS
USP Miconazole RS
Chizindikiritso-
A: Infrared mayamwidwe <197K>.
Kuzungulira kwa angular <781A>: pakati pa -0.10 ° ndi +0.10 °, kuyeza pa 20 °
Njira yothetsera mayeso: 100 mg pa mL, mu methylene chloride
Kusungunuka <741>: pakati pa 166 ° ndi 170 °
Kutaya pakuyanika <731> -Kuwumitsa pafupifupi 1 g pa 105 ° kwa maola 4: imataya osapitirira 0,5% ya kulemera kwake.
Zotsalira pakuyatsa <281>: osapitirira 0.1%, zotsimikizika pa 1.0 g.
Zogwirizana nazo-
Yankho A: 0.08 M tetrabutylammonium hydrogen sulfate.
Njira B: acetonitrile
Diluent-Konzani chisakanizo cha methanol ndi tetrahydrofuran (1: 1).
Sungunulani muyezo woyezera bwino wa USP Itraconazole RS mu Diluent, pang'onopang'ono ngati pakufunika y, kuti mupeze yankho lodziwika bwino la pafupifupi 0.05 mg pa mL.
Resolution solution-Sungani milingo yoyenera ya USP Itraconazole RS ndi USP Miconazole mu RS mu Diluent kuti mupeze yankho lodziwika bwino la pafupifupi 0.05 mg iliyonse pa ml.
Sungunulani muyeso woyezera bwino wa Itraconazole mu Diluent kuti mupeze yankho lodziwika bwino la 10 mg pa ml.
Chromatographic system (onani Chromatography <621>) - Chromatograph yamadzimadzi imakhala ndi chowunikira cha 225-nm ndi ndime ya 4.6-mm × 10-cm yomwe ili ndi 3- μm yonyamula L1.Kuthamanga kwa madzi ndi pafupifupi 1.5 ml pa mphindi.The mzati kutentha anakhalabe pa 30 °.Chromatograph imapangidwa motere
Time Solution A Solution B
(mphindi) (%) (%) Elution
0–20 80→50 20→50 mzere wa mzere
20–25 50 50 isocratic
25–30 80 20 kulinganiza
[DZIWANI-Kulinganiza ndime kwa mphindi zosachepera 30 ndi acetonitrile pamlingo wothamanga wa 1.5 ml pa mphindi ndiyeno fananizani pakupanga koyambirira kwa mphindi zosachepera 5.]
Chromatograph yankho la Resolution, ndipo lembani mayankho apamwamba monga momwe adayankhira Njira: chisankho, R, pakati pa miconazole ndi itraconazole sichichepera 2.0.
Kachitidwe-Payokha jekeseni ma voliyumu ofanana (pafupifupi 10 µL) a Diluent, Standard solution ndi Test solution mu chromatograph ndikujambulitsa ma chromatogram.Werengani kuchuluka kwa zodetsa zilizonse mu gawo la Itraconazole zomwe zatengedwa motsatira ndondomekoyi:
100(CS / CU)(rU / rS)
momwe CS ndi ndende, mu mg pa mL, ya Itraconazole mu Standard solution;CU ndiye ndende, mu mg pa mL, ya Itraconazole mu Mayeso;rU ndiye malo okwera pachidebe chilichonse munjira yoyesera;ndipo rS ndi malo apamwamba kwambiri a Itraconazole mu Standard solution: osapitirira 0.5% ya zonyansa zilizonse, monga momwe tawonetsera mu Table 1, imapezeka;ndipo zosaposa 1.25% ya zonyansa zonse zimapezeka.Musanyalanyaze nsonga iliyonse yomwe yawonedwa mu Diluent komanso pachimake chilichonse chochepera 0.05%.
Table 1
Common Name Limit (%)
4-Methoxy yochokera ku 1 0.5
4-Triazolyl isomer2 0.5
Analogi ya Propyl 3 0.5
Isopropyl analog 4 0.5
Epimer5 0.5
n-Butyl isomer6 0.5
Didioxolanyl analog 7 0.5
1 2-sec-Butyl-4-{4-[4-(4-methoxyphenyl)piperazin-1-yl]phenyl}-2H-1,2,4-triazol-3(4H)-imodzi.
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) -imodzi.
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) -imodzi.
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)-imodzi.
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)-imodzi.
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) -imodzi.
Kuyesa-
Diluent-Konzani chisakanizo cha methyl ethyl ketone ndi glacial acetic acid (7: 1).
Njira-Sungani pafupifupi 0,3 g ya Itraconazole, yoyezedwa molondola, mu 70 ml ya Diluent.Titrate ndi 0.1 M pa chloric acid, kudziwa mapeto potentiometrically pa yachiwiri inflection mfundo.ML imodzi ya 0.1 M pa chloric acid ndi yofanana ndi 35.3 mg ya C 35H38Cl2N8O4.