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

Kei roto i te Itraconazole kaua e iti iho i te 98.5 paiheneti me te kore e neke ake i te 101.5 paiheneti o C35H38Cl2N8O4, ka tatauhia i runga i te tikanga whakamaroke.
Packaging me te rokiroki-Tiaki i roto i kikī, ipu marama-ātete, me te rokiroki i te pāmahana rūma.
Paerewa Tohutoro USP <11>-
USP Itraconazole RS
USP Miconazole RS
Tautuhinga-
A: Whakangao Infrared <197K>.
Te hurihanga koki <781A>: i waenganui i te -0.10° me te +0.10°, i ine ki te 20°
Te otinga whakamatautau: 100 mg ia mL, i roto i te methylene chloride
Awhe whakarewa <741>: i waenga i te 166° me te 170°
Ngaronga i runga i te whakamaroke <731>-Merohia te 1 g i te 105° mo te 4 haora: ka ngaro te 0.5% o tona taumaha.
Te toenga i runga i te mura <281>: kaua e neke ake i te 0.1%, kua whakatauhia ki te 1.0 g.
Pūhui pā-
Rongoā A: 0.08 M tetrabutylammonium hydrogen sulfate.
Rongoā B: acetonitrile
Diluent-Whakaritea he ranunga o te methanol me te tetrahydrofuran (1:1).
Wairewa Paerewa-Whakarewahia te rahinga tika o te USP Itraconazole RS i roto i te Diluent, i te hikoi mena e tika ana, kia whiwhi ai i tetahi otinga e mohiotia ana he 0.05 mg ia mL.
Wairewa Whakatau-Warekahia nga rahinga tika o te USP Itraconazole RS me te USP Miconazole i roto i te RS i roto i te Diluent kia whiwhi ai i tetahi otinga kua mohiohia he 0.05 mg ia mL.
Whakamātautau otinga-Whakarewa i te rahinga tika paunatia o Itraconazole i Diluent ki te whiwhi i te otinga whai te kukū mohiotia o e pā ana ki 10 mg ia mL.
Pūnaha Chromatographic (tirohia te Chromatography <621>)-Ko te chromatograph wai he mea rite ki te 225-nm kaitahuri me te 4.6-mm × 10-cm tīwae kei roto 3- μm tarapi L1.Ko te tere rere he 1.5 mL ia meneti.Ka mau tonu te pāmahana tīwae ki te 30 °.Ko te chromatograph te mea e whai ake nei
Te Waa Otinga A Otinga B
(meneti) (%) (%) Elution
0–20 80→50 20→50 rōnaki rārangi
20–25 50 50 tito
25–30 80 20 whakaōrite
[FAKATOKANGA-Whakaritea te pou mo te 30 meneti neke atu ki te acetonitrile i te tere rere o te 1.5 mL ia meneti, ka whakataurite ki te titonga rewa tuatahi mo te 5 meneti neke atu.]
Chromatograph the Resolution solution, and record the peak responses as directed for Procedure: te taumira, R, i waenganui i te miconazole me te itraconazole kaua e iti iho i te 2.0.
Tikanga-Tukuhia wehe nga pukapuka rite (mo te 10 µL) o te Diluent, te otinga Paerewa me te otinga Whakamatau ki roto i te chromatograph me te tuhi i nga chromatograms.Tātaihia te ōrau o ia poke i te wahanga o Itraconazole i tangohia e te tauira:
100(CS / CU)(rU / rS)
i roto i te CS ko te kukū, i roto i te mg ia mL, o Itraconazole i roto i te otinga Paerewa;Ko te CU te kukū, i te mg ia mL, o Itraconazole i roto i te otinga Whakamatau;Ko rU te waahi teitei mo ia poke i roto i te otinga Whakamatau;a ko rS te waahi teitei mo te Itraconazole i roto i te otinga Paerewa: kaua e neke ake i te 0.5% o nga poke kua tohua, penei i te Ripanga 1, ka kitea;a kaua e neke ake i te 1.25% o nga poke katoa ka kitea.Kaua e aro ki tetahi tihi ka kitea i roto i te Diluent me tetahi tihi iti iho i te 0.05%.
Ripanga 1
Tepe ingoa noa (%)
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)-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)-one.
whakamātautau-
Diluent-Whakaritea he ranunga o te methyl ethyl ketone me te waikawa acetic glacial (7:1).
Tikanga-Whakarewa mo te 0.3 g o te Itraconazole, tika te pauna, i roto i te 70 ml o te Diluent.Whakatairitea ki te 0.1 M mo ia waikawa maataa, me te whakatau i te pito mutunga ki te ira potiki tuarua.Kotahi mL o te 0.1 M mo ia waikawa maota he rite ki te 35.3 mg o C 35H38Cl2N8O4.