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

Itraconazole ya ƙunshi ba kasa da 98.5 bisa dari kuma bai fi 101.5 bisa dari na C35H38Cl2N8O4, lissafta a kan busasshen tushe.
Marufi da ajiya-Ajiye a cikin matsattsu, kwantena masu jure haske, da adanawa a zafin jiki.
Matsayin Magana na USP <11>-
USP Itraconazole RS
USP Miconazole RS
Ganewa-
A: Ciwon Infrared <197K>.
Juyawa na kusurwa <781A>: tsakanin -0.10° da +0.10°, aunawa a 20°
Maganin gwaji: 100 MG kowace ml, a cikin methylene chloride
Kewar narkewa <741>: tsakanin 166° da 170°
Asarar bushewa <731> - bushe game da 1 g a 105 ° na tsawon sa'o'i 4: ya rasa fiye da 0.5% na nauyinsa.
Ragowa akan kunnawa <281>: bai wuce 0.1% ba, an ƙaddara akan 1.0 g.
Abubuwan da ke da alaƙa-
Magani A: 0.08M tetrabutylammonium hydrogen sulfate.
Magani B: acetonitrile
Diluent-Shirya cakuda methanol da tetrahydrofuran (1: 1).
Daidaitaccen bayani-Narkar da adadin USP Itraconazole RS daidai gwargwado a cikin Diluent, mataki-mataki idan ya zama dole y, don samun maganin da yake da sananniya na kusan 0.05 MG kowace ml.
Maganin ƙuduri-Narke dace da yawa na USP Itraconazole RS da USP Miconazole a cikin RS a cikin Diluent don samun maganin sananniya na kusan 0.05 MG kowace ml.
Gwajin maganin-Narke daidai adadin Itraconazole a cikin Diluent don samun maganin da yake da sananniya na kusan MG 10 a kowace ml.
Tsarin Chromatographic (duba Chromatography <621>) -Chromatograph na ruwa yana sanye da na'urar ganowa 225-nm da ginshiƙi na 4.6-mm × 10-cm wanda ya ƙunshi 3- μm packing L1.Matsakaicin kwarara shine kusan 1.5 ml a minti daya.Ana kiyaye zafin jiki na shafi a 30 °.An tsara chromatograph kamar haka
Magani Time A Solution B
(minti) (%) (%) Haske
0–20 80→50 20→50 layin layi
20-25 50 50 masu tsattsauran ra'ayi
25-30 80 20 daidaitawa
[NOTE- Daidaita ginshiƙi na aƙalla mintuna 30 tare da acetonitrile a ƙimar kwarara na 1.5 ml a minti daya sannan a daidaita shi a farkon abun da ke sama na akalla mintuna 5.]
Chromatograph the Resolution solution, da rikodin mafi girman martani kamar yadda aka umurce don Tsara: ƙuduri, R, tsakanin miconazole da itraconazole bai wuce 2.0 ba.
Tsari-Na dabam allura daidai juzu'i (kimanin 10 µL) na Diluent, daidaitaccen bayani da maganin Gwaji a cikin chromatograph da rikodin chromatograms.Yi ƙididdige adadin kowane ƙazanta a cikin ɓangaren Itraconazole da aka ɗauka ta dabara:
100 (CS / CU) (rU / rS)
a cikin abin da CS shine ƙaddamarwa, a cikin mg da ml, na Itraconazole a cikin Mahimmin bayani;CU shine maida hankali, a cikin mg da ml, na Itraconazole a cikin maganin gwajin;rU shine yanki kololuwa ga kowane ƙazanta a cikin maganin gwajin;kuma rS shine yanki mafi girma don Itraconazole a cikin daidaitaccen bayani: bai wuce 0.5% na kowane ƙayyadadden ƙayyadadden ƙayyadadden ƙayyadadden ƙayyadadden ƙayyadadden ƙayyadadden ƙayyadadden ƙayyadadden ƙayyadadden ƙayyadaddun ƙazanta ba, kamar yadda aka nuna a cikin Table 1, an samo shi;kuma ba fiye da 1.25% na jimlar ƙazanta ana samun su ba.Yi watsi da duk wani kololuwar da aka gani a cikin Diluent da kowane kololuwar ƙasa da 0.05%.
Tebur 1
Iyakacin Suna gama gari (%)
4-Methoxy wanda aka samo asali1 0.5
4-Triazolyl isomer2 0.5
Analog na Propyl 3 0.5
Analog na isopropyl 0.5
Epimer 5 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) -daya.
2 4-(4-{4-[4-({(2RS,4SR))-2-[(4H-1,2,4-Triazol-4-yl)methyl]-2-(2,4-dichlorofenyl) -1,3-dioxolan-4-yl}methoxy)phenyl] piperazin-1-yl} phenyl -2-sec-butyl-2H-1,2,4-triazol-3(4H) -daya.
3 4- (4-{4-[4-({(2RS,4SR))-2-[(1H-1,2,4-Triazol-1-yl)methyl]-2- (2,4-dichlorofenyl) -1,3-dioxolan-4-yl}methoxy)phenyl] piperazin-1-yl} phenyl -2-propyl-2H-1,2,4-triazol-3(4H) -daya.
4 4- (4-{4-[4-({(2RS,4SR))-2-[(1H-1,2,4-Triazol-1-yl)methyl]-2- (2,4-dichlorofenyl) -1,3-dioxolan-4-yl}methoxy)phenyl] piperazin-1-yl} phenyl -2-isopropyl-2H-1,2,4-triazol-3(4H) -daya.
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) -daya .
6 4-(4-{4-[4-({(2RS,4SR))-2-[(1H-1,2,4-Triazol-1-yl)methyl]-2-(2,4-dichlorofenyl) -1,3-dioxolan-4-yl}methoxy)phenyl] piperazin-1-yl} phenyl -2-butyl-2H-1,2,4-triazol-3(4H) -daya.
7 4-(4-{4-[4-({(2RS,4SR))-2-[(1H-1,2,4-Triazol-1-yl)methyl]-2-(2,4-dichlorofenyl) -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) -daya.
Assay-
Diluent-Shirya cakuda methyl ethyl ketone da glacial acetic acid (7: 1).
Hanyar-Narke kimanin 0.3 g na Itraconazole, daidai auna, a cikin 70 ml na Diluent.Titrate tare da 0.1 M a kowace chloric acid, yana ƙayyade ƙarshen maƙasudi mai ƙarfi a wurin jujjuyawa na biyu.Ɗayan ml na 0.1 M a kowace chloric acid yana daidai da 35.3 MG na C 35H38Cl2N8O4.