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

Itraconazole wuxuu ka kooban yahay wax aan ka yarayn 98.5 boqolkiiba oo aan ka badnayn 101.5 boqolkiiba C35H38Cl2N8O4, oo lagu xisaabiyo saldhigga qallalan.
Baakadaha iyo kaydinta-Ku xafid weelasha cidhiidhiga ah, iftiinka u adkaysta, kuna kaydi heerkulka qolka.
Heerarka Tixraaca USP <11>-
USP Itraconazole RS
USP Miconazole RS
Aqoonsiga -
J: Nuugista Infrared <197K>.
Wareega xagal <781A>: inta u dhaxaysa -0.10° iyo +0.10°, lagu qiyaasay 20°
Xalka tijaabada: 100 mg halkii ml, ee methylene chloride
Kala duwanaanta dhalaalaysa <741>: inta u dhaxaysa 166° iyo 170°
Luminta qallajinta <731>-Qalaji qiyaastii 1 g at 105 ° 4 saacadood: waxay luminaysaa wax aan ka badnayn 0.5% miisaankeeda.
Hadhaaga dabka <281>: aan ka badnayn 0.1%, oo lagu go'aamiyay 1.0 g.
Iskudhisyada la xidhiidha-
Xalka A: 0.08 M tetrabutylammonium hydrogen sulfate.
Xalka B: acetonitrile
Diluent- Diyaari isku dhafka methanol iyo tetrahydrofuran (1:1).
Xalka caadiga ah-Ku milmaan tirada saxda ah ee USP Itraconazole RS ee Diluent, si tartiib tartiib ah haddii loo baahdo y, si loo helo xal la og yahay oo ku saabsan 0.05 mg halkii ml.
Xalka xallinta-Milli tirada ku habboon ee USP Itraconazole RS iyo USP Miconazole ee RS ee Diluent si loo helo xal la og yahay oo ku saabsan 0.05 mg midkiiba mL.
Tijaabada xal-ku milmi tirada saxda ah ee la miisaamay ee Itraconazole ee Diluent si aad u hesho xal isagoo uruursan la og yahay oo ku saabsan 10 mg halkii ml.
Nadaamka Chromatographic (eeg Chromatography <621>)-Kromaatograph-ka dareeraha ah waxa uu ku qalabaysan yahay 225-nm detector iyo tiir 4.6-mm × 10-cm ah oo ka kooban 3- μm xirmo L1.Heerka socodka waa qiyaastii 1.5 mL daqiiqadii.Heerkulka tiirka waxaa lagu hayaa 30 °.chromatograph-ka waxa loo habeeyey sidan soo socota
Waqtiga Xalka A Xalka B
(daqiiqado) (%) (%) Elution
0–20 80→50 20→50 jaanis toosan
20-25 50 50 cibaadaysi
25-30 80 20 dheellitirka
[FIIRO GAAR AH-Ku dhig tiirka ugu yaraan 30 daqiiqo oo leh acetonitrile heerka socodka 1.5 mL daqiiqadii ka dibna u dhig halabuurka hore ugu yaraan 5 daqiiqo.]
Chromatograph Xalka Xallinta, oo qor jawaabaha ugu sarreeya sida lagu faray Habka: xallinta, R, inta u dhaxaysa miconazole iyo itraconazole kama yara 2.0.
Habka-Si gooni ah u duri mugga siman (qiyaastii 10 µL) ee dareeraha, xalalka caadiga ah iyo xalka tijaabada chromatograph-ka oo duub chromatogram-yada.Xisaabi boqolkiiba wasakh kasta oo ku jirta qaybta Itraconazole ee ay qaadatay caanaha:
100 (CS / CU) (rU / rS)
taas oo CS ay tahay diiradda, in mg per mL, of Itraconazole ee xalalka Standard;CU waa fiirsashada, ee mg per mL, of Itraconazole ee xalka Imtixaanka;rU waa meesha ugu sarreysa ee wasakh kasta oo ku jirta xalka Imtixaanka;iyo rS waa meesha ugu sarreysa ee Itraconazole ee xalka caadiga ah: in aan ka badnayn 0.5% wasakh kasta oo la cayimay, sida ku cad Shaxda 1, ayaa la helay;oo aan ka badnayn 1.25% wadarta wasakhda la helay.Iska ilaali wax kasta oo ugu sarreeya ee lagu arkay Diluent iyo wax kasta oo ugu sarreeya ee ka yar 0.05%.
Shaxda 1
Xadka Magaca Guud (%)
4-Methoxy derivative1 0.5
4-Triazolyl isomer2 0.5
Analoogga propyl3 0.5
Analoog isopropyl 0.5
Epimer5 0.5
n-Butyl isomer6 0.5
Didioxolanyl analooga7 0.5
1 2-sek-Butyl-4-{4-[4-(4-methoxyphenyl)piperazin-1-yl]phenyl}-2H-1,2,4-triazol-3(4H) -hal.
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-sek-butyl-2H-1,2,4-triazol-3(4H) -hal.
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) -hal.
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) -hal.
5 4-(4-{4-[4-{(2 wakilada. 4-dichlorophenyl)-1,3-dioxolan-4-yl}methoxy)phenyl]piperazin-1-yl}phenyl)-2-sek-butyl-2H-1,2,4-triazol-3(4H)-hal .
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) -hal.
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) -hal.
Imtixaan-
Diluent- Diyaari isku dhafka methyl ethyl ketone iyo glacial acetic acid (7:1).
Habka-Mila qiyaastii 0.3 g of Itraconazole, si sax ah loo miisaamay, gudaha 70 ml oo ah Diluent.Titrate leh 0.1 M halkii chloric acid, go'aaminta barta dhamaadka si awood leh oo ah barta is-rogid ee labaad.Hal ml oo ah 0.1 M halkii kiiloric acid waxay u dhigantaa 35.3 mg ee C 35H38Cl2N8O4.