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

ʻAʻole i emi iho ka Itraconazole ma lalo o 98.5 pākēneka a ʻaʻole ʻoi aku ma mua o 101.5 pākēneka o C35H38Cl2N8O4, i helu ʻia ma ke kumu maloʻo.
Hoʻopili a mālama ʻia - mālama i loko o nā pahu paʻa māmā, a mālama i ka lumi wela.
Nā kūlana hōʻike USP <11>-
USP Itraconazole RS
USP Miconazole RS
ʻike-
A: Infrared Absorption <197K>.
ʻO ka huli ʻana o ka angular <781A>: ma waena o -0.10° a me +0.10°, ana ʻia ma 20°
Hoʻoholo hoʻāʻo: 100 mg no ka mL, i loko o ka methylene chloride
Māhele heheʻe <741>: ma waena o 166° a me 170°
Nalo ma ka maloo <731>-Moloo ma kahi o 1 g ma 105° no 4 mau hola: ʻaʻole e nalowale ma mua o 0.5% o kona kaumaha.
Ke koena ma ka ʻāʻī <281>: ʻaʻole i ʻoi aku ma mua o 0.1%, hoʻoholo ʻia ma 1.0 g.
Huipuia pili-
Hoʻonā A: 0.08 M tetrabutylammonium hydrogen sulfate.
Pane B: acetonitrile
Diluent-Hoʻomākaukau i kahi hui o ka methanol a me ka tetrahydrofuran (1: 1).
ʻO ka hoʻonā maʻamau-E hoʻopau i ka nui o ka USP Itraconazole RS i kaupaona pono ʻia ma ka Diluent, i ka ʻanuʻu ʻana inā pono, e loaʻa i kahi hopena i ʻike ʻia ma kahi o 0.05 mg no ka mL.
Hoʻoholo hoʻonā-E hoʻoheheʻe i nā nui kūpono o USP Itraconazole RS a me USP Miconazole ma RS i Diluent no ka loaʻa ʻana o kahi hopena i ʻike ʻia ma kahi o 0.05 mg kēlā me kēia mL.
Hoʻonā hoʻāʻo-Hoʻoheheʻe i ka nui o ka Itraconazole i kaupaona pono ʻia ma ka Diluent e loaʻa ai kahi hopena i ʻike ʻia ma kahi o 10 mg no ka mL.
Pūnaehana Chromatographic (e nānā i ka Chromatography <621>)-Ua hoʻolako ʻia ka chromatograph wai me kahi mea ʻike 225-nm a me kahi kolamu 4.6-mm × 10-cm i loaʻa iā 3- μm packing L1.ʻO ka nui o ke kahe ʻana he 1.5 mL i kēlā me kēia minuke.Mālama ʻia ka mahana o ke kolamu ma 30 °.Hoʻolālā ʻia ka chromatograph penei
Hoʻoholo manawa A Haʻina B
(mau minuke) (%) (%) Elution
0–20 80→50 20→50 kaha kaha laina
20–25 50 50 hoʻokalakupua
25–30 80 20 kaulike
[NOTE-E hoʻohālikelike i ke kolamu no ka liʻiliʻi o 30 mau minuke me ka acetonitrile ma kahi kahe kahe o 1.5 mL i kēlā me kēia minuke a laila e hoʻohālikelike i ka haku mele mua no 5 mau minuke.]
Chromatograph the Resolution solution, a hoʻopaʻa i nā pane kiʻekiʻe e like me ke kuhikuhi ʻana no ke Kaʻina Hana: ʻo ka hoʻonā, R, ma waena o ka miconazole a me ka itraconazole ʻaʻole i emi iho ma mua o 2.0.
Ke Kaʻina Hana-Hoʻokaʻawale i nā puke like (ma kahi o 10 µL) o ka Diluent, ka solution Standard a me ka solution Test i loko o ka chromatograph a hoʻopaʻa i nā chromatograms.E helu i ka pākēneka o kēlā me kēia haumia i loko o ka ʻāpana o Itraconazole i lawe ʻia e ke kumu:
100(CS / CU)(rU / rS)
i loko o ka CS ka manaʻo, i ka mg per mL, o Itraconazole i loko o ka hopena maʻamau;ʻO CU ka hoʻopaʻa ʻana, ma ka mg o ka mL, o Itraconazole i loko o ka hopena Hoʻāʻo;ʻO rU ka wahi kiʻekiʻe no kēlā me kēia haumia i loko o ka hopena Ho'āʻo;a ʻo rS ka wahi kiʻekiʻe no ka Itraconazole ma ka solution Standard: ʻaʻole i ʻoi aku ma mua o 0.5% o nā haumia i kuhikuhi ʻia, e like me ka hōʻike ʻana ma ka Papa 1, loaʻa;a ʻaʻole ʻoi aku ma mua o 1.25% o ka nui o nā haumia i loaʻa.E mālama ʻole i kekahi peak i ʻike ʻia ma ka Diluent a me kekahi peak ma lalo o 0.05%.
Papa 1
Ka palena inoa maʻamau (%)
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.
hoʻāʻo-
Diluent-Hoʻomākaukau i ka hui ʻana o ka methyl ethyl ketone a me ka ʻakika acetic glacial (7:1).
Kaʻina hana-Dissolve ma kahi o 0.3 g o Itraconazole, i kaupaona pono ʻia, ma 70 ml o Diluent.E hoʻokaʻawale me 0.1 M no kēlā me kēia ʻakika chloric, e hoʻoholo ana i ka hopena hopena ma ke kiko hoʻololi ʻelua.Hoʻokahi mL o 0.1 M no kēlā me kēia waikawa chloric ua like ia me 35.3 mg o C 35H38Cl2N8O4.