Ranitidine Hydrochloride CAS 66357-59-3 Assay 97.5~102.0%

Ranitidine Hydrochloride
C13H22N4O3S·HCl 350.87
1,1-Ethenediamine, N-[2-[[[5-[(dimethylamino)methyl]-2-furanyl]-methyl]thio]ethyl]-N¢-methyl-2-nitro-, monohydrochloride.
N-[2-[[[5-[(Dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N¢-methyl-2-nitro-1,1-ethenediamine, hydrochloride [66357-59-3 ].
Ko te Ranitidine Hydrochloride he iti iho i te 97.5 paiheneti, kaua hoki e neke ake i te 102.0 paiheneti o C13H22N4O3S·HCl, kua tatauhia i runga i te whakamaroke.
Te takai me te rokiroki-Whakaorangia i roto i nga ipu kikii, marama-ātete.
Paerewa Tohutoro USP <11>-
USP Ranitidine Hydrochloride RS
USP Ranitidine Resolution Mixture RS
He ranunga o te ranitidine hydrochloride me nga poke e wha e pa ana: ranitidine-N-oxide, ranitidine complex nitroacetamide, ranitidine diamine hemifumarate, me te ranitidine amino alcohol hemifumarate.
Ranitidine-N-oxide: N,N-dimethyl[5-[[[2-[[1-(methylamino)-2-nitroethenyl]amino]ethyl]sulphanyl]methyl]furan-2-yl]methanamine N-oxide.
Ranitidine complex nitroacetamide: N-[2-[[[5-[(dimethylamino)methyl]furan-2-yl]methyl]sulphanyl]ethyl]-2-nitroacetamide.
Ranitidine diamine hemifumarate (pūhui A): 5-[[(2-aminoethyl)thio]methyl]-N,N-dimethyl-2-furanmethanamine, te tote hemifumarate.
Ranitidine amino alcohol hemifumarate: [5-[(dimethylamino)methyl]furan-2-yl]methanol.
Tautuhinga-
A: Whakangao Infrared <197M>.
B: Te Whakakorikori Ultraviolet <197U>-
Rongoā: 10 µg ia mL.
Waenga: wai.
Ko nga whakaurunga i te 229 nm me te 315 nm, ka tatauhia i runga i te whakamaroke, kaore e rereke atu i te 3.0%.
C: Ka tutuki tetahi otinga ki nga whakaritenga o nga whakamatautau mo Chloride <191>.
pH <791>: i waenganui i te 4.5 me te 6.0, i roto i te otinga (1 i roto i te 100).
Ngaronga i runga i te whakamaroke <731>-Me whakamaroke ki te korehau i te 60 mo te 3 haora: kaua e ngaro atu i te 0.75% o tona taumaha.
Te toenga i runga i te mura <281>: kaua e neke ake i te 0.1%.
Pure Chromatographic-
Diluent, Waahanga Waea Pukoro, otinga Whakatau, me te punaha Chromatographic-Haere tonu i roto i te Whakatau.
otinga Paerewa-Whakaritea rite whakahaua mo te whakarite Paerewa i roto i te Assay.
Whakamātautau otinga-Whakaritea rite whakahaua mo te whakarite Whakamātautau i roto i te Assay.
Tikanga-Tukuhia wehe nga pukapuka rite (mo te 10 µL) o te otinga Paerewa me te otinga Whakamatau ki te chromatograph, tuhia nga chromatograms, me te tautuhi i te tihi ranitidine me nga tihi na te poke me nga hua whakaheke kua whakarārangihia ki te ripanga i raro nei.
Ingoa Wā Pupuri Whanaunga
Ranitidine nitroacetamide ngawari1 0.14
Ranitidine oxime2 0.21
Ranitidine amino alcohol3 0.45
Ranitidine diamine4 0.57
Ranitidine S-oxide5 0.64
Ranitidine N-oxide6 0.72
Ranitidine matatini nitroacetamide7 0.84
Ranitidine formaldehyde tāpiri8 1.36
Ranitidine bis-compound9 1.75
1 N-Methyl-2-nitroacetamide.
2 3-(Methylamino)-5,6-dihydro-2H-1,4-thiazin-2-one oxime.
3 {5-[(Dimethylamino)methyl]furan-2-yl}methanol.
4 5- {[(2-Aminoethyl)thio]methyl}-N,N-dimethyl-2-furanmethanamine (pūhui pā ana ki te ranitidine A).
5 N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N¢-methyl-2-nitro-1,1-ethenediamine (pūhui e pā ana ki te ranitidine C).
6 N,N-Dimethyl(5-{[(2-{[1-(methylamino)-2-nitroethenyl]amino}ethyl)
sulphanyl]methyl}furan-2-yl)methanamine N-oxide.
7 N-{2-[({5-[(Dimethylamino)methyl]furan-2-yl}methyl)sulphanyl]ethyl}-2-nitroacetamide.
8 2,2¢-Methylenebis(N-{2-[({5-[(dimethylamino)methyl]furan-2-yl}methyl)sulphanyl]ethyl}-N¢-methyl-2-nitroethene-1,1- diamine).
9 N,N¢-bis{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)thio]ethyl}-2-nitro-1,1-ethenediamine (pūhui e pā ana ki te ranitidine B).
Inehia nga whakautu mo nga tihi nui, me te tatau i te ōrau o ia poke i te wahanga o te Ranitidine Hydrochloride i tangohia e te tauira:
100CV/W(ri / rS)
ko C te kukū, i te mg ia mL, o te ranitidine hydrochloride i roto i te otinga Paerewa;Ko V te rōrahi, i roto i te mL, o te otinga Whakamātautau;Ko W te taumaha, i te mg, o Ranitidine Hydrochloride i tangohia hei whakarite i te otinga Whakamatau;ri ko te whakautu teitei mo ia poke i puta mai i te otinga Whakamatau;a ko rS te whakautu tihi ranitidine i puta mai i te otinga Paerewa: kaua e neke ake i te 0.3% o te ranitidine bis-compound ka kitea, kaua e neke ake i te 0.1% o tetahi atu poke kotahi ka kitea, kaua e neke ake i te 0.5% o nga poke katoa ka kitea. .Ko te taumata korero mo nga poke he 0.05%.
whakamātautau-
Puawai Phosphate-Tuhia te 1900 mL o te wai ki roto i te ipu rōrahi 2.0-L, tāpiri tika te 6.8 mL waikawa ūkuikui, ka uru.Me tika te taapiri i te 8.6 mL o te 50% wairewa konutai waikawa, ka waimeha ki te wai ki te rōrahi.Mena e tika ana, whakatikahia me te 50% te wairewa konutai waikawa, te waikawa phosphoric ranei ki te pH 7.1, ka tātari.
Otinga A-Whakaritea he ranunga o te parapara Phosphate me te acetonitrile (98:2).
Otinga B-Whakaritea he ranunga o te parapara Phosphate me te acetonitrile (78:22).
Waahanga pūkoro-Whakamahia nga ranunga rereke o te Rongoa A me te Otinga B e kiia ana mo te punaha Chromatographic.Whakaritea nga whakarereketanga mehemea e tika ana (tirohia te Tikanga Pūnaha i raro i te Chromatography 621).
Rongoa-Whakamahia Wairewa A.
Whakariterite Paerewa-Warekahia te rahinga tika o te USP Ranitidine Hydrochloride RS i roto i te Diluent kia whiwhi ai i tetahi otinga e mohiotia ana ko te 0.125 mg o te ranitidine hydrochloride mo ia mL.
Wairewa Whakatau-Whakawhitihia te 1.3 mg o te USP Ranitidine Resolution Mixture RS ki te ipu 10-mL, ka memeha ki roto ka waimeha ki te Diluent ki te rōrahi.[note—Ko te USP Ranitidine Resolution Mixture RS kei roto ko te ranitidine hydrochloride me nga poke e wha e pa ana: ranitidine amino alcohol hemifumarate, ranitidine diamine hemifumarate, ranitidine N-oxide, me te ranitidine complex nitroacetamide.]
Te whakarite whakamatautau-Whakawhitihia te 25 mg o te Ranitidine Hydrochloride, i ata paunatia, ki te ipu 200-mL.Whakarewa ki roto ka waimeha ki te Diluent ki te rōrahi, ka uru.
Pūnaha Chromatographic (tirohia te Chromatography <621>)-Ko te chromatograph wai he mea rite ki te 230-nm kaitahuri me te 4.6-mm × 10-cm tīwae kei roto 3.5-µm whakakī L1 e pūmau ana mai i te pH 1 ki te 12. Ko te tere rere he āhua 1.5 mL ia meneti.Ka mau tonu te mahana o te pou ki te 35. Ko te chromatograph te whakatakotoranga penei.
Wā (mēneti) Rongoā A (%) Rongoā B (%) Elution
0-10 100®0 0®100 rōnaki rārangi
10-15 0 100 whakatiki
15-16 0®100 100®0 rōnaki rārangi
16-20 100 0 re-equilibrationChromatograph the Resolution solution, ka tautuhi i nga tihi ma te whakamahi i te ripanga o nga poke me nga hua whakaheke (kua kitea i runga ake nei): ko te taumira, R, i waenga i nga tihi mo te ranitidine N-oxide me te ranitidine complex nitroacetamide he iti iho i te 1.5.Chromatograph te Whakariterite Paerewa, ka tuhi i nga whakautu teitei i runga i te tohutohu mo te Tikanga: ko te inenga paerewa mo nga werohanga tukurua kaua e neke ake i te 1.0%.
Tikanga-Tukuhia wehe nga pukapuka rite (e tata ana ki te 10 µL) o te whakaritenga Paerewa me te whakareri Assay ki te chromatograph, tuhia nga chromatograms, me te ine i nga waahi mo nga tihi nui.Tātaihia te ōrau o C13H22N4O3S·HCl i te wāhanga o te Ranitidine Hydrochloride i tangohia e te tātai:
100(CS / CU)(rU / rS)
kei roto ko te CS me te CU nga kukū, i te mg ia mL, o te ranitidine hydrochloride i roto i te whakaritenga Paerewa me te whakarite Whakamatau, ia;me rU me rS nga whakautu teitei i puta mai i te whakaritenga Whakatau me te whakaritenga Paerewa.