ʻO Ranitidine Hydrochloride CAS 66357-59-3 Hōʻike 97.5 ~ 102.0%

ʻO 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 ].
ʻAʻole i emi iho ka Ranitidine Hydrochloride ma lalo o 97.5 pakeneka a ʻaʻole i oi aku ma mua o 102.0 pakeneka o C13H22N4O3S·HCl, i helu ʻia ma ke kumu maloʻo.
Hoʻopili ʻia a mālama ʻia - mālama ʻia i loko o nā pahu paʻa māmā.
Nā kūlana hōʻike USP <11>-
USP Ranitidine Hydrochloride RS
USP Ranitidine Resolution Mixture RS
He hui ia o ka ranitidine hydrochloride a me nā mea haumia ʻehā e pili ana: ranitidine-N-oxide, ranitidine complex nitroacetamide, ranitidine diamine hemifumarate, a me 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.
ʻO Ranitidine diamine hemifumarate (hui pili A): 5-[[(2-aminoethyl)thio]methyl]-N,N-dimethyl-2-furanmethanamine, paʻakai hemifumarate.
Ranitidine amino alcohol hemifumarate: [5-[(dimethylamino)methyl]furan-2-yl]methanol.
ʻike-
A: Infrared Absorption <197M>.
B: Ultraviolet Absorption <197U>-
Pane: 10 µg no mL.
Waena: wai.
ʻO ka absorptivities ma 229 nm a me 315 nm, i helu ʻia ma ke kumu maloʻo, ʻaʻole ʻokoʻa ma mua o 3.0%.
C: Hoʻokō ka hopena o ia mea i nā koi o nā hoʻokolohua no Chloride <191>.
pH <791>: ma waena o 4.5 a me 6.0, ma kahi hoʻonā (1 i ka 100).
Nalo ma ka maloo <731>-Moloolo ia i loko o ka momi ma 60 no 3 mau hola: ʻaʻole e nalowale ma mua o 0.75% o kona kaumaha.
ʻO ke koena ma ka ʻā ʻana <281>: ʻaʻole ʻoi aku ma mua o 0.1%.
Chromatographic maemae-
Diluent, Mobile phase, Resolution solution, a me Chromatographic system-Hoʻomau e like me ke kuhikuhi ʻana i ka Assay.
Hoʻoponopono maʻamau-Hoʻomākaukau e like me ke kuhikuhi no ka hoʻomākaukau maʻamau i ka Assay.
Hoʻoholo hoʻāʻo-Hoʻomākaukau e like me ka kuhikuhi ʻana no ka hoʻomākaukau ʻana i ka Assay i ka Assay.
Ke Kaʻina Hana - E hoʻokaʻawale i nā puke like (ma kahi o 10 µL) o ka solution Standard a me ka solution Test i loko o ka chromatograph, e hoʻopaʻa i nā chromatograms, a ʻike i ka piko ranitidine a me nā piko ma muli o nā haumia a me nā huahana degradation i helu ʻia ma ka papa ma lalo.
Inoa Manawa Paa Pili
ʻO Ranitidine maʻalahi nitroacetamide1 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
ʻO Ranitidine complex nitroacetamide7 0.84
Hoʻohui ʻia ʻo Ranitidine formaldehyde8 1.36
Ranitidine bis-compound9 1.75
1 N-Methyl-2-nitroacetamide.
2 3-(Methylamino)-5,6-dihydro-2H-1,4-thiazin-2-hoʻokahi oxime.
3 {5-[(Dimethylamino)methyl]furan-2-yl}metanol.
4 5- {[(2-Aminoethyl)thio]methyl}-N,N-dimethyl-2-furanmethanamine (huihui pili ranitidine A).
5 N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N¢-methyl-2-nitro-1,1-ethenediamine (huihui pili 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 (huihui pili ranitidine B).
E ana i nā pane no nā piko nui, a e helu i ka pākēneka o kēlā me kēia haumia i loko o ka māhele o Ranitidine Hydrochloride i lawe ʻia e ke kumu:
100CV/W(ri / rS)
i loko o ka C ka hoʻopaʻa ʻana, ma ka mg o ka mL, o ka ranitidine hydrochloride i loko o ka hopena maʻamau;ʻO V ka leo, ma ka mL, o ka hoʻonā Hoʻāʻo;ʻO W ka paona, ma ka mg, o Ranitidine Hydrochloride i lawe ʻia e hoʻomākaukau i ka hoʻonā Hoʻāʻo;ʻO ri ka pane kiʻekiʻe no kēlā me kēia haumia i loaʻa mai ka hopena hoʻāʻo;a ʻo rS ka pane kiʻekiʻe o ka ranitidine i loaʻa mai ka solution Standard: ʻaʻole i ʻoi aku ma mua o 0.3% o ka ranitidine bis-compound i ʻike ʻia, ʻaʻole i ʻoi aku ma mua o 0.1% o nā mea haumia ʻē aʻe i loaʻa, a ʻaʻole i ʻoi aku ma mua o 0.5% o ka nui o nā haumia i loaʻa. .ʻO ka pae hōʻike no nā haumia he 0.05%.
hoʻāʻo-
Hoʻopaʻa Phosphate-E hoʻokomo ma kahi o 1900 mL o ka wai i loko o ka pahu volumetric 2.0-L, e hoʻohui pono i 6.8 mL o ka waikawa phosphoric, a hui.Hoʻohui pololei i ka 8.6 mL o ka solution sodium hydroxide 50%, a hoʻoheheʻe me ka wai i ka nui.Inā pono, e hoʻololi me 50% sodium hydroxide solution a i ʻole phosphoric acid i kahi pH o 7.1, a kānana.
Pane A-E hoʻomākaukau i ka hui ʻana o Phosphate buffer a me acetonitrile (98:2).
Hoʻonā B-E hoʻomākaukau i ka hui ʻana o ka pāpaʻi Phosphate a me ka acetonitrile (78:22).
ʻĀpana paʻalima-E hoʻohana i nā hui like ʻole o ka Solution A a me ka Solution B e like me ke kuhikuhi ʻana no ka ʻōnaehana Chromatographic.Hana i nā hoʻololi inā pono (e nānā i ka System Suitability ma lalo o Chromatography 621).
ʻO ka hoʻohana ʻana i ka diluent solution A.
Hoʻomākaukau maʻamau-E hoʻoheheʻe i ka nui o ka USP Ranitidine Hydrochloride RS i kaupaona pono ʻia ma ka Diluent e loaʻa ai kahi hopena i ʻike ʻia ma kahi o 0.125 mg o ka ranitidine hydrochloride no ka mL.
Hoʻoholo hoʻoholo-E hoʻoneʻe ma kahi o 1.3 mg o USP Ranitidine Resolution Mixture RS i kahi pahu volumetric 10-mL, a hoʻoheheʻe i loko a hoʻoheheʻe me ka Diluent i ka leo.[nota—USP Ranitidine Resolution Mixture RS aia ka ranitidine hydrochloride a me eha mau haumia pili: ranitidine amino alcohol hemifumarate, ranitidine diamine hemifumarate, ranitidine N-oxide, a me ranitidine complex nitroacetamide.]
Hoʻomākaukau hoʻāʻo-E hoʻoneʻe ma kahi o 25 mg o Ranitidine Hydrochloride, i kaupaona pololei ʻia, i kahi pahu volumetric 200-mL.E hoʻoheheʻe i loko a hoʻoheheʻe me ka Diluent i ka nui, a hui pū.
Pūnaehana Chromatographic (e nānā i ka Chromatography <621>)-Ua hoʻolako ʻia ka chromatograph wai me kahi mea ʻike 230-nm a me kahi kolamu 4.6-mm × 10-cm i loaʻa ka 3.5-µm packing L1 i paʻa mai ka pH 1 a hiki i ka 12. ʻO ke kahe kahe. ma kahi o 1.5 mL i kēlā me kēia minuke.Mālama ʻia ka mahana o ke kolamu ma 35. Hoʻonohonoho ʻia ka chromatograph penei.
Manawa (minuke) Hoʻonā A (%) Haʻina B (%) Elution
0-10 100®0 0®100 kaha kaha laina
10-15 0 100 hoʻokalakupua
15-16 0®100 100®0 kaha kaha laina
16-20. 1.5.Chromatograph i ka hoʻomākaukau maʻamau, a hoʻopaʻa i nā pane kiʻekiʻe e like me ke kuhikuhi ʻana no ke Kaʻina Hana: ʻaʻole ʻoi aku ka ʻokoʻa maʻamau pili no ka hoʻopili hou ʻana ma mua o 1.0%.
Kaʻina hana-Hoʻokaʻawale i nā puke like (ma kahi o 10 µL) o ka hoʻomākaukau maʻamau a me ka hoʻomākaukau ʻana i ka Assay i loko o ka chromatograph, e hoʻopaʻa i nā chromatograms, a ana i nā wahi no nā piko nui.E helu i ka pākēneka o C13H22N4O3S·HCl i loko o ka hapa o ka Ranitidine Hydrochloride i lawe ʻia e ke kumu:
100(CS / CU)(rU / rS)
i loko o ka CS a me ka CU ka hoʻopaʻa ʻana, ma ka mg per mL, o ka ranitidine hydrochloride i ka hoʻomākaukau maʻamau a me ka hoʻomākaukau Assay, kēlā me kēia;a ʻo rU a me rS nā pane kiʻekiʻe i loaʻa mai ka hoʻomākaukau Assay a me ka hoʻomākaukau maʻamau.