Ranitidine Hydrochloride CAS 66357-59-3 Su'ega 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 ].
Ranitidine Hydrochloride o loʻo i ai e le itiiti ifo i le 97.5 pasene ma e le sili atu i le 102.0 pasene o le C13H22N4O3S·HCl, fuafua i luga o le faʻamago.
Fa'apipi'i ma teu-fa'asa'o i totonu o koneteina fufusi ma mama.
USP Reference standards <11>-
USP Ranitidine Hydrochloride RS
USP Ranitidine Resolution Mixture RS
O se fa'afefiloiga o le ranitidine hydrochloride ma fa'aleaga e fa'atatau i ai: ranitidine-N-oxide, ranitidine complex nitroacetamide, ranitidine diamine hemifumarate, ma le 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 lavelave nitroacetamide: N-[2-[[[5-[(dimethylamino)methyl]furan-2-yl]methyl]sulphanyl]ethyl]-2-nitroacetamide.
Ranitidine diamine hemifumarate (fesoʻotaʻiga A): 5-[[(2-aminoethyl)thio]methyl]-N,N-dimethyl-2-furanmethanamine, masima hemifumarate.
Ranitidine amino alcohol hemifumarate: [5-[(dimethylamino)methyl]furan-2-yl]methanol.
Fa'ailoa-
A: Infrared absorption <197M>.
B: Ultraviolet absorption <197U>-
Fofo: 10 µg ile mL.
Medium: vai.
Absorptivities i le 229 nm ma le 315 nm, fuafua i luga o le faʻamago, e le ese i le sili atu i le 3.0%.
C: O se vaifofo e fetaui ma manaʻoga o suʻega mo Chloride <191>.
pH <791>: i le va o le 4.5 ma le 6.0, i se vaifofo (1 i le 100).
Ma'imau ile fa'amago <731>-Fa'amago i le vacuum ile 60 mo le 3 itula: e le sili atu i le 0.75% o lona mamafa.
Toega ile mu <281>: e le sili atu i le 0.1%.
Chromatographic mama-
Diluent, Vaega feavea'i, Resolution solution, ma Chromatographic system-Faagasolo e pei ona faatonuina i le Su'ega.
Fofo masani-Sauni e pei ona faatonuina mo sauniuniga masani i le Suʻega.
Su'ega fofo-Sauni e pei ona faatonuina mo le Su'ega Su'ega i le Su'ega.
Faiga-Tu'i ese voluma tutusa (pe tusa ma le 10 µL) o le vaifofo Fa'ata'atia ma le Su'ega fofo i totonu o le chromatograph, fa'amaumau chromatograms, ma fa'ailoa le tumutumu o le ranitidine ma le tumutumu ona o mea leaga ma fa'aleagaina o lo'o lisiina i le laulau i lalo.
Igoa Taimi Taofiga
Ranitidine faigofie 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
Ranitidine lavelave nitroacetamide7 0.84
Ranitidine formaldehyde faaopoopo8 1.36
Ranitidine bis-compound9 1.75
1 N-Methyl-2-nitroacetamide.
2 3-(Methylamino)-5,6-dihydro-2H-1,4-thiazin-2-tasi oxime.
3 {5-[(Dimethylamino)methyl]furan-2-yl}methanol.
4 5- {[(2-Aminoethyl)thio]methyl}-N,N-dimethyl-2-furanmethanamine (ranitidine related compound A).
5 N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N¢-methyl-2-nitro-1,1-ethenediamine (ranitidine related compound 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 (ranitidine related compound B).
Fua tali mo tumutumu tetele, ma fuafua le pasene o mea leaga taitasi i le vaega o le Ranitidine Hydrochloride e ave e le fua:
100CV/W(ri/rS)
o le C o le faʻatonuga, i le mg i le mL, o le ranitidine hydrochloride i le vaifofo masani;V o le voluma, i le mL, o le vaifofo o le Su'ega;W o le mamafa, i mg, o le Ranitidine Hydrochloride na ave e saunia ai le vaifofo o le Su'ega;ri o le tali pito i luga mo mea leaga taitasi e maua mai le vaifofo o le Su'ega;ma le rS o le tali pito i luga o le ranitidine e maua mai le vaifofo Tulaga: e le sili atu i le 0.3% o le ranitidine bis-compound e maua, e le sili atu i le 0.1% o soʻo se isi mea leaga e maua, ma e le sili atu i le 0.5% o le aofaʻi o mea leaga e maua. .Ole maualuga ole lipoti mo mea leaga ole 0.05%.
Su'ega-
Fofosa fa'apipi'i-Tu'u pe tusa ma le 1900 mL le vai i totonu o se fagu volumetric 2.0-L, fa'aopoopo sa'o le 6.8 mL o le phosphoric acid, ma fa'afefiloi.Fa'aopopo sa'o le 8.6 mL ole 50% vaifofo ole sodium hydroxide, ma fa'asusu ile vai ile voluma.Afai e manaʻomia, faʻafetaui i le 50% sodium hydroxide solution poʻo le phosphoric acid i le pH o le 7.1, ma faamama.
Fofo A-Sauni se fa'afefiloi ole Phosphate buffer ma le acetonitrile (98:2).
Fofo B-Sauni se fa'afefiloi ole Phosphate buffer ma le acetonitrile (78:22).
Vaega fe'avea'i-Fa'aaogā fa'afefiloi fesuisuia'i o Fofo A ma Fofo B e pei ona fa'atonuina mo le faiga o le Chromatographic.Faia ni fetuunaiga pe a talafeagai (tagai System Suitability i lalo ole Chromatography 621).
Fofo fa'aaogā fa'asuavai A.
Sauniuniga masani-Fa'amuta se aofa'i sa'o le fuaina o le USP Ranitidine Hydrochloride RS i le Diluent e maua ai se vaifofo o lo'o i ai se fa'atonuga iloa e tusa ma le 0.125 mg o le ranitidine hydrochloride i le mL.
Fa'ai'uga fofo-Fa'aliliu pe tusa ma le 1.3 mg o le USP Ranitidine Resolution Mixture RS i se fagu volumetric 10-mL, ma fa'amuta i totonu ma fa'asusu ile Diluent i le voluma.[faamatalaga—USP Ranitidine Resolution Mixture RS o loʻo i ai le ranitidine hydrochloride ma faʻaleagaina e fa: ranitidine amino alcohol hemifumarate, ranitidine diamine hemifumarate, ranitidine N-oxide, ma le ranitidine complex nitroacetamide.]
Sauniuniga su'esu'e- Fa'aliliu pe tusa ma le 25 mg o le Ranitidine Hydrochloride, fa'atatau tonu le mamafa, i se fagu voluma 200-mL.Fa'amuta i totonu ma fa'afefiloi i le Diluent i le voluma, ma fa'afefiloi.
Chromatographic system (silasila Chromatography <621>)-O le chromatograph vai ua faʻapipiʻiina i se 230-nm detector ma se 4.6-mm × 10-cm koluma o loʻo i ai le 3.5-µm faʻapipiʻi L1 lea e mautu mai le pH 1 i le 12. e tusa ma le 1.5 ml i le minute.O le vevela o le koluma e faʻatumauina i le 35. O le chromatograph ua faʻapipiʻiina e pei ona taua i lalo.
Taimi (minute) Fofo A (%) Fofo B (%) Elution
0-10 100®0 0®100 gradient laina
10-15 0 100 fa'aisocratic
15-16 0®100 100®0 gradient laina
16-20 100 0 re-equilibrationChromatograph le Resolution solution, ma faailoa pito i luga e faʻaaoga ai le laulau o mea leaga ma mea faʻaleagaina (maua i luga): o le fofo, R, i le va o tumutumu mo ranitidine N-oxide ma ranitidine complex nitroacetamide e le itiiti ifo i lo 1.5.Chromatograph le Sauniuniga Fa'ata'atia, ma fa'amaumau tali pito i luga e pei ona fa'atonuina mo le Fa'atonuga: ole va'aiga fa'atatau mo tui fa'atusa e le sili atu ile 1.0%.
Faiga-Tu'i ese voluma tutusa (tusa ma le 10 µL) o le sauniuniga Fa'ata'atia ma le Su'ega Su'ega i totonu o le chromatograph, fa'amaumau le chromatograms, ma fua vaega mo tumutumu tetele.Fa'atatau le pasene ole C13H22N4O3S·HCl ile vaega ole Ranitidine Hydrochloride na ave ile fua fa'atatau:
100(CS / CU)(rU / rS)
lea o le CS ma le CU o loʻo i ai faʻatonuga, i mg i le mL, o le ranitidine hydrochloride i le sauniuniga Tulaga masani ma le sauniuniga Suʻega, i le faasologa;ma le rU ma le rS o tali maualuga ia e maua mai le sauniuniga Su'ega ma le sauniuniga Tulaga, i le faasologa.