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 ].
Ranitidine Hydrochloride ni ko kere ju 97.5 ogorun ati pe ko ju 102.0 ogorun ti C13H22N4O3S·HCl, ti a ṣe iṣiro lori ipilẹ ti o gbẹ.
Iṣakojọpọ ati ibi ipamọ-Fipamọ sinu wiwọ, awọn apoti sooro ina.
Awọn ajohunše Itọkasi USP <11>-
USP Ranitidine Hydrochloride RS
USP Ranitidine Ipinnu Adalu RS
O jẹ adalu ranitidine hydrochloride ati awọn aimọ mẹrin ti o ni ibatan: ranitidine-N-oxide, ranitidine complex nitroacetamide, ranitidine diamine hemifumarate, ati 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 eka nitroacetamide: N-[2-[[[5-[(dimethylamino)methyl]furan-2-yl]methyl] sulphanyl] ethyl] -2-nitroacetamide.
Ranitidine diamine hemifumarate (ọpọlọpọ ti o ni ibatan): 5-[[(2-aminoethyl) thio] methyl] -N, N-dimethyl-2-furanmethanamine, iyọ hemifumarate.
Ranitidine amino alcohol hemifumarate: [5-[(dimethylamino)methyl]furan-2-yl] methanol.
Idanimọ-
A: Gbigba infurarẹẹdi <197M>.
B: Gbigba Ultraviolet <197U>-
Solusan: 10 µg fun milimita kan.
Alabọde: omi.
Absorptivities ni 229 nm ati 315 nm, iṣiro lori ipilẹ ti o gbẹ, ko yatọ nipasẹ diẹ sii ju 3.0%.
C: Ojutu rẹ pade awọn ibeere ti awọn idanwo fun Chloride <191>.
pH <791>: laarin 4.5 ati 6.0, ni ojutu kan (1 ni 100).
Pipadanu lori gbigbe <731>-Gbẹ ni igbale ni 60 fun wakati 3: ko padanu diẹ sii ju 0.75% ti iwuwo rẹ.
Aloku lori ina <281>: ko ju 0.1%.
Kromatographic mimọ-
Diluent, Alakoso Alagbeka, Ojutu ipinnu, ati eto Chromatographic-Tẹsiwaju bi a ti ṣe itọsọna ninu Assay.
Ojutu Standard-Mura bi a ti ṣe itọsọna fun igbaradi Standard ni Assay.
Idanwo ojutu-Murasilẹ bi a ti ṣe itọsọna fun igbaradi Assay ni Ayẹwo.
Ilana-Lọtọ ara awọn iwọn dogba (nipa 10 µL) ti ojutu Standard ati ojutu Idanwo sinu chromatograph, ṣe igbasilẹ awọn chromatogram, ati ṣe idanimọ tente oke ranitidine ati awọn oke giga nitori awọn aimọ ati awọn ọja ibajẹ ti a ṣe akojọ si ni tabili ni isalẹ.
Orukọ Aago Idaduro ibatan
Ranitidine rọrun nitroacetamide1 0.14
Ranitidine oxime2 0.21
Ranitidine amino oti3 0.45
Ranitidine diamine4 0.57
Ranitidine S-oxide5 0.64
Ranitidine N-oxide6 0.72
Ranitidine eka nitroacetamide7 0.84
Ranitidine formaldehyde adduct8 1.36
Ranitidine bis-compound9 1.75
1 N-Methyl-2-nitroacetamide.
2 3- (Methylamino) -5,6-dihydro-2H-1,4-thiazin-2-ọkan oxime.
3 {5-[(Dimethylamino)methyl]furan-2-yl}methanol.
4 5-{[(2-Aminoethyl)thio]methyl}-N, N-dimethyl-2-furanmethanamine (ranitidine ti o ni ibatan agbo A).
5 N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N¢-methyl-2-nitro-1,1-ethenediamine (ranitidine ti o ni ibatan agbo 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 ti o ni ibatan agbo B).
Ṣe iwọn awọn idahun fun awọn oke pataki, ki o si ṣe iṣiro ipin ogorun aimọ kọọkan ninu apakan ti Ranitidine Hydrochloride ti o mu nipasẹ agbekalẹ:
100CV/W(ri / rS)
ninu eyiti C jẹ ifọkansi, ni mg fun milimita, ti ranitidine hydrochloride ninu ojutu Standard;V jẹ iwọn didun, ni milimita, ti ojutu Idanwo;W jẹ iwuwo, ni mg, ti Ranitidine Hydrochloride ti a mu lati ṣeto ojutu Idanwo;ri jẹ idahun ti o ga julọ fun aimọ kọọkan ti a gba lati inu ojutu Idanwo;ati rS ni idahun tenitidine tente oke ti a gba lati inu ojutu Standard: ko ju 0.3% ti ranitidine bis-compound ti wa ni ri, ko ju 0.1% ti eyikeyi aimọkan miiran ti a rii, ati pe ko ju 0.5% ti awọn idoti lapapọ ni a rii. .Ipele ijabọ fun awọn aimọ jẹ 0.05%.
Ayẹwo-
Ifipamọ Phosphate-Ibi isunmọ 1900 milimita ti omi ninu ọpọn iwọn didun 2.0-L, ṣafikun 6.8 milimita ti phosphoric acid ni deede, ati dapọ.Fi deede kun 8.6 milimita ti 50% iṣuu soda hydroxide ojutu, ati dilute pẹlu omi si iwọn didun.Ti o ba jẹ dandan, ṣatunṣe pẹlu 50% iṣuu soda hydroxide ojutu tabi phosphoric acid si pH ti 7.1, ati àlẹmọ.
Solusan A-Mura adalu Phosphate saarin ati acetonitrile (98:2).
Solusan B-Mura adalu Phosphate saarin ati acetonitrile (78:22).
Alakoso Alagbeka-Lo awọn akojọpọ oniyipada ti Solusan A ati Solusan B gẹgẹbi a ti ṣe itọsọna fun eto Chromatographic.Ṣe awọn atunṣe ti o ba jẹ dandan (wo Ibaramu Eto labẹ Chromatography 621).
Diluent-Lo Solusan A.
Igbaradi boṣewa-Tu opoiye iwuwo deede ti USP Ranitidine Hydrochloride RS ni Diluent lati gba ojutu kan ti o ni ifọkansi ti a mọ ti bii 0.125 mg ti ranitidine hydrochloride fun milimita.
Ojutu ipinnu-Gbigbe lọ si iwọn 1.3 miligiramu ti USP Ranitidine Resolution Mixture RS si ọpọn iwọn didun 10-mL, ki o tu sinu ati dilute pẹlu Diluent si iwọn didun.[akọsilẹ-USP Ranitidine Resolution Mixture RS ni ranitidine hydrochloride ati awọn aimọ mẹrin ti o ni ibatan: ranitidine amino alcohol hemifumarate, ranitidine diamine hemifumarate, ranitidine N-oxide, ati ranitidine complex nitroacetamide.]
Igbaradi Assay-Gbigbe lọ si nkan bii 25 miligiramu ti Ranitidine Hydrochloride, ni iwọn deede, si ọpọn iwọn didun 200-mL kan.Tu sinu ati dilute pẹlu Diluent si iwọn didun, ati dapọ.
Eto Chromatographic (wo Chromatography <621>) -Kromatograph olomi ti ni ipese pẹlu aṣawari 230-nm ati iwe 4.6-mm × 10-cm ti o ni 3.5-µm iṣakojọpọ L1 ti o jẹ iduroṣinṣin lati pH 1 si 12. Iwọn sisan jẹ nipa 1,5 milimita fun iṣẹju kan.Awọn iwọn otutu ọwọn ti wa ni itọju ni 35. Awọn chromatograph ti wa ni siseto gẹgẹbi atẹle.
Akoko (iṣẹju) Solusan A (%) Solusan B (%) Elution
0-10 100®0 0®100 itọka laini
10-15 0 100 isocratic
15-16 0®100 100®0 itọka laini
16-20 100 0 re-equilibrationChromatograph the Resolution ojutu, ki o si da awọn tente oke lilo awọn tabili ti impurities ati ibaje awọn ọja (ri loke): ipinnu, R, laarin awọn oke fun ranitidine N-oxide ati ranitidine eka nitroacetamide ko kere ju 1.5.Chromatograph igbaradi Standard, ati ṣe igbasilẹ awọn idahun ti o ga julọ bi a ti ṣe itọsọna fun Ilana: iyapa boṣewa ojulumo fun awọn abẹrẹ atunda ko ju 1.0%.
Ilana-Lọtọ ara awọn ipele dogba (bii 10 µL) ti igbaradi Standard ati igbaradi Assay sinu chromatograph, ṣe igbasilẹ awọn chromatograms, ati wiwọn awọn agbegbe fun awọn oke giga.Ṣe iṣiro ipin ogorun C13H22N4O3S·HCl ni apakan ti Ranitidine Hydrochloride ti o mu nipasẹ agbekalẹ:
100(CS/CU)(rU/rS)
ninu eyiti CS ati CU jẹ awọn ifọkansi, ni mg fun mL, ti ranitidine hydrochloride ni igbaradi Standard ati igbaradi Assay, lẹsẹsẹ;ati rU ati rS jẹ awọn idahun ti o ga julọ ti a gba lati igbaradi Assay ati igbaradi Standard, lẹsẹsẹ.