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 wuxuu ka kooban yahay wax aan ka yarayn 97.5 boqolkiiba oo aan ka badnayn 102.0 boqolkiiba C13H22N4O3S·HCl, oo lagu xisaabiyo sal qallalan.
Baakadaha iyo kaydinta-Ku xafid weelasha cidhiidhiga ah, iftiinka u adkaysta.
Heerarka Tixraaca USP <11>-
USP Ranitidine Hydrochloride RS
Isku darka Xallinta USP Ranitidine RS
Waa isku dhafka ranitidine hydrochloride iyo afar wasakh ah oo la xidhiidha: ranitidine-N-oxide, ranitidine complex nitroacetamide, ranitidine diamine hemifumarate, iyo ranitidine amino khamriga hemifumarate.
Ranitidine-N-oxide: N, N-dimethyl[5-[[2-[[1-(methylamino) -2-nitroethenyl] amino] ethyl] sulphanyl] methyl]furan-2-yl] methanamin N-oxide.
Nitroacetamide kakan Ranitidine: N-[2-[[[5-[(dimethylamino)methyl]furan-2-yl]methyl] sulphanyl] ethyl] -2-nitroacetamide.
Ranitidine diamine hemifumarate (ka kooban A): 5-[[(2-aminoethyl) thio] methyl]-N, N-dimethyl-2-furanmethanamine, hemifumarate cusbo.
Ranitidine amino khamriga hemifumarate: [5-[(dimethylamino)methyl]furan-2-yl] methanol.
Aqoonsiga -
J: Nuugista Infrared <197M>.
B: Nuugista Ultraviolet <197U>-
Xalka: 10 µg halkii ml.
Dhexdhexaad: biyo.
Nuugista 229 nm iyo 315 nm, oo lagu xisaabiyo saldhigga la qalajiyey, kama duwana in ka badan 3.0%.
C: Xalka ka mid ah wuxuu buuxinayaa shuruudaha baaritaannada Chloride <191>.
pH <791>: inta u dhaxaysa 4.5 iyo 6.0, ee xal (1 in 100).
Luminta qalajinta <731>-Ku qalaji faakuum 60 ilaa 3 saacadood: waxay luminaysaa wax aan ka badnayn 0.75% miisaankeeda.
Hadhaaga dabka <281>: aan ka badnayn 0.1%.
Daahirnimada Chromatographic-
Diluent, Marxaladda Wareegta, Xalka Xallinta, iyo Nidaamka Chromatographic-ku soco sida lagu faray Imtixaanka.
Xalka caadiga ah-U diyaari sida lagu faray diyaarinta Heerka ee Assay.
Tijaabi xalka-U diyaari sida lagu faray diyaarinta Assay ee Assay.
Habka-Si gooni ah u duri mugga siman (qiyaastii 10 µL) ee xalka Heerka iyo xalka Tijaabada chromatograph-yada, duub chromatogram-yada, oo cadee meesha ugu sarreysa ee ranitidine iyo meelaha ugu sarreeya ee wasakhda iyo nabaad-guurka ee ku taxan shaxda hoose.
Magaca Wakhtiga Haynta Qaraabo
Ranitidine fudud nitroacetamide1 0.14
Ranitidine oxime2 0.21
Ranitidine amino khamriga3 0.45
Ranitidine diamine4 0.57
Ranitidine S-oxide5 0.64
Ranitidine N-oxide6 0.72
Nitroacetamide kakan Ranitidine7 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-hal oxime.
3 {5-[(Dimethylamino)methyl]furan-2-yl}methanol.
4 5-{[(2-Aminoethyl) thio] methyl}-N, N-dimethyl-2-furanmethanamine (ranitidine la xiriira isku dhafka A).
5 N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl] ethyl}-N¢-methyl-2-nitro-1,1-ethenediamine (ranitidine xiriir la leh C).
6 N,N-Dimethyl(5-{[(2-{[1-(methylamino))-2-nitroethenyl]amino}ethyl)
sulphanyl]methyl}furan-2-yl) methanamin 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 laxiriira walaxda B).
Cabir jawaabaha meelaha ugu sarreeya, oo xisaabi boqolkiiba wasakh kasta ee qaybta Ranitidine Hydrochloride ee ay qaadatay qaacidada:
100CV/W (ri / rS)
taas oo C ay tahay xoojinta, mg per mL, ee ranitidine hydrochloride ee xalalka Standard;V waa mugga, mL, ee xalka Tijaabada;W waa miisaanka, mg, ee Ranitidine Hydrochloride ee la qaaday si loogu diyaariyo xalka tijaabada;ri waa jawaabta ugu sarreysa ee wasakh kasta oo laga helo xalka Imtixaanka;iyo rS waa jawaabta ugu sarreysa ranitidine ee laga helay xalalka caadiga ah: in aan ka badnayn 0.3% ee ranitidine bis-compound ayaa la helaa, in aan ka badnayn 0.1% wax kasta oo wasakh ah oo kale ayaa la helaa, oo aan ka badnayn 0.5% wadarta wasakhda la helay .Heerka warbixinta ee wasakhda waa 0.05%.
Imtixaan-
Buffer Fosfate-Ku rid qiyaastii 1900 ml oo biyo ah galaas mug leh oo 2.0-L ah, si sax ah ugu dar 6.8 mL oo ah aashitada fosfooraska, oo isku qas.Si sax ah ugu dar 8.6 mL oo ah 50% sodium hydroxide xal, oo ku mil biyo mugga.Haddii loo baahdo, ku hagaaji 50% xal sodium hydroxide ama phosphoric acid pH of 7.1, oo shaandhayso.
Xalka A- Diyaari isku dhafka Fosfate-ka iyo acetonitrile (98:2).
Xalka B- Diyaari isku dhafka Fosfate-ka iyo acetonitrile (78:22).
Marxaladda mobilada-Isticmaal isku dhafka kala duwan ee Xalka A iyo Xalka B sida lagu faray nidaamka Chromatographic.Samee hagaajin haddii loo baahdo (eeg Habboonaanta Nidaamka ee hoos timaada Chromatography 621).
Isticmaalka-Isticmaalka Xalka A.
Diyaargarowga caadiga ah-Mila tirada saxda ah ee USP Ranitidine Hydrochloride RS ee Diluent si aad u hesho xal la og yahay oo ku saabsan 0.125 mg ee ranitidine hydrochloride halkii ml.
Xalka xallinta-Ku wareeji qiyaastii 1.3 mg ee USP Ranitidine Resolution Mixture RS una wareeji 10-mL weel mug leh, oo ku mil oo ku milmi Diluent ilaa mug.[xusuus-USP Ranitidine Xallinta Isku-dhafka RS waxa ku jira ranitidine hydrochloride iyo afar wasakh ah oo la xidhiidha: ranitidine amino alcohol hemifumarate, ranitidine diamine hemifumarate, ranitidine N-oxide, iyo ranitidine complex nitroacetamide.]
Diyaarinta Assay-Ku wareeji qiyaastii 25 mg oo Ranitidine Hydrochloride ah, oo si sax ah loo miisaamay, una wareejiso 200-mL weel mug leh.Ku milmi oo ku milmi Diluent ilaa mugga, oo qas.
Nadaamka Chromatographic (eeg Chromatography <621>)-Kromaatograph-ka dareeraha ah waxa uu ku qalabaysan yahay 230-nm detector iyo 4.6-mm × 10-cm tiir ka kooban 3.5-µm xirmo L1 oo deggan pH 1 ilaa 12. Heerka socodka waa qiyaastii 1.5 mL daqiiqadii.Heerkulka tiirka waxaa lagu hayaa 35. chromatograph-ka waxaa loo habeeyey sida soo socota.
Waqtiga (daqiiqado) Xalka A (%) Xalka B (%) Elution
0-10 100®0 0®100 jaanis toosan
10-15 0 100 isocratic
15-16 0®100 100®0 jaanis toosan
16-20 100 0 dib-u-dheellitirka Chromatograph Xalka Xallinta, oo aqoonso meelaha ugu sarreeya iyadoo la adeegsanayo shaxda wasakhda iyo wax-soo-saarka (korka laga helay): xallinta, R, inta u dhaxaysa meelaha ugu sarreeya ee ranitidine N-oxide iyo ranitidine complex nitroacetamide kama yara 1.5.Chromatograph ee heerka diyaarinta, oo diwaangeli jawaabaha ugu sarreeya sida lagu faray Habraaca: jaangooyada heerka qaraabo ee cirbadaha soo noqnoqda kama badna 1.0%.
Habka-Si gooni ah u duri mugga siman (qiyaastii 10 µL) ee diyaarinta Heerka iyo diyaarinta Assay chromatograph-ka, duub chromatogram-yada, oo cabbir aagagga meelaha ugu sarreeya.Xisaabi boqolkiiba C13H22N4O3S·HCl ee qaybta Ranitidine Hydrochloride ee ay qaadatay qaacidada:
100 (CS / CU) (rU / rS)
kuwaas oo CS iyo CU ay yihiin uruurinta, mg per mL, ee ranitidine hydrochloride ee diyaarinta Standard iyo diyaarinta Assay, siday u kala horreeyaan;iyo rU iyo rS waa jawaabaha ugu sarreeya ee laga helay diyaarinta Assay iyo heerka diyaarinta, siday u kala horreeyaan.