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 ya ƙunshi ba kasa da 97.5 bisa dari kuma bai wuce 102.0 bisa dari na C13H22N4O3S·HCl, lissafta a kan busasshen tushe.
Marufi da ajiya-Ajiye a cikin matsatsi, kwantena masu jure haske.
Matsayin Magana na USP <11>-
USP Ranitidine Hydrochloride RS
USP Ranitidine Resolution Mixture RS
Cakuda ne na ranitidine hydrochloride da ƙazanta huɗu masu alaƙa: ranitidine-N-oxide, hadaddun nitroacetamide ranitidine, ranitidine diamine hemifumarate, da ranitidine amino barasa hemifumarate.
Ranitidine-N-oxide: N, N-dimethyl[5-[[2-[[1- (methylamino) -2-nitroethenyl] amino] ethyl] sulphanyl] methyl]furan-2-yl] methanamine N-oxide.
Ranitidine hadaddun nitroacetamide: N-[2-[[[5-[(dimethylamino)methyl]furan-2-yl] methyl] sulphanyl] ethyl] -2-nitroacetamide.
Ranitidine diamine hemifumarate (abin da ke da alaƙa A): 5-[[(2-aminoethyl) thio] methyl] -N, N-dimethyl-2-furanmethanamine, gishiri hemifumarate.
Ranitidine amino barasa hemifumarate: [5-[(dimethylamino)methyl]furan-2-yl] methanol.
Ganewa-
A: Ciwon Infrared <197M>.
B: Ƙarfafawar Ultraviolet <197U>-
Magani: 10 μg kowace ml.
Matsakaici: ruwa.
Absorptivities a 229 nm da 315 nm, lasafta a kan busasshiyar tushe, ba su bambanta da fiye da 3.0%.
C: Maganin sa ya dace da buƙatun gwaje-gwaje don Chloride <191>.
pH <791>: tsakanin 4.5 da 6.0, a cikin wani bayani (1 a 100).
Asarar bushewa <731> - bushe shi a cikin injin daskarewa a 60 na tsawon sa'o'i 3: bai wuce 0.75% na nauyinsa ba.
Ragowa akan kunnawa <281>: bai wuce 0.1% ba.
Tsaftar Chromatographic-
Diluent, Lokacin Wayar hannu, Maganin Ƙaddamarwa, da Tsarin Chromatographic-Ci gaba kamar yadda aka umurce a cikin Assay.
Daidaitaccen bayani-Shirya kamar yadda aka umurce shi don Daidaitaccen shiri a cikin Assay.
Gwajin maganin-Shirya kamar yadda aka umurce shi don shirye-shiryen Assay a cikin Assay.
Tsari-Na dabam allura daidai juzu'i (kimanin 10 µL) na daidaitaccen bayani da gwajin gwajin a cikin chromatograph, yi rikodin chromatograms, da gano kololuwar ranitidine da kololuwa saboda ƙazanta da samfuran lalata da aka jera a teburin da ke ƙasa.
Sunan Lokacin Riƙewa Dangi
Ranitidine mai sauƙi nitroacetamide1 0.14
Ranitidine oxime 2 0.21
Ranitidine amino barasa 3 0.45
Ranitidine diamine 4 0.57
Ranitidine S-oxide 5 0.64
Ranitidine N-oxide 6 0.72
Ranitidine hadaddun nitroacetamide7 0.84
Ranitidine formaldehyde adduct8 1.36
Ranitidine bis-compound 1.75
1 N-Methyl-2-nitroacetamide.
2 3-(Methylamino) -5,6-dihydro-2H-1,4-thiazin-2-daya oxime.
3 {5-[(Dimethylamino)methyl]furan-2-yl} methanol.
4 5-{[(2-Aminoethyl) thio] methyl}-N, N-dimethyl-2-furanmethanamine (ranitidine related fili 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) 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- diamin).
9 N, N¢-bis{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)thio]ethyl}-2-nitro-1,1-ethenediamine (ranitidine related compound B).
Auna martani ga manyan kololuwa, kuma a ƙididdige adadin kowane ƙazanta a cikin ɓangaren Ranitidine Hydrochloride da aka ɗauka ta dabara:
100CV/W (ri / rS)
wanda C shine maida hankali, a cikin MG da ml, na ranitidine hydrochloride a cikin daidaitaccen bayani;V shine ƙarar, a cikin ml, na maganin gwajin;W shine nauyin, a cikin MG, na Ranitidine Hydrochloride da aka ɗauka don shirya maganin gwajin;ri shine mafi girman martani ga kowane kazanta da aka samu daga maganin gwajin;kuma rS shine mafi girman martanin ranitidine da aka samu daga daidaitaccen bayani: ba a sami fiye da 0.3% na ranitidine bis-compound ba, ba a sami fiye da 0.1% na kowane ƙazanta guda ɗaya ba, kuma ba fiye da 0.5% na jimlar ƙazanta ba. .Matsayin rahoto don ƙazanta shine 0.05%.
Assay-
Fosphate buffer- Wuri kamar 1900 ml na ruwa a cikin 2.0-L mai girma flask, ƙara 6.8 ml na phosphoric acid daidai, da kuma haɗuwa.Ƙara 8.6 ml na 50% sodium hydroxide bayani daidai, kuma a tsoma shi da ruwa zuwa girma.Idan ya cancanta, daidaita tare da 50% sodium hydroxide bayani ko phosphoric acid zuwa pH na 7.1, kuma tace.
Magani A-Shirya cakuɗen buffer Phosphate da acetonitrile (98:2).
Magani B-Shirya cakuɗen buffer Phosphate da acetonitrile (78:22).
Lokacin wayar hannu-Yi amfani da gauraya masu canji na Magani A da Magani B kamar yadda aka umurce su don tsarin Chromatographic.Yi gyare-gyare idan ya cancanta (duba Dacewar Tsarin ƙarƙashin Chromatography 621).
Maganin Amfani da Diluent A.
Daidaitaccen shiri-Narkar da adadin USP Ranitidine Hydrochloride RS daidai gwargwado a cikin Diluent don samun maganin sananniya na kusan 0.125 MG na ranitidine hydrochloride kowace ml.
Maganin ƙuduri-Canja wurin kusan 1.3 MG na USP Ranitidine Resolution Mixture RS zuwa 10-mL flask volumetric, da narkar da a ciki da diluent tare da Diluent zuwa girma.[bayanin kula-USP Ranitidine Resolution Mixture RS ya ƙunshi ranitidine hydrochloride da ƙazanta huɗu masu alaƙa: ranitidine amino barasa hemifumarate, ranitidine diamine hemifumarate, ranitidine N-oxide, da ranitidine hadaddun nitroacetamide.]
Shirye-shiryen Assay-Canja wurin kusan MG 25 na Ranitidine Hydrochloride, daidaitaccen auna, zuwa kwalabe mai girma na 200-ml.Narke a ciki kuma a tsoma tare da Diluent zuwa girma, da kuma haɗuwa.
Tsarin Chromatographic (duba Chromatography <621>) -Chromatograph na ruwa yana sanye da na'urar ganowa ta 230-nm da ginshiƙi na 4.6-mm × 10-cm wanda ke ɗauke da 3.5-µm packing L1 wanda ya tsayayye daga pH 1 zuwa 12. Adadin kwarara shine kimanin 1.5 ml a minti daya.Ana kiyaye zafin jiki na ginshiƙi a 35. An tsara chromatograph kamar haka.
Lokaci (minti) Magani A (%) Magani B (%) Elution
0-10 100®0 0®100 layin layi
10-15 0 100 isocratic
15-16 0®100 100®0 layin layi
16-20 100 0 sake daidaitawaChromatograph da Resolution bayani, da kuma gano kololuwa ta yin amfani da tebur na ƙazanta da ƙazanta kayayyakin (samuwa a sama): ƙuduri, R, tsakanin kololuwa ga ranitidine N-oxide da ranitidine hadaddun nitroacetamide bai kasa da 1.5.Chromatograph da Daidaitaccen shiri, da rikodin mafi girman martani kamar yadda aka ba da umarni don Tsari: madaidaitan ma'auni don maimaita alluran bai wuce 1.0% ba.
Tsari-Na dabam allura daidai juzu'i (kimanin 10 µL) na daidaitaccen shiri da shirye-shiryen Assay a cikin chromatograph, yi rikodin chromatograms, da auna wuraren don manyan kololuwa.Yi lissafin adadin C13H22N4O3S·HCl a cikin ɓangaren Ranitidine Hydrochloride wanda aka ɗauka ta dabara:
100 (CS / CU) (rU / rS)
a cikin abin da CS da CU suke da yawa, a cikin mg da ml, na ranitidine hydrochloride a cikin Shirye-shiryen Daidaitawa da Assay shirye-shiryen, bi da bi;da rU da rS sune mafi girman martanin da aka samu daga shirye-shiryen Assay da Daidaitaccen shiri, bi da bi.