Ranitidine Hydrochloridis CAS 66357-59-3

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 hydrochloridum non minus quam 97.5 centesimas continet et non plus quam 102.0 centesimas C13H22N4O3S·HCl in fundamento exsiccato continet.
Packaging ac repono-Conserve in strictis, levibus vasis repugnantibus.
USP Reference signa <11>-
USP Ranitidine Hydrochloride RS
USP Ranitidine Resolutionum Mixturae RS
Mixtura est ex ranitidine hydrochloridis et quatuor immunditiis affinis: ranitidine-N-oxydi, ranitidine complexu nitroacetamide, ranitidine diamine hemifumarate, et ranitidine amino alcoholis hemifumarate.
Ranitidine-N-oxide: N,N-dimethyl[5-[[[2-[[1-(methylamino)-2-nitroethenyl]amino]ethyl]sulphanyl]methyl]furan-2-yl] methanamine N-oxide.
Ranitidine complexu nitroacetamide: N-[2-[[[5-[(dimethylamino)methyl]furan-2-yl]methyl]sulphanyl]ethyl]-2-nitroacetamide.
Ranitidine diamine hemifumarate (com- latum A): 5-[[(2-aminoethyl)thio]methyl]-N, N-dimethyl-2-furanmethanamine, sal hemifumaratum.
Ranitidine amino alcohol hemifumarate: [5-[(dimethylamino)methyl]furan-2-yl] methanolum.
Identification-
A: Absorptio infrared <197M>.
B: Absorptio Ultraviolet <197U>-
Solutio: 10 µg per mL.
Medium: aqua.
Absorptivitates ad 229 um et 315 um, fundamento siccato computatae, non plus quam 3.0% differunt.
C: Solutio ejus exigentiis probationum pro Chloride occurrit <191>.
inter 4.5 et 6.0, in solutione (1 in 100).
Amissio siccitate <731>- sicca in vacuo ad 60 pro 3 horis: non plus quam 0.75% sui ponderis amittit.
Residere ignitionem <281>: non plus quam 0,1%.
Chromatographic puritatis
Diluens, mobile Phase, resolutio solutionis et systematis chromatographici-Perge uti in Perge.
Standard solution-Prepara ut ordinatur ad praeparationem Latin in Assay.
Expertus solutionem-Para ut ordinatur ad praeparationem ad Assay in Assay.
De modo procedendi-Separatim inferunt paria volumina (circa 10 µL) solutionis vexilliferae et solutionis testium in chromatographum, chromatogrammata notare, et cacuminum ranitidinem recognoscere et cacumina ob immunditias et degradationes productorum in tabula infra recensita.
Nomen relativum retentionis Tempus
Ranitidine simplicis 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 complexi 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-one oxime.
3 {5-[(Dimethylamino)methyl]furan-2-yl} methanolum.
4 5-{[(2-Aminoethyl)thio]methyl}-N,N-dimethyl-2-furanmethanamine (ranitidine affinis A mixti).
5 N-{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)sulfinyl]ethyl}-N¢-methyl-2-nitro-1,1-ethenediamine (ranitidine affinis 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¢. diamine).
9 N,N¢-bis{2-[({5-[(Dimethylamino)methyl]-2-furanyl}methyl)thio]ethyl}-2-nitro-1,1-ethenediamine (ranitidine affinis mixti B).
Responsiones ad cacumina maiora metire, et recipis cuiuslibet immunditiae in portione Ranitidini hydrochloridis sumta computare per formulam:
100CV/W(ri/rS)
in qua C est concentratio in mg per mL, hydrochloridi ranitidini in solutione Vexillima;V est volumen in mL, solutionis Test.W est pondus, in mg, de Hydrochloride Ranitidine sumptum ad solutionem Testam praeparandam;ri* est apicem responsio pro qualibet immunditia ex testi solutione impetrata;et rS ranitidine apicem responsionis ex solutione Latin impetrata: non plus quam 0.3% ex ranitidine bis-com- posita, non plus quam 0.1% alterius cujusvis impuritatis reperitur, nec plus quam 0.5% totius immunditiae reperitur. .Renuntiatio campestri ad immunditias 0.05% est.
Assay-
Phosphate quiddam-Locum circa 1900 mL aquae in lagena voluminis 2.0-L, accurate adde 6.8 mL acidi phosphorici, et misce.Accurate adde solutionem hydroxidi sodii 8.6 mL%%, et cum aqua ad volumen dilutum.Si opus est, compone cum solutione hydroxidi sodium 50 vel acidum phosphoricum ad pH 7.1, et sparguntur.
Solutio A-Para mixturam quiddam phosphatis et acetonitrile (98:2).
Solutio B-Para mixturam quiddam phosphatis et acetonitrile (78:22).
Mobile phase-Usus mixtura variabilis Solutio A et Solutio B ut ad systema chromatographicum ordinatur.Fac si opus sit adaptationes (cf. Systema Suitability sub Chromatographia 621).
Diluent-usus Solutio A.
Praeparatio-dissolve accurate ponderata quantitatem USP Ranitidinis hydrochloridis RS in Diluent ad solutionem obtinendam habens notam intentionem circa 0.125 mg ranitidini hydrochloridis per mL.
Resolutio solutionis Translatio circa 1.3 mg USP Ranitidinis Resolutionis Mixturae RS ad 10-mL lagena voluminis triplicata, et dissolve et diluta ad volumen diluendum.[note-USP Ranitidine Resolutionum Mixtura RS, ranitidinem hydrochloridem continet et immunitates quatuor cognatas: ranitidinem amino alcohol hemifumarate, ranitidine diamine hemifumarate, ranitidinem N-oxydatum, et ranitidinem nitroacetamide complexum.]
Praeparatio praeparatio-Translatio circiter 25 mg Hydrochloridis Ranitidini, accurate perpensis, ad 200-mL lagena voluminis triplicata est.Dissolve, ac dilue, dilue ad volumen, ac permisce.
Systema chromatographicum (vide chromatographia <621>) - Chromatographum liquidum cum detectore 230-um instructum et 4.6-mm × 10-cm columna continens 3.5-µm stipare L1 stabilis ab pH 1 ad 12. rate fluxus est. circiter 1.5 ml per minute.Columella temperatura conservatur 35. Chromatographum hoc modo programmata est.
Solutio tempus (minuta) Solutio A (%) Solutio B (%) Elution
0-10 100®0 0®100 clivus linearis
10-15 0 100 isocratic
15-16 0®100 100®0 gradiente lineari
16-20 100 0 re-equilibrationChromatographorum solutionis resolutio, et iugis utens mensae immunditiae et degradationis productorum (inventus supra): resolutio, R, inter apices pro ranitidine N-oxide et ranitidine complexu nitroacetamide non minus est. 1.5.Chromatographum Praeparatio Standard, et refero apicem responsionum ad procedendum ordinatum: vexillum relativum declinationis ad injectiones replicatae non plus quam 1.0%.
De modo procedendi-Separatim injiciunt paria volumina (circa 10 µL) praeparationis vexilliferae et praeparationis in chromatographorum, chromatogrammata notare et areas ad cacumina maiora metire.Recipis C13H22N4O3S·HCl in portione Ranitidini hydrochloridi sumpta formula:
100(CS/CU)(rU/rS)
in quibus CS et CU sunt concentrationes, in mg per mL, ranitidine hydrochloridi in praeparatione Vexillima et Praeparatione Prima, respective;and rU and rS are the apicem responses obtained from the Assy preparation and the Latin preparation, respectively.