I-Ondansetron Hydrochloride Dihydrate CAS 103639-04-9 Assay 98.0 ~ 102.0%

Inkcazelo emfutshane:

Igama leMichiza: Ondansetron Hydrochloride Dihydrate

CAS: 103639-04-9

Uvavanyo: 98.0 ~ 102.0% (Ibalwe kwisiseko se-anhydrous)

Imbonakalo: Umgubo weCrystalline oMhlophe okanye oMhlophe

I-Serotonin ethile (i-5-HT3) ye-Receptor Antagonist.I-Antiemetic

Qhagamshelana: UGqr. Alvin Huang

Iselula/Wechat/WhatsApp: +86-15026746401

E-Mail: alvin@ruifuchem.com

Thumela i-imeyile kuthi

Iinkcukacha zeMveliso

Iimveliso ezinxulumeneyo

Iithegi zeMveliso

Inkcazo:

I-Shanghai Ruifu Chemical ngumenzi ohamba phambili we-Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) enomgangatho ophezulu.I-Ruifu inokubonelela ngenkonzo yehlabathi jikelele, ixabiso elikhuphisanayo, inkonzo egqwesileyo, amancinci kunye nezixa ezininzi ezikhoyo.Thenga i-Ondansetron Hydrochloride Dihydrate,Please contact: alvin@ruifuchem.com

AbaPhathi abanxulumeneyo:

AbaPhakathi abanxulumeneyo be-Ondansetron Hydrochloride Dihydrate

1,3-Cyclohexanedione	I-CAS 504-02-9
1,2,3,9-Tetrahydro-9-Methyl-4H-Carbazole-4-enye	I-CAS 27387-31-1
Ondansetron Hydrochloride Dihydrate	I-CAS 103639-04-9

Iipropati zeMichiza:

Igama leMchiza	Ondansetron Hydrochloride Dihydrate
Izithethantonye	I-Ondansetron HCl Dihydrate;1,2,3,9-Tetrahydro-9-Methyl-3-[(2-Methyl-1H-imidazol-1-yl) methyl]-4H-Carbazol-4-one Hydrochloride Dihydrate;Emeset;GR 38032 Hydrochloride Dihydrate;SN 307 Hydrochloride Dihydrate;GR 3832 HCl 2H2O;SN-37 HCl 2H2O;NSC665799 HCl 2H2O
Ubume beStokhwe	Kwisitokhwe, isikali soRhwebo
Inombolo yeCAS	103639-04-9 (Dihydrate)
Enxulumene CAS RN	99614-02-5 (Isiseko) & 99614-01-4 (Anhydrous)
Ifomula yeemolekyuli	C18H19N3O·HCl·2H2O
Ubunzima beMolekyuli	365.86 g/mol
Indawo yokunyibilika	176.0 ukuya 180.0℃
Inovakalelo	Ubushushu Bubuthathaka
Ukunyibilika kwamanzi	Inyibilika emanzini (>5 mg/ml)
Ugcino Temp.	Indawo epholileyo neyomileyo (2~8℃)
I-COA kunye ne-MSDS	Iyafumaneka
Uphawu	Ruifu Chemical

Iinkcukacha:

Izinto	ImiGangatho yokuHlola	Iziphumo
Imbonakalo	Mhlophe ukuya kuMhlophe oMhlophe wePowder	Iyahambelana
Ukuchongwa
1. UV	Ubukhulu 209, 248, 267, 310nm	Ufanelekile
2. I-IR spectrum	Iyahambelana neSakhiwo	Ufanelekile
3. Ucalucalulo lweChloride	Phambili Ukusabela	Ufanelekile
Amanzi nguKarl Fischer	9.0~10.5%	9.7%
Intsalela kwi-Ignition	≤0.10%	0.03%
Iintsimbi ezinzima (Pb)	≤10ppm	<10ppm
I-Ondansetron eNxulumene nayo iCompound C	≤0.20%	0.09%
Ikhompawundi eNxulumene ne-Ondansetron D	≤0.10%	0.04%
Imidazole	≤0.20%	0.02%
2-Methylimidazole	≤0.20%	0.02%
I-Ondansetron eNxulumene nayo iCompound A	≤0.20%	0.05%
Okunye Ukungacoceki Okukodwa okungaziwayo	≤0.10%	0.07%
Ukungcola ngokupheleleyo	≤0.50%	0.29%
Intsalela yokunyibilika
I-Ethanol	≤5000ppm	240ppm
Isivavanyi	98.0 ~ 102.0% (Ibalwe kwisiseko se-anhydrous)	99.81%
Ukuqukumbela	Imveliso ivavanyiwe kwaye iyahambelana neenkcukacha

Ukupakishwa/uGcino/Ukuhambisa ngenqanawe:

Umqulu:Ibhotile, ingxowa yefoyile yeAluminiyam, 25kg/Igubu lekhadibhodi, okanye ngokwemfuno yomthengi.
Imeko yoGcino:Gcina kwisitya esivaliweyo.Gcina kwindawo epholileyo, eyomileyo (2~8℃) kunye nendawo yokugcina impahla engenamoya kude nezinto ezingahambelaniyo.Khusela ukukhanya kunye nokufuma.
Ukuhambisa ngenqanawe:Zisa kwihlabathi liphela ngomoya, ngeFedEx / DHL Express.Ukubonelela ngokukhawuleza nangokuthembekileyo.

Izinto eziluncedo:

Umthamo owaneleyo: Izixhobo ezaneleyo kunye namagcisa

Inkonzo yobuNgcali: Inkonzo enye yokuyeka ukuthenga

Ipakethe ye-OEM: Iphakheji yesiko kunye neleyibhile ekhoyo

Ukuhanjiswa ngokukhawuleza: Ukuba ngaphakathi kwesitokhwe, ukuhanjiswa kweentsuku ezintathu kuqinisekisiwe

Ubonelelo oluzinzileyo: Gcina isitokhwe esifanelekileyo

Inkxaso yobuGcisa: Isisombululo seTekhnoloji siyafumaneka

Inkonzo yesiNtu yoHlanganiso: Isuka kwiigram ukuya kwiikhilos

Umgangatho ophezulu: Kusekwe inkqubo epheleleyo yokuqinisekisa umgangatho

FAQ:

Ukuthenga njani?Nceda uqhagamshelaneDr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com

Amava Eminyaka Eli-15?Sineminyaka engaphezu kwe-15 yamava ekwenziweni nasekuthumeleni kumazwe angaphandle uluhlu olubanzi oluphezulu lwamayeza aphakathi okanye amachiza alungileyo.

Iimarike eziphambili?Thengisa kwimarike yasekhaya, eMntla Melika, eYurophu, eIndiya, eKorea, eJapan, eOstreliya, njl.

Iingenelo?Umgangatho ophezulu, ixabiso elifikelelekayo, iinkonzo zengcali kunye nenkxaso yobugcisa, ukuhanjiswa ngokukhawuleza.

UmgangathoIsiqinisekiso?Inkqubo yokulawula umgangatho ongqongqo.Izixhobo zobuchwephesha zokuhlalutya ziquka i-NMR, LC-MS, GC, HPLC, ICP-MS, UV, IR, OR, KF, ROI, LOD, MP, Clarity, Solubility, Microbial limit test, njl.

Iisampulu?Uninzi lweemveliso zibonelela ngeesampulu zasimahla zokuvavanya umgangatho, iindleko zokuthumela kufuneka zihlawulwe ngabathengi.

Factory Audit?Uphicotho-zincwadi lwasefektri wamkelekile.Nceda wenze idinga kwangaphambili.

MOQ?Akukho MOQ.Umyalelo omncinci wamkelekile.

Ixesha lokuzisa? Ukuba ngaphakathi kwesitokhwe, ukuhanjiswa kweentsuku ezintathu kuqinisekisiwe.

Ezothutho?Nge-Express (FedEx, DHL), ngoMoya, ngoLwandle.

Amaxwebhu?Emva kwenkonzo yokuthengisa: I-COA, i-MOA, i-ROS, i-MSDS, njl.

Udibaniso lweSiko?Inokubonelela ngeenkonzo zesiko lokudibanisa ukuze zilungele iimfuno zakho zophando.

Immimiselo yokuhlawula?I-invoyisi yeProforma iya kuthunyelwa kuqala emva kokuqinisekiswa kwe-odolo, efakwe kwiinkcukacha zethu zebhanki.Intlawulo nge-T / T (i-Telex Transfer), i-PayPal, i-Western Union, njl.

103639-04-9 - Umngcipheko kunye noKhuseleko:

Iikhowudi zoMngcipheko
I-R25 - Inetyhefu xa iginyiwe
R36/37/38 - Ukucaphukisa emehlweni, inkqubo yokuphefumla kunye nolusu.
Inkcazelo yoKhuseleko
S45 - Kwimeko yengozi okanye ukuba uziva ungaphilanga, funa ingcebiso kagqirha ngokukhawuleza (bonisa ileyibhile nanini na kunokwenzeka.)
I-S37/39 - Nxiba iiglavu ezifanelekileyo kunye nokukhusela amehlo / ubuso
S26 - Xa udibana namehlo, hlambulula ngokukhawuleza ngamanzi amaninzi kwaye ufune iingcebiso zonyango.
Ii-ID ze-UN UN 2811 6.1/PG 3
WGK eJamani 3
RTECS FE6375500
Ikhowudi yeHS 29339900
Udidi lweeNgozi 6.1(a)
Ukupakisha Iqela II

103639-04-9 - Isicelo:

I-Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) i-serotonin ethile (5-HT3) i-receptor antagonist.I-Antiemetic.I-Ondansetron Hydrochloride Dihydrate isetyenziselwa ukukhusela isicaphucaphu kunye nokuhlanza okunokuthi kubangelwa utyando, i-chemotherapy yomhlaza, okanye unyango lwe-radiation.I-5-HT3 ye-receptor antagonists e-Ondansetron ziziyobisi eziphambili ezisetyenziselwa ukunyanga nokukhusela i-chemotherapy-induced nausea kunye nokuhlanza kunye ne-radiotherapy-induced-induced nausea kunye nokuhlanza, ngokuthintela izenzo zeekhemikhali emzimbeni.Ukusebenza kakuhle kune-metoclopramide ngelixa i-sedating encinci kune-cyclizine okanye i-droperidol.Nangona kunjalo, ayinayo impembelelo encinci ekugabheni okubangelwa sisifo sokuhamba.Inokunikelwa ngomlomo, ngokutofa kwisihlunu okanye kumthambo.

I-Ondansetron kunye ne-Granisetron, i-Dolasetron zintathu eziqhelekileyo ezisetyenziswa kwikliniki ye-antiemetics, i-ondansetron i-serotonin esebenzayo (i-5-HT3) i-receptor blocker eguqulwayo kwaye ikhethe, i-α1, i-α2, i-β1, i-β2-adrenergic receptors kunye ne-histamine H1, i-H2 receptors, inesiphumo esincinci, kwii-H receptors, i-central and peripheral dopaminergic receptors, ayinayo isiphumo esichasayo, inokucinezela ichemotherapy kunye nesicaphucaphu kunye nokugabha.Xa kuthelekiswa ne-metoclopramide, impembelelo yayo ye-antiemetic yomelele kwaye ayinayo i-extrapyramidal reactions.Ukuhlanza okubangelwa yi-cisplatin, i-cyclophosphamide, i-doxorubicin, njl. inokuvelisa i-antiemetic ekhawulezayo kunye nenamandla.Ayifanelekanga kuphela kunyango lwesicaphucaphu kunye nokugabha okubangelwa yi-cytotoxic chemotherapy kunye nonyango lwemitha, kodwa kunye nokuthintela kunye nonyango lwesicaphucaphu kunye nokugabha okubangelwa lutyando.I-Ondansetron isebenza njengendawo yokuhamba phakathi kwe-nerve ye-visceral afferent esebenzayo kwi-gastrointestinal tract kunye neziko lokuhlanza ngaphakathi kwentambo yomgogodla, ekhokelela kwi-diaphragm kunye neentshukumo zesisu zesisu.I-Chemotherapy kunye nonyango lwe-radiation lunokubangela ukukhululwa kwe-intestinal 5-HT kwaye kubangele i-vagus nerve stimulation yi-5-HT3 receptor, ebangela ukuhlanza i-reflex.Le mveliso ithintela ukuba kwenzeke le reflex, kwangaxeshanye ivalela ukugabha okubangelwa sisenzo esiphakathi.Indlela malunga nesicaphucaphu kunye nokuhlanza emva kokuhlinzwa ayaziwa.I-Ondansetron idityaniswe ne-dexamethasonecan inokuphucula impembelelo yokuchasana nokuchachamba.

103639-04-9 - Iimpembelelo ezisecaleni:

Oku kubangela ukukhutshwa kwe-vagal afferent, kubangela ukugabha.Ekubopheni i-5-HT3 receptors, i-ondansetron ibhloka i-serotonin stimulation, ngoko ke ukuhlanza, emva kwe-emetogenic stimuli efana ne-cisplatin.Intloko ebuhlungu yeyona nto ixhaphakileyo isiphumo esibi sala mayeza.

103639-04-9 - Iprofayile yoKhuseleko:

Ityhefu ngomzila womithanjana.Iimpembelelo zenkqubo yomntu ngomzila womthambo: ijaundice.Xa ishushu ukuze ibole ikhupha umphunga oyityhefu weNOx.

103639-04-9 - Amachiza ezilwanyana kunye noNyango:

Isetyenziswa njenge-antiemetic xa i-antiemetics eqhelekileyo ingasebenzi, njengaxa uhambisa i-cisplatin okanye ezinye izizathu zokugabha okungapheliyo.Ukusetyenziswa kwe-ondansetron kwiikati kuyaphikisana kwaye ezinye zithi akufanele zisetyenziswe kule ntlobo.

Ukudibana kweziyobisi Ukudibana okunokuba yingozi namanye amachiza.

103639-04-9 - USP35 Umgangatho:

I-Ondansetron Hydrochloride iqulethe ngaphantsi kweepesenti ze-98.0 kwaye ingabi ngaphezu kwe-102.0 ipesenti ye-C18H19N3O · HCl, ibalwa kwisiseko se-anhydrous.

Ukupakishwa kunye nokugcinwa-Londoloza kwimigqomo eqinile, ekwazi ukumelana nokukhanya.Gcina kwi-25

, uhambo oluvunyelwe phakathi kwe-15

kunye ne30

Imigangatho yezalathiso ye-USP <11>-

USP Ondansetron Hydrochloride RS

USP Ondansetron Related Compound A RS

3 [(Dimethylamino) methyl] -1,2,3,9-tetrahydro-9-methyl-4H-carbazol-4-enye.

USP Ondansetron Resolution Mixture RS

I-Ondansetron hydrochloride ene-0.4% w / w yazo zombini i-ondansetron enxulumene nekhompawundi A kunye ne-6,6¢-methylene bis-[(1,2,3,9-tetrahydro-9-methyl-3- [(2-methyl-1H--) imidazol-1-yl)-methyl]-4H-carbazol-4-enye)]

USP Ondansetron Related Compound C RS
1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-enye.

USP Ondansetron Related Compound D RS
1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-enye.

Isazisi-

A: I-Infrared Absorption <197M>.

B: Dissolve 20 mg kwi-2 mL yamanzi, yongeza i-1 mL ye-2 M nitric acid, kunye ne-filtrate: i-filtrate iphendula uvavanyo lwe-Chloride <191>.

Amanzi, Indlela Ia <921>: phakathi kwe-9.0% kunye ne-10.5%.

Intsalela ekutshisweni <281>: hayi ngaphezulu kwe-0.1%.

Umda we-ondansetron enxulumene nekhompawundi D-

Isigaba seselula- Lungisa umxube ohluziweyo kunye ne-degassed ye-0.02 M monobasic potassium phosphate (eyalungiswa ngaphambili nge-1 M sodium hydroxide ukuya kwi-pH ye-5.4) kunye ne-acetonitrile (80:20).Yenza uhlengahlengiso xa kukho imfuneko (jonga ukufaneleka kweNkqubo phantsi kweChromatography <621>).

Isisombululo esisemgangathweni-Dibanisa isixa esinomlinganiso ngokuchanekileyo we-USP Ondansetron eNxulumeneyo neCompound D RS kwisigaba seMobile, kwaye unciphise ngokobungakanani, kwaye ngokwenyathelo xa kukho imfuneko, ngesigaba seMobile ukufumana isisombululo esinoxinzelelo olwaziwayo malunga ne-0.4 µg ngemL.

Isisombululo sokufaneleka kwenkqubo-Dibanisa imiyinge efanelekileyo ye-USP Ondansetron eNxulumeneyo neCompound D RS kunye ne-USP Ondansetron eNxulumeneyo neCompound C RS kwisigaba seMobile, kwaye uhlambulule ngokobungakanani, kwaye ngokwenyathelo xa kukho imfuneko, kunye nesigaba seMobile ukufumana isisombululo esinoxinzelelo olumalunga ne-0.6 µg ngemL nganye kunye ne-1 µg ngemL, ngokulandelelanayo.

Isisombululo sovavanyo-Ukudlulisa malunga ne-50 mg ye-Ondansetron Hydrochloride, ilinganiswe ngokuchanekileyo, kwi-flask ye-volumetric ye-100-mL, i-diluble in and dilute with Mobile phase to volume, and mix.

Inkqubo yeChromatographic (jonga iChromatography <621>) -I-chromatograph yolwelo ixhotyiswe nge-328-nm detector kunye nekholamu ye-4.6-mm × 25-cm equlethe ukupakisha i-L10.Izinga lokuhamba malunga ne-1.5 mL ngomzuzu.I-Chromatograph isisombululo sokufaneleka kweSistim, kwaye urekhode iimpendulo eziphezulu njengoko ziqondiswe kwiNkqubo: amaxesha okugcinwa okuhambelanayo malunga ne-0.8 ye-ondansetron ehambelana ne-compound C kunye ne-1.0 ye-ondansetron ehambelana ne-compound D;kunye nesisombululo, R, phakathi kwe-ondansetron enxulumene nekhompawundi C kunye ne-ondansetron enxulumene nekhompawundi D ayikho ngaphantsi kwe-1.5.I-Chromatograph isisombululo soMgangatho, kwaye urekhode iimpendulo eziphakamileyo njengoko ziqondiswe kwiNkqubo: ukusebenza kakuhle kwekholomu kunqunywe kwincopho ye-analyte ayikho ngaphantsi kwe-400 ye-theoretical plates;kunye nokutenxa komgangatho ozalanayo wokuphindaphinda iinaliti akukho ngaphezu kwe-2.0%.

Inkqubo- Ngokwahlukileyo tofa imithamo elinganayo (malunga nama-20 µL) yesisombululo soMgangatho kunye nesisombululo soVavanyo kwichromatograph, urekhode iichromatogram, kwaye ulinganise iimpendulo zeencopho ezinkulu.Bala ipesenti ye-ondansetron enxulumene nekhompawundi D kwinxalenye ye-Ondansetron Hydrochloride ethathwe ngefomula:

10,000(C/W)(rU / rS)

apho i-C igxininise, kwi-mg nge-mL, ye-USP Ondansetron eNxulumene neCompound D RS kwisisombululo soMgangatho;W ubunzima, kwi-mg, ye-Ondansetron Hydrochloride ethathwe ukulungiselela isisombululo soVavanyo;kunye ne-rU kunye ne-rS ziindawo eziphakamileyo ezifunyenwe kwisisombululo soVavanyo kunye nesisombululo soMgangatho, ngokulandelanayo: akukho ngaphezu kwe-0.10% efunyenweyo.

Ukucoceka kweChromatographic-

indlela i-

Isisombululo sesisombululo-Dibanisa ubuninzi be-USP Ondansetron Resolution Mixture RS kwi-methanol, kwaye uhlambulule ngokomlinganiselo, kunye nesinyathelo xa kuyimfuneko, kunye ne-methanol ukufumana isisombululo esinoxinzelelo olwaziwayo lwe-12.5 mg nge-mL.

Izisombululo eziqhelekileyo-Dibanisa ubungakanani obulinganiswe ngokuchanekileyo be-USP Ondansetron Hydrochloride RS kwi-methanol, kwaye udibanise ukufumana isisombululo esinoxinzelelo olwaziwayo malunga ne-0.25 mg nge-mL.Ngobungakanani bokunciphisa esi sisombululo nge-methanol ukufumana izisombululo eziMgangatho, ezichazwe ngezantsi ngeleta, ezineziqulatho ezilandelayo:

Isisombululo esisemgangathweni	Ukunciphisa	Ugxininiso (µg RS ngemL)	Ipesenti (%, xa kuthelekiswa nomzekelo wovavanyo)
A	(1 kwisi-5)	50	0.4
B	(1 kwi-10)	25	0.2
C	(1 kuma-20)	12.5	0.1

Isisombululo sovavanyo-Dibanisa isixa esilinganiswe ngokuchanekileyo se-Ondansetron Hydrochloride kwi-methanol ukufumana isisombululo esiqulethe i-12.5 mg nge-mL.Inkqubo-Ngokwahlukileyo sebenzisa i-20 µL yesisombululo soVavanyo, i-20 µL yesisombululo soMgangatho ngamnye, kunye ne-20 µL yesisombululo kwipleyiti ecekethekileyo yechromatographic (bona iChromatography621) iqatywe nge-0.25-mm umaleko we-chromatographic umxube we-silica gel.Phuhlisa i-chromatogram kwinkqubo yokunyibilikisa equka umxube we-chloroform, i-ethyl acetate, i-methanol, kunye ne-ammonium hydroxide (90:50:40:1) de i-solvent front ihambe malunga nesithathu-esine ubude beplate.Susa ipleyiti kwigumbi, phawula i-solvent ngaphambili, kwaye uvumele i-solvent ukuba ibe ngumphunga.Jonga ipleyiti phantsi kokukhanya kwe-UV okufutshane: isisombululo esipheleleyo samacandelo amathathu eSigqibo sesisombululo sifunyenwe.Thelekisa ubunzulu bawo nawaphi na amachaphaza esibini aqatshelwe kwichromatogram yesisombululo soVavanyo kunye nalawo amabala aphambili kwichromatogram yezisombululo zoMgangatho: naliphi na ibala lesibini ukusuka kwichromatogram yesisombululo soVavanyo esinexabiso leRF elihambelana nelo lolona luphezulu lwesibini. indawo yesisombululo seSigqibo ayinkulu okanye inamandla ngaphezu kwendawo eyintloko efunyenwe kwisisombululo esisemgangathweni A (0.4%);kwaye akukho nenye indawo yesibini esuka kwichromatogram yesisombululo soVavanyo inkulu okanye iqine ngaphezu kwendawo ephambili efunyenwe kwisisombululo esiseMgangathweni B (0.2%).

indlela ii-

Isigaba esiphathwayo kunye nenkqubo yeChromatographic-Qhubeka njengoko kuyalelwe kwi-Assay.

Isisombululo esisemgangathweni-Qhuba njengoko kuqondiswe kulungiselelo oluMgangatho kwi-Assay.

Isisombululo sovavanyo-Sebenzisa ukulungiswa koVavanyo.

Inkqubo-Ngokwahlukileyo tofa imithamo elinganayo (malunga ne-10 µL) yoMgangatho wesisombululo kunye nesisombululo soVavanyo kwichromatograph, urekhode iichromatogram, kwaye ulinganise iimpendulo eziphakamileyo.Bala ipesenti yokungahlambuluki ngakunye kwinxalenye ye-Ondansetron Hydrochloride ethathwe ngefomula:

50,000(C/W)(1/F)(ri / rS)
apho i-C igxininise, kwi-mg nge-mL, ye-USP Ondansetron Hydrochloride RS kwisisombululo esiPhakathi;W ubunzima, kwi-mg, ye-Ondansetron Hydrochloride ethathwe ukulungiselela isisombululo soVavanyo;F yimpendulo ehambelanayo yokungcola njengoko kuchazwe kwitheyibhile ehamba kunye;ri yindawo encopho yokungcola ngakunye kwisisombululo soVavanyo;kunye ne-rS yindawo ephezulu ye-ondansetron efunyenwe kwisisombululo soMgangatho: ihlangabezana neemfuno ezinikwe kwitheyibhile ehamba kunye.

Igama loMdibaniso	Ixesha lokuGcina isihlobo	Isihlobo Impendulo Umba	Umda (%)
Ikhompawundi enxulumene ne-Ondansetron C	malunga ne-0.32	1.2	0.2
Ikhompawundi enxulumene ne-Ondansetron D*	malunga ne-0.34	-	0.1
Imidazole	malunga ne-0.49	0.3	0.2
2-methylimidazole	malunga ne-0.54	0.4	0.2
Ondansetron	1.0	-	-
Ikhompawundi enxulumene ne-Ondansetron A	malunga ne-1.10	0.8	0.2
Akwaziwa	-	1.0	0.1
Iyonke	-	-	0.5
* Ibalwe kuvavanyo loMda we-ondansetron enxulumene nekhompawundi D.

Isivavanyi-

Isigaba seselula-Lungisa umxube ohluziweyo kunye ne-degassed ye-0.02 M monobasic sodium phosphate (eyalungiswa ngaphambili nge-1 M sodium hydroxide kwi-pH ye-5.4) kunye ne-acetonitrile (50:50).Yenza uhlengahlengiso xa kukho imfuneko (jonga ukufaneleka kweNkqubo phantsi kweChromatography <621>).

Ulungiselelo olusemgangathweni-Nyibilikisa isixa esinomlinganiso ngokuchanekileyo we-USP Ondansetron Hydrochloride RS kwisigaba seMobile, kwaye nciphisa ngokobungakanani, kwaye ngokwenyathelo xa kukho imfuneko, ngesigaba seMobile ukufumana isisombululo esinoxinzelelo olwaziwayo malunga ne-90 µg ngemL nganye.

Isisombululo sokufaneleka kwenkqubo-Dibanisa imiyinge efanelekileyo ye-USP Ondansetron Hydrochloride RS kunye ne-USP Ondansetron eNxulumeneyo neCompound A RS kwisigaba seMobile, kwaye unciphise ngokobungakanani, kwaye ngokwenyathelo xa kukho imfuneko, ngesigaba seMobile ukufumana isisombululo esiqulathe malunga ne-90 µg ngemL kunye ne-20 µg ngemL nganye. , ngokulandelelanayo.

Ukulungiswa kwe-Assay-Ukudluliselwa malunga ne-45 mg ye-Ondansetron Hydrochloride, ilinganiswe ngokuchanekileyo, kwi-flask ye-volumetric ye-50-mL, chitha kwaye udibanise kunye nesigaba se-Mobile ukuya kwivolumu, kwaye udibanise.Umbhobho we-5.0 mL yesi sisombululo kwi-flask ye-volumetric ye-50-mL, yihlambulule ngesigaba se-Mobile ukuya kwivolumu, kwaye udibanise.

Inkqubo yeChromatographic (jonga i-Chromatography <621>) -I-chromatograph yolwelo ixhotyiswe nge-216-nm detector kunye nekholamu ye-4.6-mm × 25-cm equlethe ukupakisha i-L10.Izinga lokuhamba malunga ne-1.5 mL ngomzuzu.I-Chromatograph isisombululo sokufaneleka kweSistim, kwaye urekhode iimpendulo eziphezulu njengoko ziqondiswe kwiNkqubo: amaxesha okugcinwa okuhambelanayo malunga ne-1.0 ye-ondansetron kunye ne-1.1 ye-ondansetron ehambelana ne-compound A;kunye nesisombululo, R, phakathi kwe-ondansetron enxulumene nekhompawundi A kunye ne-ondansetron ayikho ngaphantsi kwe-1.5.I-Chromatograph Ukulungiswa koMgangatho, kwaye urekhode iimpendulo eziphakamileyo njengoko zichazwe kwiNkqubo: i-tailing factor ayikho ngaphezu kwe-2.0;kunye nokutenxa komgangatho ozalanayo wokuphindaphinda iinaliti akukho ngaphezu kwe-1.5%.

Inkqubo-Ngokwahlukileyo tofa imithamo elinganayo (malunga ne-10 µL) yolungiselelo loMgangatho kunye nolungiselelo loVavanyo kwichromatograph, urekhode iichromatograms, kwaye ulinganise iimpendulo zeencopho ezinkulu.Bala ubungakanani, kwimg, yeC18H19N3O·HCl kwinxalenye yeOndansetron Hydrochloride ethathwe ngefomula:

500C(rU / rS)
apho i-C igxininise, kwi-mg nge-mL, ye-USP Ondansetron Hydrochloride RS kulungiselelo oluMgangatho;kunye ne-rU kunye ne-rS ziindawo eziphakamileyo ezifunyenwe kulungiselelo loVavanyo kunye nolungiselelo loMgangatho, ngokulandelelanayo.

103639-04-9 - Indlela yokuvelisa:

Indlela ye-1: Emva kokusabela kwe-2-Bromoaniline kunye1,3-Cyclohexanedione, i-derivative ye-tetrahydrocarbazole yenziwe, kwaye i-compound (III) ifunyenwe ngokuphendula nge-dimethylamine kunye ne-diformaldehyde, kwaye ingenise i-dimethylaminomethyl kwi-2-position.I-3.80G ye-compound (III) yaphendulwa nge-methyl iodide ukunika i-5.72g ye-compound (IV) ngokudibanisa iqela le-amino yecala ngelixa lizisa iqela le-methyl kwindawo ye-9. 2.0g ye-compound (IV) kunye ne-2-methyl-1h. -imidazole yaphendulwa kwi-dimethylformamide ngokuvuselela kwi-95 ℃.Ukufumana i-0.60G ye-Ondansetron.

Indlela yesi-2: Ukusabela kwe-cyclohexanone kunye ne-phenylhydrazine wanika i-tetrahydrocarbazole kwi-85% yesivuno.Yinyibilikise kwi-tetrahydrofuran kunye namanzi, yongeza i-2,3 Dropwise kwi-0 ° c kwi-nitrogen, isisombululo se-5, i-6-tetrachloro-1,4-benzoquinone kwi-tetrahydrofuran yavuselelwa ukunika imveliso ye-oxidation (II) kwi-67.4% yesivuno.I-Compound (II), i-ethanol, i-hydrochloric acid, i-paraformaldehyde kunye ne-dimethylamine hydrochloride zaye zaxutywa kunye.Emva konyango, imveliso (V) yafunyanwa ngokudibanisa i-hydrochloric acid egxininisiweyo kwi-acetone kwaye ivuselela kwi-50 ℃.Kwisivuno se-71.7%.I-Compound (V) kunye ne-2-methylimidazole zaphendulwa emanzini kwi-110 ℃.Ukufumana i-compound (VI) kwi-70.9% yesivuno.ICompound (VI), methyl iodide kunye ne potassium carbonate zazanywa kwiqondo lobushushu begumbi de kwanyamalala okuqinileyo.Igalelwe emanzini, ixutywe, ihluzwe, ihlanjwe ngamanzi, kwaye iphinde ihlaziywe kwi-methanol ukuze ifumane i-ondansetron kwi-57.2% yesivuno.Uyichithe kumxube we-acetone kunye namanzi, Ngokudibanisa i-hydrochloric acid egxininisiweyo ekuphenduleni, i-ondansetron hydrochloride dihydrate yafunyanwa ngesivuno se-92.6%.

Indlela ye-3: i-compound (II), i-potassium carbonate, i-acetone kunye ne-dimethyl sulfate yaxutywa kwiqondo lokushisa.ICompound (VII) ifunyenwe ngesivuno sama-91%.I-Compound (VII) yachithwa kwi-ethanol kunye nomxube we-paraformaldehyde yabantu kunye ne-dimethylamine hydrochloride yongezwa kwiingxenye phantsi kwe-reflux.Ukuguquguquka.Emva kokunyanga, i-compound (VIII) ifunyenwe kwi-67% yesivuno.(Viii) inyibilikiswe kwi-ethanol ye-anhydrous, igesi ye-hydrogen chloride, i-hydrochloride yayo.I-hydrochloride yongezwa emanzini kwaye i-2 yongezwa kwi-50 ℃.I-Methylimidazole, i-ondansetron ye-refluxing, ivelisa i-70%.Yachithwa kwi-isopropanol, amanzi kunye ne-concentrated hydrochloric acid, kwaye ixutywe kwiqondo lokushisa lokushisa ukuze ifumane i-ondansetron hydrochloride dihydrate kwisivuno se-90.5%.