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

Incazelo emfushane:

Igama Lekhemikhali: I-Ondansetron Hydrochloride Dihydrate

I-CAS: 103639-04-9

I-Assay: 98.0~102.0% (Ibalwe ngesisekelo se-anhydrous)

Ukubukeka: I-Crystalline Powder Emhlophe noma Engamhlophe

I-Specific Serotonin (5-HT3) Umphikisi Wesamukeli.I-Antiemetic

Thintana: UDkt. Alvin Huang

Iselula/Wechat/WhatsApp: +86-15026746401

E-Mail: alvin@ruifuchem.com

Thumela i-imeyili kithi

Imininingwane Yomkhiqizo

Imikhiqizo Ehlobene

Omaka bomkhiqizo

Incazelo:

I-Shanghai Ruifu Chemical ingumkhiqizi ohamba phambili we-Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) enekhwalithi ephezulu.I-Ruifu inganikeza ukulethwa komhlaba wonke, intengo encintisanayo, isevisi enhle kakhulu, amanani amancane kanye nenqwaba etholakalayo.Thenga i-Ondansetron Hydrochloride Dihydrate,Please contact: alvin@ruifuchem.com

Abalamuli Abahlobene:

Abaphakathi Abahlobene Be-Ondansetron Hydrochloride Dihydrate

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

Chemical Properties:

Igama Lekhemikhali	I-Ondansetron Hydrochloride Dihydrate
Omqondofana	I-Ondansetron HCl Dihydrate;I-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;I-SN 307 Hydrochloride Dihydrate;GR 3832 HCl 2H2O;I-SN-37 HCl 2H2O;I-NSC665799 HCl 2H2O
Isimo Sesitoko	Esitokweni, Isikali Sokuhweba
Inombolo ye-CAS	103639-04-9 (Dihydrate)
Okuhlobene CAS RN	99614-02-5 (Isisekelo) & 99614-01-4 (Amanzi)
I-Molecular Formula	C18H19N3O·HCl·2H2O
Isisindo samangqamuzana	365.86 g/mol
I-Melting Point	176.0 ukuze 180.0 ℃
Kuyazwela	Ukushisa Kuyazwela
Ukuncibilika kwamanzi	Incibilika Emanzini (>5 mg/ml)
Isikhathi Sokugcina.	Indawo epholile neyomile (2~8℃)
I-COA ne-MSDS	Iyatholakala
Ibhrendi	I-Ruifu Chemical

Imininingwane:

Izinto	Amazinga Wokuhlola	Imiphumela
Ukubukeka	I-Crystalline Powder emhlophe ukuya kokumhlophe	Iyahambisana
Ukuhlonza
1. UV	Ubukhulu 209, 248, 267, 310nm	Ufanelekile
2. Ububanzi be-IR	Ivumelana Nesakhiwo	Ufanelekile
3. Ukucwaswa kweChloride	Phambili Ukusabela	Ufanelekile
Amanzi nguKarl Fischer	9.0~10.5%	9.7%
Izinsalela ekushiseni	≤0.10%	0.03%
Izinsimbi Ezisindayo (Pb)	≤10ppm	<10ppm
I-Ondansetron Ehlobene Nenhlanganisela C	≤0.20%	0.09%
Inhlanganisela Ehlobene ne-Ondansetron D	≤0.10%	0.04%
Imidazole	≤0.20%	0.02%
2-Methylimidazole	≤0.20%	0.02%
I-Ondansetron Related Compound A	≤0.20%	0.05%
Okunye Ukungcola Okukodwa Okungaziwa	≤0.10%	0.07%
Ukungcola Okuphelele	≤0.50%	0.29%
I-Residual Solvent
I-Ethanol	≤5000ppm	240ppm
Isivivinyo	98.0~102.0% (Ibalwe ngesisekelo se-anhydrous)	99.81%
Isiphetho	Umkhiqizo uhloliwe futhi uthobelana nezicaciso

Iphakheji/Isitoreji/Ukuthumela ngomkhumbi:

Iphakheji:Ibhodlela, isikhwama se-Aluminium foil, 25kg/Cardboard Drum, noma ngokwezidingo zekhasimende.
Isimo Sesitoreji:Gcina esitsheni esivalwe ngci.Gcina endaweni epholile, eyomile (2~8℃) futhi enomoya omuhle kude nezinto ezingahambelani.Vikela ekukhanyeni nakumswakama.
Ukuthumela:Zilethe emhlabeni wonke ngendiza, yi-FedEx/DHL Express.Nikeza ukulethwa okusheshayo nokuthembekile.

Izinzuzo:

Amandla Anele: Izinsiza ezanele kanye nochwepheshe

Isevisi Yobuchwepheshe: Isevisi yokuthenga yokuma eyodwa

Iphakheji le-OEM: Iphakheji yangokwezifiso kanye nelebula iyatholakala

Ukulethwa Okusheshayo: Uma kungaphakathi kwesitoko, ukulethwa kwezinsuku ezintathu kuqinisekisiwe

Impahla Ezinzile: Gcina isitoko esinengqondo

Ukusekelwa Kwezobuchwepheshe: Isixazululo sezobuchwepheshe siyatholakala

Isevisi Yokuhlanganisa Ngokwezifiso: Isukela kumagremu kuye kumakhilo

Ikhwalithi Ephezulu: Kusungulwe uhlelo oluphelele lokuqinisekisa ikhwalithi

I-FAQ:

Indlela Yokuthenga?Sicela uxhumaneDr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com

Iminyaka engu-15 Yokuhlangenwe nakho?Sinesipiliyoni seminyaka engaphezu kwe-15 ekwakhiweni nasekuthumeleni kwamanye amazwe uhla olubanzi lwezinga eliphezulu lokuxhumanisa imithi noma amakhemikhali amahle.

Izimakethe Eziyinhloko?Thengisa emakethe yasekhaya, eNyakatho Melika, eYurophu, eNdiya, eKorea, eJapane, e-Australia, njll.

Izinzuzo?Ikhwalithi ephezulu, intengo ethengekayo, izinsizakalo ezichwepheshile nokusekelwa kobuchwepheshe, ukulethwa okusheshayo.

IkhwalithiIsiqiniseko?Isistimu yokulawula ikhwalithi eqinile.Imishini yobuchwepheshe yokuhlaziya ifaka i-NMR, LC-MS, GC, HPLC, ICP-MS, UV, IR, NOMA, KF, ROI, LOD, MP, Clarity, Solubility, Microbial limit test, njll.

Amasampula?Imikhiqizo eminingi inikeza amasampula wamahhala wokuhlolwa kwekhwalithi, izindleko zokuthumela kufanele zikhokhelwe amakhasimende.

Ukuhlolwa Kwemboni?Wamukelekile ekucwaningweni kwemboni.Sicela wenze i-aphoyintimenti kusengaphambili.

I-MOQ?Ayikho i-MOQ.I-oda elincane liyamukeleka.

Isikhathi sokuthumela? Uma kungaphakathi kwesitoko, ukulethwa kwezinsuku ezintathu kuqinisekisiwe.

Ezokuthutha?By Express (FedEx, DHL), by Air, by Sea.

Amadokhumenti?Ngemuva kwenkonzo yokuthengisa: I-COA, i-MOA, i-ROS, i-MSDS, njll.

Custom Synthesis?Ingahlinzeka ngezinsizakalo zokwenziwa ngokwezifiso ukuze zilingane kangcono nezidingo zakho zocwaningo.

Imigomo Yokukhokha?I-invoyisi ye-Proforma izothunyelwa kuqala ngemva kokuqinisekiswa kwe-oda, kufakwe nemininingwane yethu yasebhange.Inkokhelo nge-T/T (Telex Transfer), PayPal, Western Union, njll.

103639-04-9 - Ubungozi Nokuphepha:

Amakhodi Engozi
R25 - Kunobuthi uma ugwinywe
R36/37/38 - Ukucasula amehlo, uhlelo lokuphefumula kanye nesikhumba.
Incazelo Yokuphepha
S45 - Uma kwenzeka ingozi noma uzizwa ungaphilile, funa iseluleko sezokwelapha ngokushesha (bonisa ilebula noma nini lapho kunokwenzeka.)
I-S37/39 - Gqoka amagilavu afanelekile kanye nokuvikela iso/ubuso
S26 - Uma uthintana namehlo, geza ngokushesha ngamanzi amaningi futhi ufune iseluleko sezokwelapha.
Ama-ID e-UN UN 2811 6.1/PG 3
I-WGK Germany 3
I-RTECS FE6375500
I-HS Code 29339900
I-Hazard Class 6.1(a)
Ukupakisha Iqembu II

103639-04-9 - Isicelo:

I-Ondansetron Hydrochloride Dihydrate (i-CAS: 103639-04-9) i-serotonin ethile (5-HT3) ephikisana ne-receptor.I-Antiemetic.I-Ondansetron Hydrochloride Dihydrate isetshenziselwa ukuvimbela isicanucanu nokuhlanza okungase kubangelwe ukuhlinzwa, ukwelashwa ngamakhemikhali omdlavuza, noma ukwelashwa ngemisebe.I-5-HT3 receptor antagonists e-Ondansetron imithi eyinhloko esetshenziselwa ukwelapha nokuvimbela isicanucanu esibangelwa ngamakhemikhali kanye nokuhlanza kanye nesicanucanu nokuhlanza okubangelwa i-radiotherapy, ngokuvimbela izenzo zamakhemikhali emzimbeni.Ukusebenza kahle kungcono kune-metoclopramide kuyilapho kuthulile kancane kune-cyclizine noma i-droperidol.Nokho, kunomphumela omncane ekuhlanzeni okubangelwa ukugula kokunyakaza.Inganikezwa ngomlomo, ngokujova emsipha noma emthanjeni.

I-Ondansetron ne-Granisetron, i-Dolasetron ama-antiemetics amathathu avamile asetshenziswa emtholampilo, i-ondansetron iyisivimbeli se-serotonin (5-HT3) esisebenzayo esibuyiseleka emuva futhi esikhethayo, ku-α1, α2, β1, β2-adrenergic receptors kanye ne-histamine H1, H2 receptors, inomphumela omncane, kuma-H receptors, i-central and peripheral dopaminergic receptors, ayinawo umphumela ophikisayo, ingacindezela ukwelapha ngamakhemikhali kanye nesicanucanu nokuhlanza okubangelwa yi-radiotherapy.Uma kuqhathaniswa ne-metoclopramide, umphumela wayo we-antiemetic unamandla futhi awunakho ukusabela kwe-extrapyramidal.Ngokuhlanza okubangelwa i-cisplatin, i-cyclophosphamide, i-doxorubicin, njll. kungaveza umphumela we-antiemetic osheshayo futhi onamandla.Ayilungele kuphela ukwelapha isicanucanu nokuhlanza okubangelwa i-cytotoxic chemotherapy kanye nokwelashwa ngemisebe, kodwa futhi nokuvimbela nokwelapha isicanucanu nokuhlanza okubangelwa ukuhlinzwa.I-Ondansetron isebenza njengendawo yokuthutha phakathi kwenzwa ye-visceral afferent ecushiwe emgudwini wamathumbu kanye nasesikhungweni sokuhlanza ngaphakathi komgogodla, okuholela ekunyakazeni kwe-diaphragm nemisipha yesisu.I-Chemotherapy kanye nokwelashwa ngemisebe kungabangela ukukhululwa kwe-5-HT emathunjini futhi kubangele inzwa ye-vagus stimulation nge-5-HT3 receptor, ebangela i-reflex yokuhlanza.Lo mkhiqizo uvimba lokhu kuguqulwa okwenzekayo, ngesikhathi esifanayo uvimba ukuhlanza okubangelwa isenzo esimaphakathi.Indlela emayelana nesicanucanu nokuhlanza ngemuva kokuhlinzwa akwaziwa.I-Ondansetron ihlanganiswe ne-dexamethasonecan ingathuthukisa umphumela we-anti-emetic.

103639-04-9 - Imiphumela Engathandeki:

Lokhu kubangela ukuphuma kwe-vagal afferent, okwenza ukuhlanza.Lapho ibophezela kuma-receptors angu-5-HT3, i-ondansetron ivimba ukugqugquzelwa kwe-serotonin, ngakho-ke ukuhlanza, ngemva kwezisusa ze-emetogenic ezifana ne-cisplatin.Ubuhlungu bekhanda buwumphumela omubi obikwa njalo wale mithi.

103639-04-9 - Iphrofayela Yokuphepha:

Ubuthi ngomzila womthanjeni.Imiphumela ye-Human systemic ngomzila wokungena emthanjeni: i-jaundice.Uma ishiselwa ukuze ibole ikhipha umhwamuko onobuthi we-NOx.

103639-04-9 - Izidakamizwa Nokwelashwa Kwezilwane:

Isetshenziswa njenge-antiemetic lapho i-antiemetics evamile ingasebenzi, njengalapho unikeza i-cisplatin noma ezinye izimbangela zokuhlanza okungalawuleki.Ukusetshenziswa kwe-ondansetron emakati kunempikiswano ngandlela thize futhi abanye bathi akufanele isetshenziswe kulolu hlobo lwezilwane.

Ukusebenzisana kwezidakamizwa Ukusebenzelana okungaba yingozi nezinye izidakamizwa.

103639-04-9 - USP35 Okujwayelekile:

I-Ondansetron Hydrochloride iqukethe amaphesenti angekho ngaphansi kuka-98.0 futhi angeqi kumaphesenti angu-102.0 we-C18H19N3O·HCl, abalwe ngesisekelo se-anhydrous.

Ukupakisha nokugcina-Londoloza ezitsheni eziqinile, ezimelana nokukhanya.Gcina ku-25

, uhambo oluvunyelwe phakathi kuka-15

futhi 30

Amazinga ereferensi we-USP <11>-

USP Ondansetron Hydrochloride RS

I-USP Ondansetron Inhlanganisela Ehlobene A RS

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

I-USP Ondansetron Resolution Mixture RS

I-Ondansetron hydrochloride ecishe ibe ngu-0.4% w/w yakho kokubili inhlanganisela ehlobene ne-ondansetron A kanye ne-6,6¢-methylene bis--[(1,2,3,9-tetrahydro-9-methyl-3--[(2-methyl-1H--) imidazol-1-yl)-methyl]-4H-carbazol-4-one)]

I-USP Ondansetron Ehlobene Inhlanganisela C RS
I-1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-one.

I-USP Ondansetron Inhlanganisela Ehlobene D RS
I-1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one.

Ukuhlonza-

A: I-Infrared Absorption <197M>.

B: Chaza u-20 mg ku-2 mL wamanzi, engeza u-1 mL we-2 M nitric acid, kanye nesihlungi: i-filtrate isabela ekuhlolweni kwe-Chloride <191>.

Amanzi, Indlela Ia <921>: phakathi kuka-9.0% no-10.5%.

Izinsalela ekushiseni <281>: hhayi ngaphezu kuka-0.1%.

Umkhawulo we-ondansetron ehlobene ne-D-

Isigaba seselula- Lungiselela ingxube ehlungiwe nesusiwe ka-0.02 M monobasic potassium phosphate (eyalungiswa ngaphambilini nge-1 M sodium hydroxide kuya ku-pH engu-5.4) kanye ne-acetonitrile (80:20).Yenza izinguquko uma kudingeka (bona Ukufaneleka Kwesistimu ngaphansi kwe-Chromatography <621>).

Isixazululo esijwayelekile-Chaza isamba esikalwe ngokunembile se-USP Ondansetron Ehlobene Nenhlanganisela D RS esigabeni Seselula, futhi uhlambulule ngobuningi, nangesinyathelo uma kudingeka, ngesigaba Seselula ukuze uthole isixazululo esinokugxila okwaziwayo okungaba ngu-0.4 µg ngemL ngayinye.

Isixazululo sokufaneleka kwesistimu-Chaza amanani afanelekile e-USP Ondansetron Related Compound D RS kanye ne-USP Ondansetron Related Compound C RS esigabeni se-Mobile, futhi uhlambulule ngobuningi, nangesinyathelo uma kunesidingo, ngesigaba Seselula ukuze uthole isixazululo esinokugxila okungaba ngu-0.6 µg ngemL ngayinye. kanye no-1 µg ngemL, ngokulandelana.

Isixazululo sokuhlola-Dlulisa cishe u-50 mg we-Ondansetron Hydrochloride, ukalwe ngokunembile, uye ku-100-mL ye-volumetric flask, ncibilika futhi uhlambulule ngesigaba Seselula siye kuvolumu, bese uxuba.

Isistimu ye-Chromatographic (bona i-Chromatography <621>)-I-chromatograph ewuketshezi ifakwe umtshina ongu-328-nm kanye nekholomu engu-4.6-mm × 25-cm equkethe ukupakisha i-L10.Izinga lokugeleza licishe libe ngu-1.5 mL ngomzuzu.I-Chromatograph isixazululo sokufaneleka kweSistimu, futhi urekhode izimpendulo eziphezulu njengoba kuqondiswe kuNqubo: izikhathi zokugcinwa okuhlobene zimayelana ne-0.8 yenhlanganisela C ehlobene ne-ondansetron kanye ne-1.0 yenhlanganisela D ehlobene ne-ondansetron;kanye nokulungiswa, R, phakathi kwenhlanganisela C ehlobene ne-ondansetron kanye nenhlanganisela D ehlobene ne-ondansetron ayikho ngaphansi kuka-1.5.I-Chromatograph isixazululo Esijwayelekile, futhi urekhode izimpendulo eziphezulu njengoba kuqondiswe kuNqubo: ukusebenza kahle kwekholomu okunqunywe kusukela kunani lokuhlaziya alikho ngaphansi kwamapuleti etiyori angama-400;futhi ukuchezuka okujwayelekile okuhlobene kwemijovo eyimpinda akukho ngaphezu kuka-2.0%.

Inqubo- Jova ngokwehlukana amavolumu alinganayo (cishe ama-20 µL) esixazululo Esijwayelekile kanye nesixazululo sokuhlola ku-chromatograph, rekhoda ama-chromatogram, futhi ulinganise izimpendulo zeziqongo ezinkulu.Bala iphesenti lenhlanganisela ye-ondansetron D engxenyeni ye-Ondansetron Hydrochloride ethathwe ifomula:

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

lapho u-C eyingqikithi, ngo-mg ngemL, ye-USP Ondansetron Ehlobene Inhlanganisela D RS kusixazululo Esijwayelekile;W yisisindo, ngo-mg, se-Ondansetron Hydrochloride esithathwe ukuze kulungiswe ikhambi Lokuhlola;futhi i-rU kanye ne-rS yizindawo eziphakeme kakhulu ezitholakala kusixazululo sokuhlola kanye nesisombululo Esijwayelekile, ngokulandelana: akutholakali ngaphezu kuka-0.10%.

Ubumsulwa beChromatographic-

indlela i-

Isixazululo sokuxazulula-Chaza inani le-USP Ondansetron Resolution Mixture RS ku-methanol, futhi uhlambulule ngobuningi, futhi ngokwesinyathelo uma kunesidingo, nge-methanol ukuze uthole isixazululo esinokugxila okwaziwayo okungu-12.5 mg ngemL ngayinye.

Izisombululo ezijwayelekile-Chaza isamba esikalwe ngokunembile se-USP Ondansetron Hydrochloride RS ku-methanol, bese uxuba ukuze uthole isixazululo esinokugxila okwaziwayo okungaba ngu-0.25 mg nge-mL ngayinye.Kancane kancane hlambulula lesi sixazululo nge-methanol ukuze uthole izixazululo Ezijwayelekile, ezibekwe ngezansi ngencwadi, ezinamaculo alandelayo:

Isixazululo esijwayelekile	Ukunciphisa	Ukugxila (µg RS per mL)	Iphesenti (%, uma kuqhathaniswa nesifanekiso sokuhlola)
A	(1 ku-5)	50	0.4
B	(1 ku-10)	25	0.2
C	(1 ku-20)	12.5	0.1

Isixazululo sokuhlola-Chaza inani elinesisindo esinembile se-Ondansetron Hydrochloride ku-methanol ukuze uthole isixazululo esiqukethe u-12.5 mg ngemL ngayinye.Inqubo-Ngokuhlukana sebenzisa u-20 µL wesixazululo sokuhlola, u-20 µL wesisombululo ngasinye Esijwayelekile, kanye no-20 µL wesixazululo Sokuxazulula kupuleti le-chromatographic elendlalelo encane (bona i-Chromatography621) embozwe ngesendlalelo esingu-0.25-mm sengxube yejeli ye-silica yechromatographic.Yakha i-chromatogram ohlelweni lokuncibilikisa oluhlanganisa ingxube ye-chloroform, i-ethyl acetate, i-methanol, ne-ammonium hydroxide (90:50:40:1) kuze kube yilapho i-solvent yangaphambili isihamba cishe izingxenye ezintathu kwezine zobude bepuleti.Susa ipuleti ekamelweni, maka i-solvent ngaphambili, futhi uvumele i-solvent ihwamuke.Hlola ipuleti ngaphansi kokukhanya kwe-UV yamaza amafushane amaza: ukulungiswa okuphelele kwezingxenye ezintathu zendawo yesisombululo sokuxazulula kuyatholakala.Qhathanisa ukuqina kwanoma yimaphi amachashazi esibili abonwe ku-chromatogram yesisombululo sokuhlola nalawo amachashazi ayinhloko kuma-chromatogram ezixazululo Ezijwayelekile: noma iyiphi indawo yesibili evela ku-chromatogram yesixazululo sokuhlola enenani le-RF elihambisana nalelo lesibili eliphakeme kakhulu. indawo yesixazululo Sokuxazulula ayinkulu noma iqine kakhulu kunendawo eyinhloko etholwe kusixazululo Esijwayelekile A (0.4%);futhi ayikho enye indawo yesibili evela ku-chromatogram yesisombululo Sokuhlola inkulu noma iqine kakhulu kunendawo eyinhloko etholwe kusixazululo Esijwayelekile B (0.2%).

indlela ii-

Isigaba seselula kanye nesistimu ye-Chromatographic-Qhubeka njengoba kuqondiswe ku-Assay.

Isixazululo esijwayelekile-Qhubeka njengoba kuqondiswe ekulungiseleleni Okujwayelekile ku-Assay.

Isixazululo sokuhlola-Sebenzisa ukulungiswa kwe-Assay.

Inqubo-Ngokuhlukile jova amavolumu alinganayo (cishe u-10 µL) wesisombululo Esijwayelekile kanye nesixazululo sokuhlola ku-chromatograph, rekhoda ama-chromatogram, futhi ulinganise izimpendulo eziphezulu.Bala iphesenti lokungcola ngakunye engxenyeni ye-Ondansetron Hydrochloride ethathwe ifomula:

50,000(C/W)(1/F)(ri / rS)
lapho u-C eyingqikithi, ngo-mg nge-mL ngayinye, ye-USP Ondansetron Hydrochloride RS kusixazululo Esijwayelekile;W yisisindo, ngo-mg, se-Ondansetron Hydrochloride esithathwe ukuze kulungiswe ikhambi Lokuhlola;F iyisici sokuphendula esihlobene sokungcola njengoba kuchazwe kuthebula elihambisana nalesi sihloko;i-ri iyindawo ephakeme kakhulu yokungcola ngakunye kusixazululo sokuhlola;futhi i-rS iyindawo ephakeme kakhulu ye-ondansetron etholwe kusixazululo Esijwayelekile: ihlangabezana nezimfuneko ezinikezwe kuthebula elihambisana nalesi sihloko.

Igama Lenhlanganisela	Isikhathi Sokugcina Esihlobene	Isihlobo Impendulo Isici	Umkhawulo (%)
I-Ondansetron ehlobene ne-C	ngo 0.32	1.2	0.2
I-Ondansetron ehlobene ne-compound D*	ngo-0.34	-	0.1
Imidazole	ngo 0.49	0.3	0.2
2-methylimidazole	cishe 0.54	0.4	0.2
Ondansetron	1.0	-	-
I-Ondansetron ehlobene ne-compound A	cishe 1.10	0.8	0.2
Akwaziwa	-	1.0	0.1
Isamba	-	-	0.5
* Kulinganiselwe ekuhlolweni komkhawulo we-ondansetron ehlobene ne-compound D.

Isivivinyo-

Isigaba seselula-Lungiselela ingxube ehlungiwe nesusiwe ka-0.02 M monobasic sodium phosphate (eyalungiswa ngaphambilini nge-1 M sodium hydroxide kuya ku-pH engu-5.4) kanye ne-acetonitrile (50:50).Yenza izinguquko uma kudingeka (bona Ukufaneleka Kwesistimu ngaphansi kwe-Chromatography <621>).

Ukulungiselela okujwayelekile-Chaza isamba esikalwe ngokunembile se-USP Ondansetron Hydrochloride RS esigabeni se-Mobile, futhi uhlambulule ngobuningi, nangesinyathelo uma kudingeka, ngesigaba Seselula ukuze uthole isixazululo esinokugxila okwaziwayo okungaba ngu-90 µg ngemL ngayinye.

Isixazululo sokufaneleka kwesistimu-Chaza amanani afanelekile e-USP Ondansetron Hydrochloride RS kanye ne-USP Ondansetron Related Compound A RS esigabeni se-Mobile, futhi uhlambulule ngobuningi, nangesinyathelo uma kunesidingo, ngesigaba Seselula ukuze uthole isixazululo esiqukethe cishe u-90 µg ngemL kanye no-20 µg ngemL. , ngokulandelana.

Ukulungiselela i-assay-Dlulisa cishe u-45 mg we-Ondansetron Hydrochloride, ukalwe ngokunembile, uye ku-50-mL ye-volumetric flask, ncibilika futhi uhlambulule ngesigaba se-Mobile kuya kuvolumu, bese uxuba.Pipetha u-5.0 mL walesi sixazululo eflaskini yevolumu engu-50-mL, hlambulula ngesigaba seselula ukuya kuvolumu, bese uxuba.

Isistimu ye-Chromatographic (bona i-Chromatography <621>)-I-chromatograph ewuketshezi ifakwe umtshina ongu-216-nm kanye nekholomu engu-4.6-mm × 25-cm equkethe ukupakisha i-L10.Izinga lokugeleza licishe libe ngu-1.5 mL ngomzuzu.I-Chromatograph isixazululo sokufaneleka Kwesistimu, futhi urekhode izimpendulo eziphezulu njengoba kuqondiswe Inqubo: izikhathi zokugcinwa okuhlobene cishe zingu-1.0 ku-ondansetron kanye no-1.1 kwenhlanganisela ehlobene ne-odansetron A;kanye nokulungiswa, R, phakathi kwenhlanganisela ehlobene ne-ondansetron A kanye ne-ondansetron ayikho ngaphansi kuka-1.5.I-Chromatograph ukulungiselelwa Okujwayelekile, futhi urekhode izimpendulo eziphezulu njengoba kuqondiswe kuNqubo: isici somsila asingaphezu kuka-2.0;futhi ukuchezuka okujwayelekile okuhlobene kwemijovo eyimpinda akukho ngaphezu kuka-1.5%.

Inqubo-Ngokuhlukile jova amavolumu alinganayo (cishe u-10 µL) wokulungiswa Okujwayelekile kanye nokulungiswa kwe-Assay ku-chromatograph, rekhoda ama-chromatogram, futhi ulinganise izimpendulo zeziqongo ezinkulu.Bala inani, ngo-mg, le-C18H19N3O·HCl engxenyeni ye-Ondansetron Hydrochloride ethathwe ifomula:

500C(rU / rS)
lapho u-C eyingqikithi, ngo-mg nge-mL ngayinye, ye-USP Ondansetron Hydrochloride RS ekulungiseleleni Okujwayelekile;futhi i-rU ne-rS yizindawo eziphakeme kakhulu ezitholwe ekulungiselelweni kwe-Assay nasekulungiseleleni Okujwayelekile, ngokulandelanayo.

103639-04-9 - Indlela Yokukhiqiza:

Indlela yoku-1: Ngemva kokusabela kwe-2-Bromoaniline kanye1,3-Cyclohexanedione, i-derivative ye-tetrahydrocarbazole iyakhiwa, futhi i-compound (III) itholakala ngokusabela nge-dimethylamine ne-diformaldehyde, futhi yethula i-dimethylaminomethyl endaweni ye-2.I-3.80G ye-compound (III) yasabela nge-methyl iodide ukunikeza u-5.72g wenhlanganisela (IV) ngokuhlukanisa i-amino chain chain group ngenkathi yethula iqembu le-methyl endaweni 9. 2.0g yenhlanganisela (IV) kanye ne-2-methyl-1h -imidazole yaphendulwa ku-dimethylformamide ngokushukumisa ku-95 ℃.Ukuze uthole i-0.60G ye-Ondansetron.

Indlela yesi-2: Ukusabela kwe-cyclohexanone ne-phenylhydrazine kunikeze i-tetrahydrocarbazole ngesivuno esingu-85%.Yiqede ku-tetrahydrofuran nasemanzini, engeza u-2,3 Dropwise ku-0 °c ku-nitrogen, Isixazululo se-5, 6-tetrachloro-1,4-benzoquinone ku-tetrahydrofuran sashukunyiswa ukunikeza umkhiqizo we-oxidation (II) ngesivuno esingu-67.4%.I-Compound (II), i-ethanol, i-hydrochloric acid egxilile, i-paraformaldehyde ne-dimethylamine hydrochloride zahlanganiswa kabusha.Ngemuva kokwelashwa, umkhiqizo (V) watholwa ngokungeza i-hydrochloric acid egxilile ku-acetone futhi inyakaze ku-50 ℃.Ngesivuno esingu-71.7%.I-Compound (V) kanye ne-2-methylimidazole yasabela emanzini ngo-110 ℃.Ukuthola inhlanganisela (VI) ngesivuno esingu-70.9%.I-Compound (VI), i-methyl iodide kanye ne-potassium carbonate kwanyakaziswa ekamelweni lokushisa kwaze kwaba yilapho okuqinile kuyanyamalala.Yayithelwa emanzini, yanyakaziswa, yahlungwa, yagezwa ngamanzi, yaphinde yahlanganiswa ne-methanol ukuze ithole i-ondansetron ngesivuno esingu-57.2%.Yiqede ngengxube ye-acetone namanzi, Ngokungeza i-hydrochloric acid egxilile ekuphenduleni, i-ondansetron hydrochloride dihydrate itholwe ngesivuno esingu-92.6%.

Indlela yesi-3: i-compound (II), i-potassium carbonate, i-acetone ne-dimethyl sulfate yashukunyiswa ekamelweni lokushisa.ICompound (VII) itholwe ngesivuno sama-91%.I-Compound (VII) yachithwa ku-ethanol futhi ingxube ye-paraformaldehyde yomuntu kanye ne-dimethylamine hydrochloride yengezwe ezingxenyeni ezingaphansi kwe-reflux.I-refluxing.Ngemuva kokwelashwa, inhlanganisela (VIII) itholwe ngesivuno esingu-67%.(Viii) incibilike ku-ethanol engena-hydrous, igesi ye-hydrogen chloride, i-hydrochloride yayo.I-hydrochloride yengezwe emanzini futhi i-2 yengezwa ku-50 ℃.I-Methylimidazole, i-ondansetron refluxing, ikhiqiza u-70%.Yachithwa ku-isopropanol, emanzini kanye ne-hydrochloric acid egxilile, futhi yashukunyiswa ekamelweni lokushisa ukuze ithole i-ondansetron hydrochloride dihydrate ngesivuno esingu-90.5%.