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

Tlhaloso e Khutšoanyane:

Lebitso la lik'hemik'hale: Ondansetron Hydrochloride Dihydrate

CAS: 103639-04-9

Tekanyetso: 98.0 ~ 102.0% (E baloa motheong oa anhydrous)

Ponahalo: Phofo ea Crystalline e tšoeu kapa e sa Tšoeu

A Specific Serotonin (5-HT3) Mohanyetsi oa Moamoheli.Antiemetic

Ikopanye le: Dr. Alvin Huang

Mobile/Wechat/WhatsApp: +86-15026746401

E-Mail: alvin@ruifuchem.com

Re romelle lengolo-tsoibila

Lintlha tsa Sehlahisoa

Lihlahisoa tse Amanang

Li-tag tsa Sehlahisoa

Tlhaloso:

Shanghai Ruifu Chemical ke moetsi ea ka sehloohong oa Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) e nang le boleng bo phahameng.Ruifu e ka fana ka lits'ebeletso tsa lefats'e ka bophara, theko ea tlholisano, ts'ebeletso e ntle haholo, palo e nyane le e ngata e fumanehang.Reka Ondansetron Hydrochloride Dihydrate,Please contact: alvin@ruifuchem.com

Li-Intermediate tse Amanang:

Li-Intermediate tse Amanang tsa Ondansetron Hydrochloride Dihydrate

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

Lintho tsa Lik'hemik'hale:

Lebitso la Lik'hemik'hale	Ondansetron Hydrochloride Dihydrate
Litlhaloso tse tšoanang	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
Boemo ba Setoko	Ho Stock, Commercial Scale
Nomoro ea CAS	103639-04-9 (Dihydrate)
E amanang le CAS RN	99614-02-5 (Base) & 99614-01-4 (Anhydrous)
Foromo ea limolek'hule	C18H19N3O·HCl·2H2O
Boima ba Molek'hule	365.86 g/mol
Melting Point	176.0 ho isa ho 180.0 ℃
E hloahloa	Mocheso o Mamela
Ho qhibiliha ha Metsi	E qhibiliha ka Metsing (> 5 mg/ml)
Mocheso oa polokelo.	Sebaka se pholileng le se omileng (2~8℃)
COA & MSDS	E fumaneha
Brand	Ruifu Chemical

Litlhaloso:

Lintho	Maemo a Tlhahlobo	Liphetho
Ponahalo	Phofo ea Crystalline e tšoeu ho isa ho e tšoeu	E lumellana
Boitsebiso
1. UV	Max 209, 248, 267, 310nm	Ea tšoanelehang
2. IR spectrum	E Ikamahanya le Sebopeho	Ea tšoanelehang
3. Khethollo ea Chloride	Tsoela Pele Karabelo	Ea tšoanelehang
Metsi ka Karl Fischer	9.0~10.5%	9.7%
Masalla a ho Ignition	≤0.10%	0.03%
Litšepe tse boima (Pb)	≤10ppm	<10ppm
Motsoako o amanang le Ondansetron C	≤0.20%	0.09%
Motsoako o amanang le Ondansetron D	≤0.10%	0.04%
Imidazole	≤0.20%	0.02%
2-Methylimidazole	≤0.20%	0.02%
Ondansetron Related Compound A	≤0.20%	0.05%
Tšilafalo e 'ngoe e sa Tsejoeng e le 'Ngoe	≤0.10%	0.07%
Litšila ka Kakaretso	≤0.50%	0.29%
Residual Solvent
Ethanol	≤5000ppm	240ppm
Tlhahlobo	98.0 ~ 102.0% (E baloa motheong oa anhydrous)	99.81%
Qetello	Sehlahisoa se lekoa 'me se lumellana le litlhaloso

Sephutheloana/Bobolokelo/Ho tsamaisa ka sekepe:

Sephutheloana:Botlolo, Aluminium foil bag, 25kg/Cardboard Drum, kapa ho ea ka tlhokahalo ea moreki.
Boemo ba polokelo:Boloka ka setshelo se koetsoeng ka thata.Boloka sebakeng se phodileng, se omeletseng (2~8℃) le se nang le moya o hlwekileng hole le dintho tse sa dumellaneng.Sireletsa leseli le mongobo.
Ho tsamaisa ka sekepe:Tsamaisa lefatšeng ka bophara ka sefofane, ka FedEx / DHL Express.Fana ka thomello e potlakileng le e tšepahalang.

Melemo:

Bokhoni bo lekaneng: Lisebelisoa le litsebi tse lekaneng

Tšebeletso ea profeshenale: Tšebeletso e le 'ngoe ea ho reka

Sephutheloana sa OEM: Sephutheloana sa tloaelo le leibole lia fumaneha

Tlhahiso e potlakileng: Haeba e le ka har'a setoko, ho netefalitsoe hore ho tsamaisoa matsatsi a mararo

Thepa e tsitsitseng: Boloka thepa e lekaneng

Tšehetso ea Theknoloji: Tharollo ea theknoloji e teng

Tšebeletso e Tloaelehileng ea ho Kopanya: Ho tloha ho ligrama ho isa ho lik'hilograma

Boleng bo Phahameng: Ho thehile tsamaiso e felletseng ea netefatso ea boleng

LBH:

Mokhoa oa ho Reka?Ka kopo ikopanyeDr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com

Phihlelo ea Lilemo Tse 15?Re na le boiphihlelo ba lilemo tse fetang 15 ho etsa le ho romella kantle ho naha mefuta e mengata e fapaneng ea li-intermediate tsa boleng bo holimo tsa meriana kapa lik'hemik'hale tse ntle.

Limmaraka tse ka Sehloohong?Rekisetsa 'maraka oa lapeng, Amerika Leboea, Europe, India, Korea, Japane, Australia, joalo-joalo.

Melemo?Boleng bo phahameng, theko e theko e tlaase, lits'ebeletso tsa litsebi le ts'ehetso ea tekheniki, phano e potlakileng.

BolengTiisetso?Tsamaiso e thata ea taolo ea boleng.Lisebelisoa tsa profeshenale bakeng sa tlhahlobo li kenyelletsa NMR, LC-MS, GC, HPLC, ICP-MS, UV, IR, OR, KF, ROI, LOD, MP, Clarity, Solubility, Microbial limit test, joalo-joalo.

Mehlala?Lihlahisoa tse ngata li fana ka mehlala ea mahala bakeng sa tlhahlobo ea boleng, litšenyehelo tsa ho tsamaisa thepa li lokela ho lefshoa ke bareki.

Feme Audit?Ho amoheloa ha fektheri.Ke kopa o etse kopano esale pele.

MOQ?Ha ho MOQ.Taelo e nyenyane e amoheleha.

Nako ea thomello? Haeba ka har'a setoko, ho netefalitsoe hore ho tsamaisoa ka matsatsi a mararo.

Lipalangoang?Ka Express (FedEx, DHL), ka Moea, ka Leoatle.

Litokomane?Ka mor'a tšebeletso ea thekiso: COA, MOA, ROS, MSDS, joalo-joalo e ka fanoa.

Custom Synthesis?E ka fana ka lits'ebeletso tsa tloaelo tsa ho kopanya ho lekana hantle litlhoko tsa hau tsa lipatlisiso.

Litefiso Melao?Invoice ea Proforma e tla romelloa pele kamora netefatso ea odara, e kenyellelitseng tlhahisoleseling ea rona ea banka.Tefo ka T/T (Telex Transfer), PayPal, Western Union, joalo-joalo.

103639-04-9 - Kotsi le Tšireletseho:

Likhoutu tsa Kotsi
R25 - E chefo ha e koetsoe
R36/37/38 - Ho hlohlona mahlong, tsamaiso ya moya le letlalo.
Tlhaloso ea Tšireletseho
S45 - Ha ho ka etsahala kotsi kapa ha o ikutlwa o sa phele hantle, batla keletso ho ngaka hanghang (bontsha leibole neng kapa neng ha ho kgoneha.)
S37/39 - Apara liatlana tse loketseng le tšireletso ea mahlo / sefahleho
S26 - Ha u kopana le mahlo, hlatsoa hang-hang ka metsi a mangata 'me u batle keletso ea bongaka.
Li-ID tsa UN UN 2811 6.1/PG 3
WGK Jeremane 3
RTECS FE6375500
HS Code 29339900
Sehlopha sa Likotsi 6.1(a)
Sehlopha sa ho paka II

103639-04-9 - Kopo:

Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) ke mohanyetsi ea khethehileng oa serotonin (5-HT3).Antiemetic.Ondansetron Hydrochloride Dihydrate e sebelisetsoa ho thibela ho nyekeloa ke pelo le ho hlatsa tse ka bakoang ke ho buuoa, chemotherapy ea kankere, kapa phekolo ea mahlaseli.Bahanyetsi ba 5-HT3 receptor ho Ondansetron ke lithethefatsi tse ka sehloohong tse sebelisoang ho phekola le ho thibela ho nyekeloa ke pelo ho bakoang ke chemotherapy le ho hlatsa le ho nyekeloa ke pelo ho bakoang ke radiotherapy le ho hlatsa, ka ho thibela liketso tsa lik'hemik'hale 'meleng.Ts'ebetso e ntle ho feta metoclopramide ha e ntse e khutsisa ho feta cyclizine kapa droperidol.Leha ho le joalo, ha e na phello e fokolang tabeng ea ho hlatsa ho bakoang ke boloetse ba ho tsamaea.E ka fanoa ka molomo, ka ente ka har'a mesifa kapa mothapong.

Ondansetron le Granisetron, Dolasetron ke li-antiemetics tse tharo tse tloaelehileng tse sebelisoang tleliniking, ondansetron ke serotonin e sebetsang hantle (5-HT3) receptor blocker e khonang ho khutlisetsoa morao le ho khetha, bakeng sa α1, α2, β1, β2-adrenergic receptors le histamine H1, H2 receptors, e na le phello e fokolang, bakeng sa li-receptors tsa H, li-receptors tse bohareng le tsa peripheral dopaminergic, ha e na phello e hanyetsang, e ka hatella chemotherapy le ho nyekeloa ke pelo le ho hlatsa ho bakoang ke radiotherapy.Ha e bapisoa le metoclopramide, phello ea eona ea antiemetic e matla ebile ha e na karabelo ea extrapyramidal.Bakeng sa ho hlatsa ho bakoang ke cisplatin, cyclophosphamide, doxorubicin, joalo-joalo e ka hlahisa phello e potlakileng le e matla ea antiemetic.Ha e loketse feela kalafo ea ho nyekeloa ke pelo le ho hlatsa ho bakoang ke cytotoxic chemotherapy le radiation therapy, empa hape le bakeng sa thibelo le kalafo ea ho nyekeloa ke pelo le ho hlatsa ho bakoang ke ho buuoa.Ondansetron e sebetsa e le sebaka sa lipalangoang pakeng tsa methapo ea visceral afferent e sebelisoang ka har'a pampiri ea mala le setsi sa ho hlatsa ka har'a mokokotlo oa mokokotlo, e leng se lebisang ho ho sisinyeha ha diaphragm le mesifa ea mpa.Kalafo ea chemotherapy le radiation e ka etsa hore mala a 5-HT a lokolloe 'me a etse hore vagus e hlahisoe ke 5-HT3 receptor, e bakang ho hlatsa reflex.Sehlahisoa sena se thibela reflex ena ho etsahala, ka nako e ts'oanang se thibela ho hlatsa ho bakoang ke ketso e bohareng.Mokhoa o mabapi le ho nyekeloa ke pelo le ho hlatsa ka mor'a ts'ebetso ha o tsejoe.Ondansetron hammoho le dexamethasonecan e ka ntlafatsa phello ea anti-emetic.

103639-04-9 - Litlamorao:

Sena se etsa hore vagal afferent a hlatsoe, 'me a hlatse.Ha e tlama li-receptor tsa 5-HT3, ondansetron e thibela ho tsosoa ha serotonin, ka hona ho hlatsa, ka mor'a tšusumetso ea emetogenic e kang cisplatin.Ho opeloa ke hlooho ke litlamorao tse mpe tse tlalehiloeng khafetsa tsa meriana ena.

103639-04-9 - Boemo ba Polokeho:

Chefo ka tsela ea methapo.Human systemic effects by intravenous route: jaundice.Ha e chesetsoa ho bola e ntša mouoane o chefo oa NOx.

103639-04-9 - Lithethefatsi le Liphekolo tsa Ngaka ea liphoofolo:

E sebelisoa e le antiemetic ha meriana e tloaelehileng ea antiemetic e sa sebetse, joalo ka ha u fana ka cisplatin kapa lisosa tse ling tsa ho hlatsa ho sa feleng.Tšebeliso ea ondansetron ho likatse e batla e phehisana khang 'me ba bang ba re ha ea lokela ho sebelisoa ho mofuta ona.

Ho sebelisana le lithethefatsi Tšebelisano e ka bang kotsi le lithethefatsi tse ling.

103639-04-9 - USP35 Maemo:

Ondansetron Hydrochloride e na le liphesente tse seng ka tlase ho 98.0 mme ha li fete liperesente tse 102.0 tsa C18H19N3O·HCl, tse baloang ho latela anhydrous.

Ho paka le ho boloka-Ho boloka ka har'a lijana tse thata, tse sa keneleng khanya.Boloka ho 25

, maeto a lumelletsoeng pakeng tsa 15

le 30

USP Reference standards <11>-

USP Ondansetron Hydrochloride RS

USP Ondansetron Related Compound A RS

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

USP Ondansetron Resolution Mixture RS

Ondansetron hydrochloride e nang le hoo e ka bang 0.4% w/w ea motsoako o amanang le ondansetron A le 6,6¢-methylene bis--[(1,2,3,9-tetrahydro-9-methyl-3--[(2-methyl-1H-) imidazol-1-yl)-methyl]-4H-carbazol-4-one)]

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

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

Boitsebiso-

A: Infrared Absorption <197M>.

B: Hlakola 20 mg ka 2 mL ea metsi, eketsa 1 mL ea 2 M nitric acid, le sefa: filtrate e arabela tekong ea Chloride <191>.

Metsi, Mokhoa oa Ia <921>: pakeng tsa 9.0% le 10.5%.

Masala a ho khantša <281>: eseng ho feta 0.1%.

Moeli oa motsoako o amanang le ondansetron D-

Mobile phase- Lokisetsa motsoako o tlhotliloeng le o senyehileng oa 0.02 M monobasic potassium phosphate (e neng e fetotsoe pele ka 1 M sodium hydroxide ho pH ea 5.4) le acetonitrile (80:20).Etsa litokiso ha ho hlokahala (sheba Tšebeliso ea Sistimi tlas'a Chromatography <621>).

Tharollo e tloahelehileng-Hlakola tekanyo e lekantsoeng e nepahetseng ea USP Ondansetron Related Compound D RS in Mobile phase, 'me u hlapolle ka bongata, le ha ho hlokahala, ka Mobile phase ho fumana tharollo e nang le khokahanyo e tsebahalang ea hoo e ka bang 0.4 µg ka mL.

Tharollo ea ho tšoaneleha ha Sistimi-Hlakola litekanyo tse loketseng tsa USP Ondansetron Related Compound D RS le USP Ondansetron Related Compound C RS in Mobile phase, 'me u hlapolle ka bongata, le ha ho hlokahala, ka karolo ea Mobile ho fumana tharollo e nang le khatello ea maikutlo e ka bang 0.6 µg ka mL. le 1 µg ka mL, ka ho latellana.

Tharollo ea teko-Fetisetsa hoo e ka bang 50 mg ea Ondansetron Hydrochloride, e lekantsoeng ka nepo, ho botlolo ea volumetric ea 100-mL, qhibiliha le ho hlapolla ka Mobile phase ho ea bophahamong, le ho kopanya.

Chromatographic system (bona Chromatography <621>) -Mokelikeli oa chromatograph o na le mochine oa 328-nm le kholomo ea 4.6-mm × 25-cm e nang le packing L10.Sekhahla sa phallo ke hoo e ka bang 1.5 mL ka motsotso.Chromatograph the System suitability solution, 'me u tlalehe likarabo tsa tlhōrō joalokaha li laetsoe bakeng sa Tsamaiso: linako tse amanang le ho boloka li ka bang 0.8 bakeng sa motsoako o amanang le ondansetron C le 1.0 bakeng sa motsoako o amanang le ondansetron D;le qeto, R, pakeng tsa motsoako o amanang le ondansetron C le motsoako o amanang le ondansetron D ha o ka tlaase ho 1.5.Chromatograph the Standard solution, 'me u tlalehe likarabo tsa tlhōrō joalokaha li laetsoe bakeng sa Tsamaiso: katleho ea kholomo e khethiloeng ho tloha tlhōrōng ea analyte ha e ka tlase ho lipoleiti tsa theory tsa 400;'me kheloha e lekanyelitsoeng bakeng sa liente tse ikatisang ha e fete 2.0%.

Ts'ebetso- Kenya li-volumes tse lekanang (hoo e ka bang 20 µL) tsa tharollo e tloaelehileng le tharollo ea Teko ka har'a chromatograph, rekota li-chromatogram, 'me u lekanye likarabo tsa litlhoro tse kholo.Bala peresente ea motsoako o amanang le ondansetron D karolong ea Ondansetron Hydrochloride e nkiloeng ka foromo:

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

moo C e leng mahloriso, ka mg ka mL, ea USP Ondansetron Related Compound D RS ka tharollo ea Standard;W ke boima, ka mg, ea Ondansetron Hydrochloride e nkiloeng ho lokisetsa tharollo ea Tlhahlobo;'me rU le rS ke libaka tse phahameng tse fumanoang ho tsoa ho Tharollo ea Teko le Tharollo ea Standard, ka ho latellana: ha ho na ho feta 0.10% e fumanoang.

Bohloeki ba Chromatographic-

mokhoa oa i-

Resolution solution-Hlakola bongata ba USP Ondansetron Resolution Mixture RS ka methanol, 'me u hlapolle ka bongata, le ha ho hlokahala, ka methanol ho fumana tharollo e nang le motsoako o tsejoang oa 12.5 mg ka mL.

Standard solutions-Hlakola tekanyo e lekantsoeng hantle ea USP Ondansetron Hydrochloride RS ka methanol, 'me u kopanye ho fumana tharollo e nang le motsoako o tsejoang oa hoo e ka bang 0.25 mg ka mL.Hlakola tharollo ena ka methanol ka bongata ho fumana litharollo tse tloaelehileng, tse boletsoeng ka tlase ka lengolo, tse nang le lipina tse latelang:

Tharollo e tloaelehileng	Phapollo	Khokahano (µg RS ka mL)	Peresente (%, ha e bapisoa le mohlala oa teko)
A	(1 ho 5)	50	0.4
B	(1 ho tse 10)	25	0.2
C	(1 ho tse 20)	12.5	0.1

Tharollo ea teko-Hlakola palo e lekantsoeng ka nepo ea Ondansetron Hydrochloride ka methanol ho fumana tharollo e nang le 12.5 mg ka mL.Mokhoa - Sebelisa 20 µL ea Tharollo ea Teko ka thoko, 20 µL ea tharollo e 'ngoe le e 'ngoe ea Maemo, le 20 µL ea Tharollo ea Tharollo ho poleiti e tšesaane ea chromatographic (bona Chromatography621) e koahetsoeng ka lera la 0.25-mm ea motsoako oa silika oa chromatographic.Theha chromatogram tsamaisong ea solvent e nang le motsoako oa chloroform, ethyl acetate, methanol, le ammonium hydroxide (90:50:40:1) ho fihlela karolo e ka pele ea solvent e sisinyehile hoo e ka bang karolo ea boraro-nneng ea bolelele ba poleiti.Tlosa poleiti ka kamoreng, tšoaea karolo e ka pele ea solvent, 'me u lumelle solvent hore e fetohe mouoane.Hlahloba poleiti ka tlas'a lebone la UV le lekhutšoane la maqhubu: ho fumanoa qeto e felletseng ea likarolo tse tharo tsa sebaka sa tharollo ea Qeto.Bapisa matla a matheba afe kapa afe a bobeli a bonoang ho chromatogram ea Tharollo ea Teko le a matheba a mantlha ho li-chromatogram tsa tharollo ea Standard: sebaka sefe kapa sefe sa bobeli ho tsoa ho chromatogram ea Tharollo ea Teko e nang le boleng ba RF bo tsamaellanang le bo phahameng ka ho fetesisa. sebaka sa tharollo ea Qeto ha se seholo kapa se matla ho feta sebaka se ka sehloohong se fumanoeng ho Standard solution A (0.4%);'me ha ho sebaka se seng sa bobeli se tsoang ho chromatogram ea Tharollo ea Tlhahlobo se seholo kapa se matla ho feta sebaka se ka sehloohong se fumanoeng ho tsoa ho Standard solution B (0.2%).

mokhoa ii-

Mohato oa mobile le sistimi ea Chromatographic-Tsoela pele joalo ka ha ho laetsoe ho Assay.

Tharollo e tloahelehileng-Tsoela pele joalo ka ha ho laetsoe bakeng sa boitokiso bo tloaelehileng ho Assay.

Tharollo ea teko-Sebelisa ho lokisetsa Assay.

Ts'ebetso-Ka karohano kenya meqolo e lekanang (hoo e ka bang 10 µL) ea tharollo e tloaelehileng le tharollo ea Teko ka har'a chromatograph, rekota li-chromatogram, 'me u lekanye likarabelo tse phahameng.Bala liperesente tsa ho se hloeke ka 'ngoe karolong ea Ondansetron Hydrochloride e nkiloeng ka foromo:

50,000(C/W)(1/F)(ri / rS)
moo C e leng mahloriso, ka mg ka mL, ea USP Ondansetron Hydrochloride RS ka tharollo ea Standard;W ke boima, ka mg, ea Ondansetron Hydrochloride e nkiloeng ho lokisetsa tharollo ea Tlhahlobo;F ke ntlha e lekanyelitsoeng ea karabelo ea litšila joalo ka ha e hlalositsoe tafoleng e tsamaeang;ri ke sebaka se phahameng sa ho se hloeke ka seng ho Tharollo ea Tlhahlobo;'me rS ke sebaka se phahameng sa ondansetron se fumanoang ho tsoa ho Standard solution: e finyella litlhoko tse fanoeng tafoleng e tsamaeang le sehlooho sena.

Lebitso la Motsoako	Nako ea ho Boloka Nako	Leloko Karabo Ntlha	Moeli (%)
Motsoako o amanang le Ondansetron C	hoo e ka bang 0.32	1.2	0.2
Motsoako o amanang le Ondansetron D*	hoo e ka bang 0.34	-	0.1
Imidazole	hoo e ka bang 0.49	0.3	0.2
2-methylimidazole	hoo e ka bang 0.54	0.4	0.2
Ondansetron	1.0	-	-
Motsoako o amanang le Ondansetron A	hoo e ka bang 1.10	0.8	0.2
Tse sa tsejoeng	-	1.0	0.1
Kakaretso	-	-	0.5
* E netefalitsoe tekong ea Limit ea motsoako o amanang le ondansetron D.

Tlhahlobo-

Mobile phase-Lokisetsa motsoako o tlhotliloeng le o senyehileng oa 0.02 M monobasic sodium phosphate (e neng e fetotsoe pele ka 1 M sodium hydroxide ho pH ea 5.4) le acetonitrile (50:50).Etsa litokiso ha ho hlokahala (sheba Tšebeliso ea Sistimi tlas'a Chromatography <621>).

Tlhophiso e tloaelehileng-Hlakola palo e lekantsoeng e nepahetseng ea USP Ondansetron Hydrochloride RS ho Mobile phase, 'me u hlapolle ka bongata, le ka mohato ka mohato ha ho hlokahala, ka Mobile phase ho fumana tharollo e nang le khokahanyo e tsebahalang ea hoo e ka bang 90 µg ka mL.

Tharollo ea ts'ebetso ea Sistimi-Hlakola palo e loketseng ea USP Ondansetron Hydrochloride RS le USP Ondansetron Related Compound A RS in Mobile phase, 'me u hlapolle ka bongata,' me ha ho hlokahala, ka Mobile phase ho fumana tharollo e nang le hoo e ka bang 90 µg ka mL le 20 µg ka mL. , ka ho latellana.

Ho lokisetsa tlhahlobo-Fetisetsa hoo e ka bang 45 mg ea Ondansetron Hydrochloride, e lekantsoeng ka nepo, ho botlolo ea volumetric ea 50-mL, qhibiliha le ho hlapolla ka Mobile phase ho ea bophahamong, le ho kopanya.Pipet 5.0 mL ea tharollo ena ka har'a botlolo ea volumetric ea 50-mL, hlapolla ka karolo ea Mobile ho ea bophahamong, 'me u kopanye.

Chromatographic system (bona Chromatography <621>) -Mokelikeli oa chromatograph o na le mochine oa 216-nm le kholomo ea 4.6-mm × 25-cm e nang le packing L10.Sekhahla sa phallo ke hoo e ka bang 1.5 mL ka motsotso.Chromatograph the System suitability solution, 'me u tlalehe likarabo tsa tlhōrō joalokaha li laetsoe bakeng sa Tsamaiso: linako tse amanang le ho boloka li ka bang 1.0 bakeng sa ondansetron le 1.1 bakeng sa motsoako o amanang le ondansetron A;mme qeto, R, pakeng tsa motsoako o amanang le ondansetron A le ondansetron ha o ka tlase ho 1.5.Chromatograph ea Boitokisetso ba Maemo, 'me u tlalehe likarabelo tse phahameng joalo ka ha li laetsoe bakeng sa Tsamaiso: ntlha ea mohatla ha e fete 2.0;'me kheloha e lekanyelitsoeng bakeng sa liente tse ikatisang ha e fete 1.5%.

Ts'ebetso-Ka karohano kenya li-volume tse lekanang (tse ka bang 10 µL) tsa tokisetso e tloaelehileng le boitokisetso ba Assay ho chromatograph, rekota li-chromatogram, 'me u lekanye likarabo tsa litlhoro tse kholo.Bala palo, ka mg, ea C18H19N3O·HCl karolong ea Ondansetron Hydrochloride e nkiloeng ho latela foromo:

500C(rU / rS)
moo C e leng mahloriso, ka mg ka mL, ea USP Ondansetron Hydrochloride RS ho lokisetsa Standard;'me rU le rS ke libaka tsa tlhoro tse fumanoeng ho tsoa ho Tokisetso ea Assay le Tokiso ea Maemo, ka ho latellana.

103639-04-9 - Mokhoa oa Tlhahiso:

Mokhoa oa 1: Ka mor'a karabelo ea 2-Bromoaniline le1,3-Cyclohexanedione, motsoako oa tetrahydrocarbazole o thehoa, 'me motsoako (III) o fumanoa ka ho itšoara ka dimethylamine le diformaldehyde, le ho hlahisa dimethylaminomethyl sebakeng sa 2.3.80G ea motsoako (III) e ile ea itšoara ka methyl iodide ho fana ka 5.72g ea motsoako (IV) ka ho arola sehlopha sa amino sa mahlakoreng ha se ntse se hlahisa sehlopha sa methyl sebakeng sa 9. 2.0g ea motsoako (IV) le 2-methyl-1h. -imidazole e ile ea itšoara ka dimethylformamide ka ho susumetsa ka 95 ℃.Ho fumana 0.60G ea Ondansetron.

Mokhoa oa 2: Boitšoaro ba cyclohexanone le phenylhydrazine bo fane ka tetrahydrocarbazole ka lihlahisoa tsa 85%.Qhala ka tetrahydrofuran le metsi, eketsa 2,3 Dropwise ho 0 °c ka nitrogen, Tharollo ea 5, 6-tetrachloro-1,4-benzoquinone ka tetrahydrofuran e ile ea tsosoa ho fana ka sehlahisoa sa oxidation (II) ka 67.4% chai.Compound (II), ethanol, concentrated hydrochloric acid, paraformaldehyde le dimethylamine hydrochloride li ile tsa kopanngoa hammoho.Ka mor'a phekolo, sehlahisoa (V) se ile sa fumanoa ka ho eketsa concentrated hydrochloric acid ho acetone le ho sisinyeha ho 50 ℃.Ka tlhahiso ea 71.7%.Motsoako (V) le 2-methylimidazole li ile tsa tšoaroa ka metsing ka 110 ℃.Ho fumana motsoako (VI) ka lihlahisoa tsa 70.9%.Motsoako (VI), methyl iodide le potassium carbonate li ile tsa tsosoa ka mocheso oa kamore ho fihlela tse tiileng li nyamela.E ne e tšeloa ka metsing, e tsosoa, e tlhotliloeng, e hlatsuoa ka metsi, 'me e tsosolositsoe ho tloha methanol ho fumana ondansetron ka lihlahisoa tsa 57.2%.E qhale ka motsoako oa acetone le metsi, Ka ho eketsa concentrated hydrochloric acid ho karabelo, ondansetron hydrochloride dihydrate e fumanoe ka lihlahisoa tsa 92.6%.

Mokhoa oa 3: motsoako (II), potassium carbonate, acetone le dimethyl sulfate li ile tsa tsosoa mocheso oa kamore.Motsoako (VII) o fumanoe ka lihlahisoa tsa 91%.Motsoako (VII) o ile oa qhibiliha ka ethanol 'me motsoako oa paraformaldehyde ea motho le dimethylamine hydrochloride e ile ea kenngoa likarolong tse tlas'a reflux.Refluxing.Ka mor'a phekolo, motsoako (VIII) o ile oa fumanoa ka lihlahisoa tsa 67%.(Viii) e qhibilihisitsoeng ka ethanol ea anhydrous, khase ea hydrogen chloride, hydrochloride ea eona.Hydrochloride e ile ea kenngoa metsing 'me 2 ea eketsoa ka 50 ℃.Methylimidazole, refluxing ondansetron, e fana ka 70%.E ile ea qhibiliha ka isopropanol, metsi le concentrated hydrochloric acid, 'me e tsosoa mocheso oa kamore ho fumana ondansetron hydrochloride dihydrate ka lihlahisoa tsa 90.5%.