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

Apejuwe kukuru:

Orukọ Kemikali: Ondansetron Hydrochloride Dihydrate

CAS: 103639-04-9

Ayẹwo: 98.0 ~ 102.0% (Ṣiṣiro lori ipilẹ anhydrous)

Irisi: Funfun tabi Paa-White Crystalline Powder

Serotonin kan pato (5-HT3) Olugba olugba.Antiemetic

Olubasọrọ: Dokita Alvin Huang

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E-Mail: alvin@ruifuchem.com

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Apejuwe:

Shanghai Ruifu Kemikali jẹ asiwaju olupese ti Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) pẹlu didara to gaju.Ruifu le pese ifijiṣẹ agbaye, idiyele ifigagbaga, iṣẹ ti o dara julọ, kekere ati titobi nla ti o wa.Ra Ondansetron Hydrochloride Dihydrate,Please contact: alvin@ruifuchem.com

Jẹmọ Intermediates:

Awọn agbedemeji ti o jọmọ ti Ondansetron Hydrochloride Dihydrate

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

Kemikali Properties:

Orukọ Kemikali	Ondansetron Hydrochloride Dihydrate
Awọn itumọ ọrọ sisọ	Ondansetron HCl Dihydrate;1,2,3,9-Tetrahydro-9-Methyl-3-[(2-Methyl-1H-imidazol-1-yl) methyl] -4H-Carbazol-4-ọkan Hydrochloride Dihydrate;Emeset;GR 38032 Hydrochloride Dihydrate;SN 307 Hydrochloride Dihydrate;GR 3832 HCl 2H2O;SN-37 HCl 2H2O;NSC665799 HCl 2H2O
Iṣura Ipo	Ninu Iṣura, Iwọn Iṣowo
Nọmba CAS	103639-04-9 (Dihydrate)
Jẹmọ CAS RN	99614-02-5 (Ipilẹ) & 99614-01-4 (Anhydrous)
Fọọmu Molecular	C18H19N3O·HCl · 2H2O
Òṣuwọn Molikula	365,86 g / mol
Ojuami Iyo	176.0 si 180.0 ℃
Ni imọlara	Ooru kókó
Omi Solubility	Tiotuka ninu Omi (> 5 mg / milimita)
Ibi ipamọ otutu.	Itura & Ibi Gbẹ (2 ~ 8℃)
COA & MSDS	Wa
Brand	Ruifu Kemikali

Awọn pato:

Awọn nkan	Ayewo Standards	Esi
Ifarahan	Funfun lati Pa-White Crystalline Powder	Ibamu
Idanimọ
1. UV	O pọju 209, 248, 267, 310nm	Ti o peye
2. IR julọ.Oniranran	Ni ibamu si Eto	Ti o peye
3. Iyatọ ti kiloraidi	Idahun Siwaju	Ti o peye
Omi nipa Karl Fischer	9.0 ~ 10.5%	9.7%
Aloku lori Iginisonu	≤0.10%	0.03%
Awọn Irin Eru (Pb)	≤10ppm	<10ppm
Ondansetron Jẹmọ Agbo C	≤0.20%	0.09%
Ondansetron Jẹmọ agbo D	≤0.10%	0.04%
Imidazole	≤0.20%	0.02%
2-Methylimidazole	≤0.20%	0.02%
Ondansetron Jẹmọ Agbo A	≤0.20%	0.05%
Miiran Unknown Single aimọ	≤0.10%	0.07%
Lapapọ Awọn Aimọ	≤0.50%	0.29%
Aloku ti o ku
Ethanol	≤5000ppm	240ppm
Ayẹwo	98.0 ~ 102.0% (Iṣiro lori ipilẹ anhydrous)	99.81%
Ipari	Ọja naa ti ni idanwo & ni ibamu pẹlu awọn pato

Package/Ipamọ/Gbigbe:

Apo:Igo, apo apamọwọ Aluminiomu, 25kg / Paali Drum, tabi gẹgẹbi ibeere alabara.
Ipò Ìpamọ́:Tọju ni wiwọ titi eiyan.Fipamọ sinu itura, gbigbẹ (2 ~ 8℃) ati ile-itaja ti o ni afẹfẹ daradara kuro ninu awọn nkan ti ko ni ibamu.Dabobo lati ina ati ọrinrin.
Gbigbe:Firanṣẹ si agbaye nipasẹ afẹfẹ, nipasẹ FedEx / DHL Express.Pese ifijiṣẹ yarayara ati igbẹkẹle.

Awọn anfani:

Agbara to to: Awọn ohun elo to ati awọn onimọ-ẹrọ

Iṣẹ Ọjọgbọn: Iṣẹ rira iduro kan

OEM Package: Aṣa package ati aami wa

Ifijiṣẹ Yara: Ti o ba wa laarin ọja iṣura, iṣeduro ifijiṣẹ ọjọ mẹta

Ipese Idurosinsin: Ṣetọju ọja iṣura ti o tọ

Atilẹyin imọ-ẹrọ: Ojutu imọ-ẹrọ wa

Iṣẹ Iṣọkan Aṣa: Larin lati giramu si kilos

Didara to gaju: Ṣeto eto idaniloju didara pipe

FAQ:

Bawo ni lati Ra?Jọwọ kan siDr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com

15 Ọdun Iriri?A ni diẹ sii ju ọdun 15 ti iriri ni iṣelọpọ ati okeere ti ọpọlọpọ awọn agbedemeji elegbogi didara tabi awọn kemikali to dara.

Awọn ọja akọkọ?Ta si ọja ile, North America, Europe, India, Korea, Japanese, Australia, ati be be lo.

Awọn anfani?Didara to gaju, idiyele ifarada, awọn iṣẹ alamọdaju ati atilẹyin imọ-ẹrọ, ifijiṣẹ yarayara.

DidaraIdaniloju?Eto iṣakoso didara to muna.Awọn ohun elo ọjọgbọn fun itupalẹ pẹlu NMR, LC-MS, GC, HPLC, ICP-MS, UV, IR, OR, KF, ROI, LOD, MP, Clarity, Solubility, Microbial limit test, bbl

Awọn apẹẹrẹ?Pupọ awọn ọja pese awọn apẹẹrẹ ọfẹ fun igbelewọn didara, idiyele gbigbe yẹ ki o san nipasẹ awọn alabara.

Ayẹwo ile-iṣẹ?Ayẹwo ile-iṣẹ kaabo.Jọwọ ṣe ipinnu lati pade ni ilosiwaju.

MOQ?Ko si MOQ.Ibere kekere jẹ itẹwọgba.

Akoko Ifijiṣẹ? Ti o ba wa laarin ọja iṣura, iṣeduro ifijiṣẹ ọjọ mẹta.

Gbigbe?Nipa Express (FedEx, DHL), nipasẹ Air, nipasẹ Okun.

Awọn iwe aṣẹ?Lẹhin iṣẹ tita: COA, MOA, ROS, MSDS, ati bẹbẹ lọ ni a le pese.

Aṣa Synthesis?Le pese awọn iṣẹ iṣelọpọ aṣa lati baamu awọn iwulo iwadii rẹ dara julọ.

Awọn ofin sisan?Iwe risiti Proforma yoo firanṣẹ ni akọkọ lẹhin ijẹrisi aṣẹ, ti ifi alaye banki wa sinu.Isanwo nipasẹ T/T (Telex Gbigbe), PayPal, Western Union, ati bẹbẹ lọ.

103639-04-9 - Ewu ati Aabo:

Awọn koodu ewu
R25 - Majele ti o ba gbe
R36 / 37/38 - Irritating si oju, eto atẹgun ati awọ ara.
Apejuwe Abo
S45 - Ni ọran ti ijamba tabi ti o ba ni ailara, wa imọran iṣoogun lẹsẹkẹsẹ (fi aami han nigbakugba ti o ṣee ṣe.)
S37/39 - Wọ awọn ibọwọ ti o dara ati aabo oju / oju
S26 - Ni ọran ti olubasọrọ pẹlu awọn oju, fi omi ṣan lẹsẹkẹsẹ pẹlu ọpọlọpọ omi ki o wa imọran iṣoogun.
UN ID UN 2811 6.1/PG 3
WGK Germany 3
RTECS FE6375500
HS koodu 29339900
Ewu Kilasi 6.1(a)
Iṣakojọpọ Ẹgbẹ II

103639-04-9 - Ohun elo:

Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) jẹ antagonist olugba olugba kan pato ti serotonin (5-HT3).Antiemetic.Ondansetron Hydrochloride Dihydrate ni a lo lati ṣe idiwọ ríru ati eebi ti o le fa nipasẹ iṣẹ abẹ, kimoterapi akàn, tabi itọju itankalẹ.Awọn antagonists olugba 5-HT3 ni Ondansetron jẹ awọn oogun akọkọ ti a lo lati ṣe itọju ati dena ọgbun ati eebi ti o fa chemotherapy ati ọgbun ati eebi ti o fa radiotherapy, nipasẹ didi awọn iṣe ti awọn kemikali ninu ara.Ipa naa dara ju metoclopramide lọ lakoko ti o kere ju cyclizine tabi droperidol.Sibẹsibẹ, o ni ipa diẹ lori eebi ti o ṣẹlẹ nipasẹ aisan išipopada.O le jẹ fifun nipasẹ ẹnu, nipasẹ abẹrẹ sinu iṣan tabi sinu iṣọn.

Ondansetron ati Granisetron, Dolasetron jẹ awọn antiemetics mẹta ti o wọpọ ni ile-iwosan ti a lo, ondansetron jẹ oludena olugba serotonin ti o munadoko (5-HT3) eyiti o jẹ iyipada ati yiyan, fun α1, α2, β1, β2-adrenergic awọn olugba ati histamine H1, awọn olugba H2, it ni ipa ti o kere ju, fun awọn olugba H, aarin ati awọn olugba dopaminergic agbeegbe, ko ni ipa atako, o le dinku kimoterapi ati ọgbun ati eebi ti radiotherapy.Ti a ṣe afiwe pẹlu metoclopramide, ipa antiemetic rẹ lagbara ati pe ko ni awọn aati extrapyramidal.Fun eebi ti o fa nipasẹ cisplatin, cyclophosphamide, doxorubicin, ati bẹbẹ lọ o le ṣe agbejade ipa antiemetic iyara ati lagbara.O dara kii ṣe fun itọju ríru ati eebi nikan ti o ṣẹlẹ nipasẹ chemotherapy cytotoxic ati itọju ailera itankalẹ, ṣugbọn tun fun idena ati itọju ọgbun ati eebi ti o fa nipasẹ awọn iṣẹ abẹ.Ondansetron ṣiṣẹ bi aaye gbigbe laarin visceral afferent nafu ti a mu ṣiṣẹ ni inu ikun ikun ati ile-iṣẹ eebi laarin ọpa ẹhin , eyiti o yori si diaphragm ati awọn iṣan iṣan inu.Kimoterapi ati Ìtọjú ailera le fa oporoku 5-HT itusilẹ ati ki o fa vagus nafu fọwọkan nipa 5-HT3 olugba, eyi ti o fa ìgbagbogbo reflex.Ọja yii ṣe idiwọ ifasilẹ yii ti n ṣẹlẹ, ni akoko kanna o ṣe idiwọ eebi ti o fa nipasẹ iṣe aarin.Ilana nipa ríru ati eebi lẹhin iṣẹ abẹ jẹ aimọ.Ondansetron ni apapo pẹlu dexamethasonecan le mu ipa anti-emetic pọ si.

103639-04-9 - Awọn ipa ẹgbẹ:

Eyi fa itusilẹ afferent vagal, ti nfa eebi.Ni abuda si awọn olugba 5-HT3, ondansetron ṣe idiwọ itọsi serotonin, nitorinaa ìgbagbogbo, lẹhin awọn iwuri emetogenic gẹgẹbi cisplatin.Orififo jẹ ipa buburu ti a royin nigbagbogbo ti awọn oogun wọnyi.

103639-04-9 - Profaili Aabo:

A majele nipa iṣan ipa.Human systemic ipa nipasẹ iṣan ipa ọna: jaundice.Nigbati o ba gbona si jijẹ, o njade awọn vapors majele ti NOx.

103639-04-9 - Awọn oogun ati awọn itọju ti ogbo:

Ti a lo bi antiemetic nigbati awọn antiemetics ti aṣa ko ni doko, gẹgẹbi nigbati o nṣakoso cisplatin tabi fun awọn idi miiran ti eebi ti ko le fa.Lilo ondansetron ninu awọn ologbo jẹ ariyanjiyan diẹ ati diẹ ninu awọn ipinlẹ ko yẹ ki o lo ninu eya yii.

Awọn ibaraẹnisọrọ oogun O pọju awọn ibaraenisepo eewu pẹlu awọn oogun miiran.

103639-04-9 - USP35 Standard:

Ondansetron Hydrochloride ni ko kere ju 98.0 ogorun ati pe ko ju 102.0 ogorun ti C18H19N3O·HCl, ṣe iṣiro lori ipilẹ anhydrous.

Iṣakojọpọ ati ibi ipamọ-Fipamọ sinu wiwọ, awọn apoti sooro ina.Tọju ni 25

, inọju idasilẹ laarin 15

ati 30

Awọn ajohunše Itọkasi USP <11>-

USP Ondansetron Hydrochloride RS

USP Ondansetron Jẹmọ Agbo A RS

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

USP Ondansetron Resolution Adalu RS

Ondansetron hydrochloride nini to 0.4% w/w ti awọn mejeeji ondansetron jẹmọ yellow A ati 6,6¢-methylene bis-[(1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-) imidazol-1-yl)-methyl]-4H-carbazol-4-ọkan)]

USP Ondansetron Jẹmọ Agbo C RS
1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-ọkan.

USP Ondansetron Jẹmọ Agbo D RS
1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-ọkan.

Idanimọ-

A: Gbigba infurarẹẹdi <197M>.

B: Tu 20 miligiramu ni 2 mL ti omi, fi 1 milimita ti 2 M nitric acid, ati àlẹmọ: filtrate ṣe idahun si idanwo fun Chloride <191>.

Omi, Ọna Ia <921>: laarin 9.0% ati 10.5%.

Aloku lori ina <281>: ko ju 0.1%.

Ifilelẹ ti ondansetron ti o ni ibatan agbo D-

Alagbeka alakoso- Mura idapọ ti a ti yo ati degassed ti 0.02 M monobasic potasiomu fosifeti (ṣatunṣe tẹlẹ pẹlu 1 M sodium hydroxide si pH ti 5.4) ati acetonitrile (80:20).Ṣe awọn atunṣe ti o ba jẹ dandan (wo Ibaramu Eto labẹ Chromatography <621>).

Ojutu boṣewa-Tu ohun elo ti o ni iwọn deede ti USP Ondansetron Jẹmọ Compound D RS ni apakan Alagbeka, ki o dilute ni iwọn, ati ni igbese-igbesẹ ti o ba jẹ dandan, pẹlu alakoso Alagbeka lati gba ojutu kan ti o ni ifọkansi ti a mọ ti nipa 0.4 µg fun milimita.

Ojutu ìbójúmu eto-Tu awọn iwọn to dara ti USP Ondansetron Jẹmọ Compound D RS ati USP Ondansetron Jẹmọ Compound C RS ni apakan Alagbeka, ati dilute ni iwọn, ati ni igbesẹ ti o ba jẹ dandan, pẹlu apakan Alagbeka lati gba ojutu kan ti o ni ifọkansi ti 0.6 µg fun milimita kan ati 1 µg fun milimita kan, lẹsẹsẹ.

Ojutu idanwo-Gbigbe lọ si iwọn 50 miligiramu ti Ondansetron Hydrochloride, ni iwọn deede, si ọpọn iwọn didun 100-mL, tu sinu ati dilute pẹlu apakan Alagbeka si iwọn didun, ati dapọ.

Eto Chromatographic (wo Chromatography <621>) -Kromatograph olomi ti ni ipese pẹlu aṣawari 328-nm ati iwe 4.6-mm × 25-cm ti o ni iṣakojọpọ L10.Iwọn sisan jẹ nipa 1.5 milimita fun iṣẹju kan.Chromatograph ojutu ibaramu Eto, ati ṣe igbasilẹ awọn idahun ti o ga julọ bi a ti ṣe itọsọna fun Ilana: awọn akoko idaduro ibatan jẹ nipa 0.8 fun ondansetron ti o ni ibatan agbo C ati 1.0 fun ondansetron ti o ni ibatan D;ati ipinnu, R, laarin ondansetron ti o ni ibatan yellow C ati ondansetron ti o ni ibatan yellow D ko din ju 1.5.Chromatograph the Standard ojutu, ati ki o ṣe igbasilẹ awọn idahun ti o ga julọ bi a ti ṣe itọsọna fun Ilana: ṣiṣe ti ọwọn ti a pinnu lati tente oke atupale ko din ju 400 awọn abọ imọ-jinlẹ;ati iyapa boṣewa ojulumo fun awọn abẹrẹ ẹda ko ju 2.0%.

Ilana- Lọtọ ara awọn iwọn didun dogba (nipa 20 µL) ti ojutu Standard ati ojutu Idanwo sinu chromatograph, ṣe igbasilẹ awọn chromatogram, ati wiwọn awọn idahun fun awọn oke pataki.Ṣe iṣiro ipin ipin ti ondansetron ti o ni ibatan D ni apakan ti Ondansetron Hydrochloride ti o mu nipasẹ agbekalẹ:

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

ninu eyiti C jẹ ifọkansi, ni mg fun milimita kan, ti USP Ondansetron Related Compound D RS ni ojutu Standard;W jẹ iwuwo, ni mg, ti Ondansetron Hydrochloride ti a mu lati ṣeto ojutu Idanwo;ati rU ati rS jẹ awọn agbegbe ti o ga julọ ti a gba lati ojutu Idanwo ati ojutu Standard, lẹsẹsẹ: ko ju 0.10% ti a rii.

Kromatographic mimọ-

ọna i-

Ojutu ipinnu-tu opoiye ti USP Ondansetron Resolution Mixture RS ni kẹmika kẹmika, ki o dilute ni iwọn, ati ni igbese-igbesẹ ti o ba jẹ dandan, pẹlu methanol lati gba ojutu ti o ni ifọkansi ti a mọ ti 12.5 mg fun miligiramu.

Awọn ojutu boṣewa-Tu iwọn wiwọn deede ti USP Ondansetron Hydrochloride RS ninu kẹmika kẹmika, ati dapọ lati gba ojutu kan ti o ni ifọkansi ti a mọ ti bii 0.25 mg fun miligiramu.Ni iwọntunwọnsi di ojutu yii pẹlu kẹmika lati gba awọn solusan Standard, ti a yan ni isalẹ nipasẹ lẹta, nini awọn akopọ wọnyi:

Standard ojutu	Dilution	Ifojusi (µg RS fun milimita)	Ogorun (%, fun lafiwe pẹlu apẹrẹ idanwo)
A	(1 ninu 5)	50	0.4
B	(1 ninu 10)	25	0.2
C	(1 ninu 20)	12.5	0.1

Ojutu idanwo-Tu iwọnwọnwọn deede ti Ondansetron Hydrochloride ni kẹmika kẹmika lati gba ojutu kan ti o ni 12.5 mg fun milimita kan.Ilana- Lọtọ lo 20 µL ti ojutu Idanwo, 20 µL ti ojutu Standard kọọkan, ati 20 µL ti ojutu Ipinnu si awo chromatographic tinrin-Layer (wo Chromatography621) ti a bo pelu 0.25-mm Layer ti chromatographic silica gel mix.Dagbasoke chromatogram ni eto olomi ti o ni idapọ chloroform, ethyl acetate, kẹmika kẹmika, ati ammonium hydroxide (90:50:40:1) titi ti iwaju olomi yoo ti gbe bii idamẹta ninu mẹrin ti ipari awo naa.Yọ awo kuro ninu iyẹwu naa, samisi iwaju epo, ki o jẹ ki epo naa yọ kuro.Ṣayẹwo awo naa labẹ ina UV gigun-kukuru: ipinnu pipe ti awọn paati mẹta ti aaye ojutu ipinnu ni a rii.Ṣe afiwe awọn kikankikan ti eyikeyi awọn aaye Atẹle ti a ṣe akiyesi ni chromatogram ti ojutu Idanwo pẹlu awọn ti awọn aaye akọkọ ninu awọn chromatograms ti awọn ojutu Standard: eyikeyi aaye keji lati chromatogram ti ojutu Idanwo ti o ni iye RF ti o baamu ti ti ile-ẹkọ giga ti o ga julọ iranran ti ojutu Ipinnu ko tobi tabi diẹ sii lile ju aaye akọkọ ti a gba lati ojutu Standard A (0.4%);ati pe ko si aaye keji miiran lati chromatogram ti ojutu Idanwo ti o tobi tabi diẹ sii ju aaye akọkọ ti a gba lati ojutu Standard B (0.2%).

ọna ii-

Abala alagbeka ati eto Chromatographic-Tẹsiwaju bi a ti ṣe itọsọna ninu Assay.

Ojutu boṣewa-Tẹsiwaju bi a ti ṣe itọsọna fun igbaradi Standard ni Assay.

Idanwo ojutu-Lo Assay igbaradi.

Ilana-Lọtọ ara awọn iwọn didun dogba (bii 10 µL) ti ojutu Standard ati ojutu Idanwo sinu chromatograph, ṣe igbasilẹ awọn chromatogram, ati wiwọn awọn idahun ti o ga julọ.Ṣe iṣiro ipin ogorun aimọ kọọkan ni apakan Ondansetron Hydrochloride ti o mu nipasẹ agbekalẹ:

50,000(C/W)(1/F)(ri / rS)
ninu eyiti C jẹ ifọkansi, ni miligiramu fun milimita kan, ti USP Ondansetron Hydrochloride RS ni ojutu Standard;W jẹ iwuwo, ni mg, ti Ondansetron Hydrochloride ti a mu lati ṣeto ojutu Idanwo;F jẹ ifosiwewe idahun ojulumo ti awọn aimọ bi a ti ṣalaye ninu tabili ti o tẹle;ri jẹ agbegbe ti o ga julọ fun aimọ kọọkan ninu ojutu Idanwo;ati rS jẹ agbegbe ti o ga julọ ti ondansetron ti a gba lati inu ojutu Standard: o pade awọn ibeere ti a fun ni tabili ti o tẹle.

Orukọ Apapo	Ojulumo Idaduro Time	Ojulumo Idahun Okunfa	Idiwọn (%)
Ondansetron ti o ni ibatan C	nipa 0.32	1.2	0.2
Ondansetron ti o ni ibatan D*	nipa 0.34	-	0.1
Imidazole	nipa 0,49	0.3	0.2
2-methylimidazole	nipa 0,54	0.4	0.2
Ondansetron	1.0	-	-
Ondansetron ti o ni ibatan A	nipa 1.10	0.8	0.2
Aimọ	-	1.0	0.1
Lapapọ	-	-	0.5
* Ti ṣe iwọn ninu idanwo fun Idiwọn ti ondansetron ti o ni ibatan D.

Ayẹwo-

Alagbeka alakoso-Mura idapọ ti a ti yo ati degassed ti 0.02 M monobasic sodium fosifeti (atunse tẹlẹ pẹlu 1 M sodium hydroxide si pH ti 5.4) ati acetonitrile (50:50).Ṣe awọn atunṣe ti o ba jẹ dandan (wo Ibaramu Eto labẹ Chromatography <621>).

Igbaradi Boṣewa-Tu opoiye iwuwo deede ti USP Ondansetron Hydrochloride RS ni apakan Alagbeka, ki o dilute ni iwọn, ati ni igbese-igbesẹ ti o ba jẹ dandan, pẹlu alakoso Alagbeka lati gba ojutu kan ti o ni ifọkansi ti a mọ ti bii 90 µg fun milimita.

Ojutu ibaamu eto-tu awọn iwọn to dara ti USP Ondansetron Hydrochloride RS ati USP Ondansetron Jẹmọ Compound A RS ni apakan Alagbeka, ati dilute ni iwọn, ati ni igbesẹ ti o ba jẹ dandan, pẹlu apakan Alagbeka lati gba ojutu kan ti o ni nipa 90 μg fun milimita ati 20 µg fun milimita kan , lẹsẹsẹ.

Igbaradi Assay-Gbigbe lọ si iwọn 45 miligiramu ti Ondansetron Hydrochloride, ni iwọn deede, si ọpọn iwọn didun 50-mL, tu sinu ati dilute pẹlu apakan Alagbeka si iwọn didun, ati dapọ.Pipet 5.0 milimita ti ojutu yii sinu ọpọn iwọn didun 50-mL, dilute pẹlu apakan Alagbeka si iwọn didun, ati dapọ.

Eto Chromatographic (wo Chromatography <621>) -Kromatograph olomi ti ni ipese pẹlu aṣawari 216-nm ati iwe 4.6-mm × 25-cm ti o ni iṣakojọpọ L10.Iwọn sisan jẹ nipa 1.5 milimita fun iṣẹju kan.Chromatograph ojutu ibaamu eto, ati ṣe igbasilẹ awọn idahun ti o ga julọ bi a ti ṣe itọsọna fun Ilana: awọn akoko idaduro ibatan jẹ nipa 1.0 fun ondansetron ati 1.1 fun agbo ti o ni ibatan ondansetron;ati ipinnu, R, laarin ondansetron jẹmọ yellow A ati ondansetron ko kere ju 1.5.Chromatograph the Standard igbaradi, ati ki o gbasilẹ awọn idahun ti o ga julọ bi a ti ṣe itọsọna fun Ilana: ifosiwewe iru ko ju 2.0 lọ;ati iyapa boṣewa ibatan fun awọn abẹrẹ ẹda ko ju 1.5%.

Ilana-Lọtọ ara awọn iwọn didun dogba (bii 10 µL) ti igbaradi Standard ati igbaradi Assay sinu chromatograph, ṣe igbasilẹ awọn chromatogram, ati wiwọn awọn idahun fun awọn oke pataki.Ṣe iṣiro iye, ni mg, ti C18H19N3O·HCl ni ipin Ondansetron Hydrochloride ti o mu nipasẹ agbekalẹ:

500C(rU/rS)
ninu eyiti C jẹ ifọkansi, ni miligiramu fun milimita kan, ti USP Ondansetron Hydrochloride RS ni igbaradi Standard;ati rU ati rS jẹ awọn agbegbe ti o ga julọ ti a gba lati igbaradi Assay ati igbaradi Standard, lẹsẹsẹ.

103639-04-9 - Ọna iṣelọpọ:

Ọna 1: Lẹhin iṣesi ti 2-Bromoaniline ati1,3-Cyclohexanedione, Awọn itọsẹ tetrahydrocarbazole ti wa ni akoso, ati agbo (III) ni a gba nipasẹ didaṣe pẹlu dimethylamine ati diformaldehyde, ati ṣafihan dimethylaminomethyl ni ipo 2.3.80G ti yellow (III) ni a ṣe pẹlu methyl iodide lati fun 5.72g ti yellow (IV) nipasẹ quaternizing ẹgbẹ amino ẹgbẹ nigba ti o ṣafihan ẹgbẹ methyl ni ipo 9. 2.0g ti yellow (IV) ati 2-methyl-1h -imidazole ni a ṣe atunṣe ni dimethylformamide pẹlu gbigbọn ni 95 ℃.Lati gba 0.60G ti Ondansetron.

Ọna 2: Idahun ti cyclohexanone ati phenylhydrazine fun tetrahydrocarbazole ni 85% ikore.Tu ni tetrahydrofuran ati omi, fi 2,3 Dropwise ni 0 °c ni nitrogen, A ojutu ti 5, 6-tetrachloro-1,4-benzoquinone ni tetrahydrofuran ti a ru lati fun ọja oxidation (II) ni 67.4% ikore.Apapo (II), ethanol, hydrochloric acid ogidi, paraformaldehyde ati dimethylamine hydrochloride ni a tun pada papọ.Lẹhin itọju naa, ọja naa (V) ni a gba nipasẹ fifi hydrochloric acid ti o ni idojukọ si acetone ati fifa ni 50℃.Ni 71.7% ikore.Apapo (V) ati 2-methylimidazole ni a ṣe atunṣe ninu omi ni 110 ℃.Lati gba yellow (VI) ni 70.9% ikore.Apapo (VI), methyl iodide ati potasiomu kaboneti ni a ru soke ni iwọn otutu yara titi ti o lagbara ti sọnu.O ti dà sinu omi, ru, filtered, fo pẹlu omi, ati recrystallized lati methanol lati gba ondansetron ni 57.2% ikore.Tu rẹ sinu adalu acetone ati omi, Nipa fifi ogidi hydrochloric acid si iṣesi, ondansetron hydrochloride dihydrate ti gba pẹlu ikore ti 92.6%.

Ọna 3: yellow (II), potasiomu carbonate, acetone ati dimethyl sulfate ni a mu soke ni iwọn otutu yara.Apapo (VII) ni a gba ni ikore ti 91%.Apapo (VII) ni tituka ni ethanol ati adalu paraformaldehyde eniyan ati dimethylamine hydrochloride ni a ṣafikun ni awọn ipin labẹ reflux.Refluxing.Lẹhin itọju, agbo (VIII) ni a gba ni 67% ikore.(Viii) tituka sinu ethanol anhydrous, gaasi hydrogen kiloraidi, hydrochloride rẹ.A ṣafikun hydrochloride si omi ati pe a ṣafikun 2 ni 50℃.Methylimidazole, ondansetron refluxing, ikore 70%.O ti wa ni tituka ni isopropanol, omi ati ogidi hydrochloric acid, ati ki o rú ni yara otutu lati gba ondansetron hydrochloride dihydrate ni kan ikore ti 90.5%.