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

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

Kufotokozera Kwachidule:

Dzina la Mankhwala: Ondansetron Hydrochloride Dihydrate

CAS: 103639-04-9

Kuyesa: 98.0 ~ 102.0% (Yowerengedwa pa maziko a anhydrous)

Maonekedwe: Ufa Woyera Kapena Woyera Wamakristalo

A Specific Serotonin (5-HT3) Receptor Antagonist.Antiemetic

Lumikizanani ndi Dr. Alvin Huang

Mobile/Wechat/WhatsApp: +86-15026746401

E-Mail: alvin@ruifuchem.com

Titumizireni imelo

Tsatanetsatane wa Zamalonda

Zogwirizana nazo

Zolemba Zamalonda

Kufotokozera:

Shanghai Ruifu Chemical ndi omwe amapanga Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) ndi apamwamba kwambiri.Ruifu atha kubweretsa padziko lonse lapansi, mtengo wampikisano, ntchito zabwino kwambiri, zochepa komanso zochulukirapo zomwe zilipo.Gulani Ondansetron Hydrochloride Dihydrate,Please contact: alvin@ruifuchem.com

Ogwirizana Apakati:

Zofananira za Ondansetron Hydrochloride Dihydrate

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

Chemical Properties:

Dzina la Chemical	Ondansetron Hydrochloride Dihydrate
Mawu ofanana ndi mawu	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
Stock Status	Mu Stock, Commercial Scale
Nambala ya CAS	103639-04-9 (Dihydrate)
Zogwirizana ndi CAS RN	99614-02-5 (Base) & 99614-01-4 (Zopanda madzi)
Molecular Formula	C18H19N3O·HCl·2H2O
Kulemera kwa Maselo	365.86 g / mol
Melting Point	176.0 mpaka 180.0 ℃
Zomverera	Kutentha Kwambiri
Kusungunuka kwamadzi	Kusungunuka m'madzi (> 5 mg/ml)
Kusungirako Temp.	Malo Ozizira & Owuma (2~8℃)
COA & MSDS	Likupezeka
Mtundu	Ruifu Chemical

Zofotokozera:

Zinthu	Miyezo Yoyendera	Zotsatira
Maonekedwe	Ufa Wa Crystalline Woyera mpaka Woyera	Zimagwirizana
Chizindikiritso
1. UV	Max 209, 248, 267, 310nm	Woyenerera
2. IR sipekitiramu	Zimagwirizana ndi Kapangidwe	Woyenerera
3. Kusankhana kwa Kloridi	Forward Reaction	Woyenerera
Madzi ndi Karl Fischer	9.0-10.5%	9.7%
Zotsalira pa Ignition	≤0.10%	0.03%
Zitsulo Zolemera (Pb)	≤10ppm	<10ppm
Ondansetron Related Compound C	≤0.20%	0.09%
Ondansetron Related compound D	≤0.10%	0.04%
Imidazole	≤0.20%	0.02%
2-Methylimidazole	≤0.20%	0.02%
Ondansetron Related Compound A	≤0.20%	0.05%
Chidetso China Chosadziwika	≤0.10%	0.07%
Zonse Zonyansa	≤0.50%	0.29%
Zosungunulira Zotsalira
Ethanol	≤5000ppm	240ppm
Kuyesa	98.0 ~ 102.0% (Yowerengedwa pa maziko a anhydrous)	99.81%
Mapeto	Chogulitsacho chayesedwa ndipo chikugwirizana ndi zomwe zanenedwa

Phukusi/kusungirako/Manyamulidwe:

Phukusi:Botolo, Aluminiyamu zojambulazo thumba, 25kg/Cardboard Drum, kapena malinga ndi zofunika kasitomala.
Mkhalidwe Wosungira:Sungani mu chidebe chotsekedwa mwamphamvu.Sungani pamalo ozizira, owuma (2 ~ 8 ℃) komanso molowera mpweya wabwino kutali ndi zinthu zomwe sizingagwirizane.Tetezani ku kuwala ndi chinyezi.
Manyamulidwe:Kutumiza kudziko lonse lapansi ndi ndege, ndi FedEx / DHL Express.Perekani mwamsanga ndi yodalirika yobereka.

Ubwino:

Mphamvu Zokwanira: Malo okwanira ndi akatswiri

Utumiki Waukatswiri: Ntchito imodzi yosiya kugula

Phukusi la OEM: Phukusi lamwambo ndi zolemba zilipo

Kutumiza Mwachangu: Ngati mkati mwa katundu, kuperekedwa kwamasiku atatu kumatsimikizika

Zinthu Zokhazikika: Khalani ndi katundu wokwanira

Thandizo laukadaulo: Yankho laukadaulo likupezeka

Custom Synthesis Service: Kuchokera pa magalamu mpaka ma kilos

Ubwino Wapamwamba: Anakhazikitsa dongosolo lathunthu lotsimikizira zaubwino

FAQ:

Kodi kugula?Chonde lemberaniDr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com

Zaka 15 Zokumana nazo?Tili ndi zaka zopitilira 15 pakupanga ndi kutumiza kunja kwamitundu yambiri yamankhwala apamwamba kwambiri kapena mankhwala abwino.

Misika Yaikulu?Gulitsani kumsika wapakhomo, North America, Europe, India, Korea, Japan, Australia, etc.

Ubwino wake?Ubwino wapamwamba, mtengo wotsika mtengo, ntchito zamaluso ndi chithandizo chaukadaulo, kutumiza mwachangu.

UbwinoChitsimikizo?Njira yoyendetsera bwino kwambiri.Zida zaukadaulo zowunikira zikuphatikizapo NMR, LC-MS, GC, HPLC, ICP-MS, UV, IR, OR, KF, ROI, LOD, MP, Clarity, Solubility, Microbial limit test, etc.

Zitsanzo?Zogulitsa zambiri zimapereka zitsanzo zaulere zowunikira zabwino, mtengo wotumizira uyenera kulipidwa ndi makasitomala.

Factory Audit?Takulandilani ku fakitale.Chonde panganitu nthawi yokumana.

MOQ?Palibe MOQ.Dongosolo laling'ono ndilovomerezeka.

Nthawi yoperekera? Ngati mkati mwa katundu, kubweretsa masiku atatu kutsimikizika.

Mayendedwe?Ndi Express (FedEx, DHL), ndi Air, ndi Nyanja.

Zolemba?Pambuyo pa ntchito yogulitsa: COA, MOA, ROS, MSDS, ndi zina zotero.

Custom Synthesis?Itha kukupatsirani ntchito zophatikizira zomwe zikugwirizana bwino ndi zosowa zanu zofufuza.

Malipiro Terms?Invoice ya Proforma idzatumizidwa kaye mukatsimikizira kuyitanitsa, ndikuyika zambiri zathu zakubanki.Malipiro a T/T (Telex Transfer), PayPal, Western Union, etc.

103639-04-9 - Zowopsa ndi Chitetezo:

Zizindikiro Zowopsa
R25 - Zowopsa ngati zitamezedwa
R36/37/38 - Zokwiyitsa maso, kupuma komanso khungu.
Kufotokozera Zachitetezo
S45 - Pakachitika ngozi kapena ngati simukumva bwino, funsani upangiri wachipatala nthawi yomweyo (onetsani chizindikirocho ngati kuli kotheka.)
S37/39 - Valani magolovesi oyenera komanso chitetezo chamaso / kumaso
S26 - Mukakhudzana ndi maso, muzimutsuka nthawi yomweyo ndi madzi ambiri ndipo funsani malangizo achipatala.
Ma ID a UN UN 2811 6.1/PG 3
WGK Germany 3
Mtengo wa RTECS FE6375500
HS kodi 29339900
Kalasi Yowopsa 6.1(a)
Packing Gulu II

103639-04-9 - Ntchito:

Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) ndi serotonin (5-HT3) receptor antagonist.Antiemetic.Ondansetron Hydrochloride Dihydrate imagwiritsidwa ntchito poletsa nseru ndi kusanza komwe kungayambike chifukwa cha opaleshoni, mankhwala a khansa, kapena chithandizo cha radiation.5-HT3 receptor antagonists ku Ondansetron ndi mankhwala oyambirira omwe amagwiritsidwa ntchito pochiza ndi kuteteza chemotherapy-induced nseru ndi kusanza ndi radiotherapy-induced nseru ndi kusanza, kupyolera mu kutsekereza zochita za mankhwala m'thupi.Mphamvu yake ndi yabwino kuposa metoclopramide pomwe imakhala yochepa kuposa cyclizine kapena droperidol.Komabe, zimakhala ndi zotsatira zochepa pa kusanza koyambitsidwa ndi matenda oyenda.Atha kuperekedwa pakamwa, jekeseni mu minofu kapena mumtsempha.

Ondansetron ndi Granisetron, Dolasetron ndi mankhwala atatu omwe amagwiritsidwa ntchito pachipatala, ondansetron ndi serotonin (5-HT3) receptor blocker yomwe imakhala yosinthika komanso yosankha, ya α1, α2, β1, β2-adrenergic receptors ndi histamine H1, H2 receptors, ali ndi zotsatira zochepa, chifukwa cha H receptors, chapakati ndi zotumphukira dopaminergic zolandilira, alibe zotsatira antagonistic, akhoza kupondereza chemotherapy ndi radiotherapy-induced nseru ndi kusanza.Poyerekeza ndi metoclopramide, mphamvu yake ya antiemetic imakhala yamphamvu ndipo ilibe zochita za extrapyramidal.Pakuti kusanza anachititsa ndi cisplatin, cyclophosphamide, doxorubicin, etc. akhoza kutulutsa mofulumira ndi amphamvu antiemetic kwenikweni.Ndizoyenera osati zochizira nseru ndi kusanza komwe kumayambitsidwa ndi cytotoxic chemotherapy ndi radiation therapy, komanso kupewa ndi kuchiza nseru ndi kusanza komwe kumachitika chifukwa cha maopaleshoni.Ondansetron amagwira ntchito ngati malo odutsa pakati pa mitsempha yotchedwa visceral afferent yomwe imayendetsedwa m'matumbo a m'mimba ndi kusanza mkati mwa msana, zomwe zimatsogolera ku diaphragm ndi minofu ya m'mimba.Chemotherapy ndi radiation therapy ingayambitse matumbo a 5-HT ndikuyambitsa kukondoweza kwa mitsempha ya vagus ndi 5-HT3 receptor, yomwe imayambitsa kusanza kwa reflex.Izi zimalepheretsa kuti reflex izi zichitike, nthawi yomweyo zimatchinga kusanza komwe kumachitika chifukwa chapakati.Njira yokhudzana ndi nseru ndi kusanza pambuyo pa opaleshoni sichidziwika.Ondansetron pamodzi ndi dexamethasonecan amatha kupititsa patsogolo anti-emetic effect.

103639-04-9 - Zotsatira zake:

Izi zimabweretsa kutulutsa kwa vagal, komwe kumayambitsa kusanza.Pomangiriza ku 5-HT3 zolandilira, ondansetron imatchinga kukondoweza kwa serotonin, motero kusanza, pambuyo pa zokopa za emetogenic monga cisplatin.Kupweteka kwamutu ndiko komwe kumanenedwa kawirikawiri zotsatira za mankhwalawa.

103639-04-9 - Mbiri Yachitetezo:

Poyizoni podutsa mtsempha wa mtsempha. Human systemic effects by intravenous route: jaundice.Ikatenthedwa kuti iwonongeke imatulutsa nthunzi wapoizoni waNOx.

103639-04-9 - Mankhwala a Chowona Zanyama ndi Chithandizo:

Amagwiritsidwa ntchito ngati antiemetic pamene mankhwala oletsa magazi sakugwira ntchito, monga popereka cisplatin kapena zifukwa zina zomwe zimachititsa kusanza kosatha.Kugwiritsiridwa ntchito kwa ondansetron kwa amphaka kumatsutsana ndipo ena amati sayenera kugwiritsidwa ntchito pamtunduwu.

Kuyanjana kwa mankhwala Kuyanjana koopsa ndi mankhwala ena.

103639-04-9 - USP35 Muyezo:

Ondansetron Hydrochloride ili ndi zosachepera 98.0 peresenti komanso zosaposa 102.0 peresenti ya C18H19N3O · HCl, yowerengedwa pa maziko a anhydrous.

Kupaka ndi kusunga-Sungani zotengera zolimba, zosagwira kuwala.Sungani pa 25

, maulendo ololedwa pakati pa 15

ndi 30

Miyezo yolozera ya 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-imodzi.

USP Ondansetron Resolution Mixture RS

Ondansetron hydrochloride yokhala ndi pafupifupi 0.4% w/w ya onse ondansetron ogwirizana pawiri A ndi 6,6¢-methylene bis--[(1,2,3,9-tetrahydro-9-methyl-3--[(2-methyl-1H--) imidazol-1-yl)-methyl]-4H-carbazol-4-imodzi)]

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

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

Chizindikiritso-

A: Infuraredi mayamwidwe <197M>.

B: Sungunulani 20 mg mu 2 mL ya madzi, onjezerani 1 mL ya 2 M nitric acid, ndi fyuluta: filtrate imayankha kuyesedwa kwa Chloride <191>.

Madzi, Njira Ia <921>: pakati pa 9.0% ndi 10.5%.

Zotsalira pakuyatsa <281>: osapitirira 0.1%.

Malire a ondansetron okhudzana ndi mankhwala D-

Mobile phase- Konzani zosakaniza zosefedwa ndi zowonongeka za 0.02 M monobasic potassium phosphate (zosinthidwa kale ndi 1 M sodium hydroxide ku pH ya 5.4) ndi acetonitrile (80:20).Sinthani ngati kuli kofunikira (onani Kuyenerera Kwadongosolo pansi pa Chromatography <621>).

Sungunulani muyezo woyezera bwino wa USP Ondansetron Related Compound D RS mu gawo la Mobile, ndikuchepetsani mochulukira, komanso pang'onopang'ono ngati kuli kofunikira, ndi gawo la Mobile kuti mupeze yankho lomwe lili ndi kuchuluka kodziwika kwa pafupifupi 0.4 µg pa mL.

Sungunulani yoyenera ya USP Ondansetron Related Compound D RS ndi USP Ondansetron Related Compound C RS mu gawo la Mobile, ndikuchepetsani mochulukira, komanso pang'onopang'ono ngati kuli kofunikira, ndi gawo la Mobile kuti mupeze yankho lomwe lili ndi kuchuluka kwa pafupifupi 0.6 µg pa mL. ndi 1 µg pa mL, motero.

Njira yothetsera mayeso-Chotsani pafupifupi 50 mg ya Ondansetron Hydrochloride, yoyezedwa molondola, ku botolo la volumetric 100-mL, sungunulani ndi kusungunula ndi gawo la Mobile mpaka voliyumu, ndi kusakaniza.

Chromatographic system (onani Chromatography <621>) - Chromatograph yamadzimadzi imakhala ndi chowunikira cha 328-nm ndi ndime ya 4.6-mm × 25-cm yomwe ili ndi zonyamula L10.Kuthamanga kwa madzi ndi pafupifupi 1.5 ml pa mphindi.Chromatograph the System suitability solution, ndipo lembani mayankho apamwamba monga momwe adayankhidwira Ndondomeko: nthawi zosungirako zokhudzana ndi 0.8 za ondansetron zokhudzana ndi C ndi 1.0 za ondansetron zokhudzana ndi gulu D;ndi kusamvana, R, pakati pa ondansetron yokhudzana ndi chigawo C ndi ondansetron yokhudzana ndi gulu D si osachepera 1.5.Chromatograph the Standard solution, ndikujambulitsa mayankho apamwamba monga momwe adayankhidwira Ndondomeko: magwiridwe antchito omwe atsimikiziridwa kuchokera pachimake cha analyte siosachepera 400 theoretical plates;ndipo kupatuka kofanana kwa jakisoni wobwereza sikudutsa 2.0%.

Kayendetsedwe - Lowetsani padera ma voliyumu ofanana (pafupifupi 20 µL) a yankho la Standard ndi yankho la Mayeso mu chromatograph, lembani ma chromatogram, ndikuyesa mayankho a nsonga zazikulu.Werengani kuchuluka kwa ondansetron yokhudzana ndi mankhwala D mu gawo la Ondansetron Hydrochloride yotengedwa ndi formula:

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

momwe C ndi ndende, mu mg pa mL, ya USP Ondansetron Related Compound D RS mu Standard solution;W ndi kulemera, mu mg, wa Ondansetron Hydrochloride wotengedwa kukonzekera Mayeso;ndi rU ndi rS ndi malo apamwamba omwe akupezeka ku Test solution ndi Standard solution, motsatira: osapitirira 0.10% omwe amapezeka.

Chromatographic chiyero -

njira i-

Resolution solution-Sungani kuchuluka kwa USP Ondansetron Resolution Mixture RS mu methanol, ndikuchepetsa mochulukira, komanso pang'onopang'ono ngati kuli kofunikira, ndi methanol kuti mupeze yankho lodziwika bwino la 12.5 mg pa ml.

Standard solutions-Sungani muyeso woyezedwa bwino wa USP Ondansetron Hydrochloride RS mu methanol, ndi kusakaniza kuti mupeze yankho lodziwika bwino la 0.25 mg pa mL.Pang'onopang'ono chepetsani yankho ili ndi methanol kuti mupeze mayankho Okhazikika, olembedwa pansipa ndi kalata, okhala ndi nyimbo zotsatirazi:

Njira yothetsera	Dilution	Kukhazikika (µg RS pa mL)	Peresenti (%, poyerekeza ndi chitsanzo cha mayeso)
A	(1 mwa 5)	50	0.4
B	(1 mwa 10)	25	0.2
C	(1 pazithunzi 20)	12.5	0.1

Sungunulani muyeso woyezera bwino wa Ondansetron Hydrochloride mu methanol kuti mupeze yankho lomwe lili ndi 12.5 mg pa mL.Njira-Ikani Payokha 20 µL ya yankho la Mayeso, 20 µL ya yankho lililonse la Standard, ndi 20 µL ya Resolution yankho ku mbale yopyapyala ya chromatographic (onani Chromatography621) wokutidwa ndi 0.25-mm wosanjikiza wa chromatographic silica gel osakaniza.Pangani chromatogram mu zosungunulira zokhala ndi chloroform, ethyl acetate, methanol, ndi ammonium hydroxide (90:50:40:1) mpaka kutsogolo kwa zosungunulira kusuntha pafupifupi magawo atatu mwa anayi a utali wa mbale.Chotsani mbaleyo m'chipindacho, ikani kutsogolo kwa zosungunulira, ndikulola kuti zosungunulira zisungunuke.Yang'anani mbaleyo pansi pa kuwala kwa UV kwafupipafupi: kuthetsa kwathunthu kwa zigawo zitatu za Resolution solution malo akupezeka.Fananizani kulimba kwa mawanga aliwonse achiwiri omwe amawonedwa mu chromatogram ya Test solution ndi aja a malo akulu mu ma chromatogram a Standard solutions: malo aliwonse achiwiri kuchokera pa chromatogram ya Test solution yokhala ndi mtengo wa RF wofanana ndi wachiwiri wapamwamba kwambiri. Malo a Resolution solution si aakulu kapena okulirapo kuposa malo oyamba opezeka ku Standard solution A (0.4%);ndipo palibenso malo ena achiwiri kuchokera ku chromatogram ya Mayeso oyeserera omwe ali okulirapo kapena okulirapo kuposa malo oyambira omwe apezedwa kuchokera ku Standard solution B (0.2%).

njira ii-

Mobile phase ndi Chromatographic system-Pitirizani monga mwauzira mu Assay.

Yankho lokhazikika-Pitirizani monga mwalangizidwa pokonzekera Muyeso mu Assay.

Njira yothetsera-Gwiritsani ntchito kukonzekera kwa Assay.

Kachitidwe-Mosiyanirana jekeseni ma voliyumu ofanana (pafupifupi 10 µL) a njira Yoyezera ndi Mayeso mu chromatograph, lembani ma chromatogram, ndikuyesa mayankho apamwamba.Werengani kuchuluka kwa zodetsa zilizonse mu gawo la Ondansetron Hydrochloride lomwe latengedwa ndi formula:

50,000(C/W)(1/F)(ri/rS)
momwe C ndi ndende, mu mg pa mL, ya USP Ondansetron Hydrochloride RS mu Standard solution;W ndi kulemera, mu mg, wa Ondansetron Hydrochloride wotengedwa kukonzekera Mayeso;F ndiye gawo loyankhirako la zonyansa monga momwe tafotokozera mu tebulo ili;ri ndi malo okwera pachidebe chilichonse mu yankho la Mayeso;ndipo rS ndiye malo okwera kwambiri a ondansetron opezedwa kuchokera ku Standard solution: imakwaniritsa zofunikira zomwe zaperekedwa patebulo lotsatirali.

Dzina la Compound	Nthawi Yachibale Yosunga	Achibale Yankho Factor	Malire (%)
Ondansetron yokhudzana ndi C	pa 0,32	1.2	0.2
Ondansetron yokhudzana ndi mankhwala D*	ku 0,34	-	0.1
Imidazole	ku 0,49	0.3	0.2
2-methylimidazole	pa 0,54	0.4	0.2
Ondansetron	1.0	-	-
Ondansetron yogwirizana ndi A	pafupifupi 1.10	0.8	0.2
Zosadziwika	-	1.0	0.1
Zonse	-	-	0.5
* Kuyesedwa pamayeso a Limit of ondansetron yokhudzana ndi gulu D.

Kuyesa-

Mobile phase-Konzani zosakaniza zosefedwa ndi zowonongeka za 0.02 M monobasic sodium phosphate (zosinthidwa kale ndi 1 M sodium hydroxide ku pH ya 5.4) ndi acetonitrile (50:50).Sinthani ngati kuli kofunikira (onani Kuyenerera Kwadongosolo pansi pa Chromatography <621>).

Kukonzekera kokhazikika-Sungani muyeso woyezedwa bwino wa USP Ondansetron Hydrochloride RS mu gawo la Mobile, ndikuchepetsa mochulukira, komanso pang'onopang'ono ngati kuli kofunikira, ndi gawo la Mobile kuti mupeze yankho lokhala ndi ndende yodziwika pafupifupi 90 µg pa mL.

Sungunulani yoyenera ya USP Ondansetron Hydrochloride RS ndi USP Ondansetron Related Compound A RS mu Mobile gawo, ndikuchepetsani mochulukira, komanso pang'onopang'ono ngati kuli kofunikira, ndi gawo la Mobile kuti mupeze yankho lomwe lili ndi pafupifupi 90 µg pa mL ndi 20 µg pa mL. , motero.

Kukonzekera kuyesa-Kusamutsa za 45 mg ya Ondansetron Hydrochloride, yoyezedwa molondola, ku botolo la volumetric 50-mL, sungunulani ndi kusungunula ndi gawo la Mobile mpaka voliyumu, ndi kusakaniza.Pipeni 5.0 mL ya yankho ili mu botolo la voliyumu ya 50-mL, tsitsani ndi gawo la Mobile mpaka voliyumu, ndikusakaniza.

Chromatographic system (onani Chromatography <621>) - Chromatograph yamadzimadzi imakhala ndi chowunikira cha 216-nm ndi ndime ya 4.6-mm × 25-cm yomwe ili ndi zonyamula L10.Kuthamanga kwa madzi ndi pafupifupi 1.5 ml pa mphindi.Chromatograph the System suitability solution, ndipo lembani mayankho apamwamba monga momwe adayankhidwira Ndondomeko: nthawi zosungirako zokhudzana ndi 1.0 za ondansetron ndi 1.1 za ondansetron zokhudzana ndi gulu A;ndi kusamvana, R, pakati pa ondansetron yokhudzana ndi gulu A ndi ondansetron si osachepera 1.5.Chromatograph the Standard kukonzekera, ndikujambulitsa mayankho apamwamba monga momwe adayankhidwira Ndondomeko: chinthu chotsalira sichiposa 2.0;ndipo kupatuka kofanana kwa jakisoni wobwereza sikudutsa 1.5%.

Kachitidwe-Papatula jekeseni ma voliyumu ofanana (pafupifupi 10 µL) a Kukonzekera Kwanthawi zonse ndi kukonzekera kwa Assay mu chromatograph, lembani ma chromatogram, ndikuyesa mayankho a nsonga zazikulu.Werengetsani kuchuluka, mu mg, wa C18H19N3O·HCl mu gawo la Ondansetron Hydrochloride yotengedwa ndi formula:

500C(rU / rS)
momwe C ndi ndende, mu mg pa mL, wa USP Ondansetron Hydrochloride RS mu Kukonzekera kwa Standard;ndi rU ndi rS ndi malo apamwamba omwe apezedwa kuchokera ku kukonzekera kwa Assay ndi kukonzekera kwa Standard, motsatana.

103639-04-9 - Njira Yopangira:

Njira 1: Pambuyo pa zomwe 2-Bromoaniline ndi1,3-Cyclohexanedione, chotengera cha tetrahydrocarbazole chimapangidwa, ndipo chigawo (III) chimapezeka mwa kuchitapo kanthu ndi dimethylamine ndi diformaldehyde, ndikuyambitsa dimethylaminomethyl pa 2-position.3.80G ya pawiri (III) idachitidwa ndi methyl iodide kuti ipereke 5.72g ya pawiri (IV) mwa quaternizing mbali ya unyolo gulu la amino poyambitsa gulu la methyl pamalo 9. 2.0g ya pawiri (IV) ndi 2-methyl-1h. -imidazole adachitapo dimethylformamide ndikugwedeza pa 95 ℃.Kuti mupeze 0.60G ya Ondansetron.

Njira 2: Zomwe cyclohexanone ndi phenylhydrazine zinapereka tetrahydrocarbazole mu 85% zokolola.Sungunulani mu tetrahydrofuran ndi madzi, onjezerani 2,3 Dropwise pa 0 °c mu nayitrogeni, Njira yothetsera 5, 6-tetrachloro-1,4-benzoquinone mu tetrahydrofuran inalimbikitsidwa kuti ipereke mankhwala okosijeni (II) mu zokolola za 67.4%.Compound (II), ethanol, concentrated hydrochloric acid, paraformaldehyde ndi dimethylamine hydrochloride adasinthidwa pamodzi.Pambuyo pa mankhwalawa, mankhwalawa (V) adapezedwa powonjezera hydrochloric acid ku acetone ndikuyambitsa 50 ℃.Mu zokolola za 71.7%.Compound (V) ndi 2-methylimidazole adachitapo kanthu m'madzi pa 110 ℃.Kuti mupeze pawiri (VI) mu zokolola za 70.9%.Compound (VI), methyl iodide ndi potaziyamu carbonate amatenthedwa kutentha mpaka cholimbacho chitasowa.Anatsanuliridwa m'madzi, ogwedezeka, osefedwa, otsukidwa ndi madzi, ndi kukonzanso kuchokera ku methanol kuti apeze ondansetron mu zokolola za 57.2%.Sungunulani mu osakaniza acetone ndi madzi, Powonjezera anaikira hydrochloric acid kuti anachita, ondansetron hydrochloride dihydrate anapezedwa ndi zokolola za 92.6%.

Njira 3: pawiri (II), potaziyamu carbonate, acetone ndi dimethyl sulfate zinagwedezeka kutentha.Compound (VII) idapezedwa muzokolola za 91%.Compound (VII) idasungunuka mu ethanol ndipo chisakanizo cha paraformaldehyde yamunthu ndi dimethylamine hydrochloride idawonjezedwa m'magawo a reflux.Refluxing.Pambuyo pa chithandizo, pawiri (VIII) adapezedwa muzokolola za 67%.(Viii) kusungunuka mu ethanol anhydrous, mpweya wa hydrogen chloride, hydrochloride yake.Hydrochloride idawonjezeredwa m'madzi ndipo 2 idawonjezedwa pa 50 ℃.Methylimidazole, refluxing ondansetron, zokolola 70%.Idasungunuka mu isopropanol, madzi ndikuyika hydrochloric acid, ndikugwedezeka kutentha kuti ipeze ondansetron hydrochloride dihydrate muzokolola za 90.5%.