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

Sharaxaad Gaaban:

Magaca Kiimikada: Ondansetron Hydrochloride Dihydrate

CAS: 103639-04-9

Qiimaynta: 98.0 ~ 102.0% (waxaa lagu xisaabiyaa ku salaysan anhydrous)

Muuqashada: Caddaan ama Off-White Crystalline Powder

Serotonin Gaar ah (5-HT3) Soo Dhaweeye Ka soo horjeeda.Antiemetic

Xiriirka: Dr. Alvin Huang

Mobile/Wechat/WhatsApp: +86-15026746401

E-Mail: alvin@ruifuchem.com

Email noogu soo dir

Faahfaahinta Alaabta

Alaabooyinka La Xiriira

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Sharaxaad:

Shanghai Ruifu Kiimikada waa soo saaraha ugu horreeya ee Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) oo leh tayo sare.Ruifu waxa uu bixin karaa keenista adduunka oo dhan, qiimo tartan ah, adeeg aad u fiican, tiro yar iyo tiro badan oo la heli karo.Iibso Ondansetron Hydrochloride Dihydrate,Please contact: alvin@ruifuchem.com

Dhexdhexaadiyayaasha la xidhiidha:

Dhexdhexaadiyeyaasha la xidhiidha ee Ondansetron Hydrochloride Dihydrate

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

Guryaha Kiimikada:

Magaca Kiimikada	Ondansetron Hydrochloride Dihydrate
La mid ah	Ondansetron HCl Dihydrate;1,2,3,9-Tetrahydro-9-Methyl-3-[(2-Methyl-1H-imidazol-1-yl)methyl]-4H-Carbazol-4-hal Hydrochloride Dihydrate;Emeset;GR 38032 Hydrochloride Dihydrate;SN 307 Hydrochloride Dihydrate;GR 3832 HCl 2H2O;SN-37 HCl 2H2O;NSC665799 HCl 2H2O
Heerka Saamiyada	Suuqa dhexdiisa, Miisaanka Ganacsiga
Lambarka CAS	103639-04-9 (Dihydrate)
CAS RN ee la xidhiidha	99614-02-5 (Base) & 99614-01-4 (Anhydrous)
Qaanuunka molecular	C18H19N3O·HCl·2H2O
Miisaanka Molecular	365.86 g/mol
Meesha dhalaalaysa	176.0 ilaa 180.0 ℃
Xasaasi ah	Xasaasida kulaylka
Biyuhu milmayn	Ku milmay biyaha (>5 mg/ml)
Heerkulka Kaydinta	Meel Qabow & Qallalan (2 ~ 8 ℃)
COA & MSDS	La heli karo
Summada	Kiimikada Ruifu

Tilmaamaha:

Walxaha	Heerarka Kormeerka	Natiijooyinka
Muuqashada	Budada Crystalline ee Caddaan iyo Off-White	U hogaansama
Aqoonsiga
1. UV	Ugu badnaan 209, 248, 267, 310nm	U qalma
2. IR spectrum	Waafaqsan Qaab-dhismeedka	U qalma
3. Takoorka Chloride-ka	Falcelinta Hore	U qalma
Biyaha waxaa qoray Karl Fischer	9.0 ~ 10.5%	9.7%
Hadhaaga dabka	≤0.10%	0.03%
Biraha culus (Pb)	≤10pm	<10pm
Isku dhafka Ondansetron ee la xidhiidha C	≤0.20%	0.09%
Ondansetron Xiriir la leh D	≤0.10%	0.04%
Imidazole	≤0.20%	0.02%
2-Methylimidazole	≤0.20%	0.02%
Isku dhafka Ondansetron ee La Xiriira A	≤0.20%	0.05%
Waxyaabo Kale Oo Aan La Garanayn Mid Keli Ah	≤0.10%	0.07%
Wadarta wasakhda	≤0.50%	0.29%
Haraaga Solvent
Ethanol	≤5000ppm	240ppm
Qiimayn	98.0 ~ 102.0% (waxaa lagu xisaabiyaa ku salaysan anhydrous)	99.81%
Gabagabo	Alaabta waa la tijaabiyay oo waafaqay qeexitaannada

Xidhmada/Kaydinta/Raridda:

Xidhmada:Dhalo, bacda bireed ee aluminium, 25kg/Drum kartoonada, ama sida waafaqsan shuruudaha macmiilka.
Xaaladda Kaydinta:Ku kaydi weel si adag u xiran.Ku kaydi bakhaar qabow, qalalan (2 ~ 8 ℃) iyo bakhaar hawo wanaagsan leh oo ka fog walxaha aan ku habboonayn.Ka ilaali iftiinka iyo qoyaanka.
Rarida:Ku gaarsii adduunka oo dhan hawo, by FedEx/DHL Express.Bixi keenid degdeg ah oo la isku halayn karo.

Faa'iidooyinka:

Awood ku filan: Tas-hiilaad ku filan iyo farsamoyaqaanno

Adeegga Xirfadlaha: Adeegga iibsashada hal joogsi

Xidhmada OEM: Xidhmada gaarka ah iyo summada ayaa diyaar ah

Gaadhida Degdega ah: Haddii kaydku ku jiro, dammaanad bixinta saddex maalmood ah

Supply xasiloon: Hayso kayd macquul ah

Taageerada Farsamada: Xalka tignoolajiyada waa la heli karaa

Adeegga Isku-dhafka Gaarka ah: Wuxuu u dhexeeyaa garaam ilaa kiilo

Tayo Sare: Waxaa la sameeyay nidaam hubinta tayada dhamaystiran

FAQ:

Sidee loo Iibsadaa?Fadlan la xidhiidhDr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com

Khibrad 15 Sano ah?Waxaan leenahay in ka badan 15 sano oo waayo-aragnimo ah oo ku saabsan soo saarista iyo dhoofinta ee tiro balaadhan oo ah dhexdhexaad ah daawooyinka tayada sare leh ama kiimikooyinka ganaax.

Suuqyada Waaweyn?Iibiya suuqa gudaha, Waqooyiga Ameerika, Yurub, Hindiya, Kuuriya, Jabbaan, Australia, iwm.

Faa'iidooyinka?Tayada sare, qiimo jaban, adeegyo xirfadeed iyo taageero farsamo, gaarsiin degdeg ah.

TayadaHubinta?Nidaamka xakamaynta tayada adag.Qalabka xirfadlayaasha ah ee falanqaynta waxaa ka mid ah NMR, LC-MS, GC, HPLC, ICP-MS, UV, IR, OR, KF, ROI, LOD, MP, Clarity, Solubility, Imtixaanka xadka Microbial, iwm.

Tusaalooyinka?Badeecadaha intooda badani waxay bixiyaan muunado bilaash ah oo loogu talagalay qiimeynta tayada, kharashka dhoofinta waa in ay bixiyaan macaamiisha.

Hantidhawrka Warshada?Hantidhawrka warshada soo dhawoow.Fadlan horay u sii ballan.

MOQ?Ma jiro MOQ.Dalabka yar waa la aqbali karaa.

Waqtiga dirida? Haddii ay ku jirto kaydka, dammaanad bixinta saddex maalmood ah.

Gaadiidka?By Express (FedEx, DHL), hawada, badda.

Dukumentiyada?Adeegga iibka kadib: COA, MOA, ROS, MSDS, iwm waa la bixin karaa.

Isku-dhafka gaarka ah?Waxay ku siin kartaa adeegyada isku-dhafka gaarka ah si ay ugu habboonaato baahiyahaaga cilmi-baarista.

Shuruudaha Lacag-bixinta?Qaansheegga Proforma ayaa marka hore la soo diri doonaa ka dib marka la xaqiijiyo dalabka, oo lagu soo lifaaqay macluumaadka bangigayaga.Lacag bixinta T/T (Telex Transfer), PayPal, Western Union, iwm.

103639-04-9 - Khatarta iyo Badbaadada:

Xeerarka Khatarta
R25 - Sun haddii la liqo
R36/37/38 - Waxay ka xanaajisaa indhaha, habdhiska neefsiga iyo maqaarka.
Sharaxaada Badbaadada
S45 - Haddii ay dhacdo shil ama haddii aad dareento xanuun, raadso talo caafimaad isla markiiba (tus calaamadda mar kasta oo ay suurtagal tahay.)
S37/39 - Xidho galoofyada ku haboon iyo ilaalinta indhaha/wejiga
S26 - Haddii ay dhacdo in indhaha la taabto, isla markiiba ku raaci biyo badan oo raadso talo caafimaad.
Aqoonsiga UN UN 2811 6.1/PG 3
WGK Germany 3
RTECS FE6375500
HS code 29339900
Heerka khatarta 6.1 (a)
Kooxda Baakadaha II

103639-04-9 - Codsiga:

Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) waa serotonin gaar ah (5-HT3) antagonist.AntiemeticOndansetron Hydrochloride Dihydrate waxa loo isticmaalaa in lagaga hortago lalabo iyo matag ka iman kara qalliin, kiimoterabiga kansarka, ama daaweynta shucaaca.5-HT3 antagonists ee Ondansetron waa dawooyinka aasaasiga ah ee loo isticmaalo daawaynta iyo ka hortagga lallabbo iyo matag ay keento kemotherabi iyo shucaac ku-talagal ah, iyada oo la xannibayo ficillada kiimikooyinka jidhka.Waxtarku wuu ka fiican yahay metoclopramide halka suuxdintu ay ka yar tahay cyclizine ama droperidol.Si kastaba ha ahaatee, waxay saameyn yar ku leedahay matagga uu keeno jirrada dhaqdhaqaaqa.Waxaa lagu siin karaa afka, muruqa ama xididka cirbadeynta.

Ondansetron iyo Granisetron, Dolasetron waa saddex daaweyn oo caadi ah oo kiliinikada loo isticmaalo, ondansetron waa serotonin wax ku ool ah (5-HT3) xannibaadaha soo-dhoweynta kaas oo la bedeli karo oo la dooran karo, α1, α2, β1, α1, α2, β1, β2-adrenergic reseptors iyo histamine H1, H2 reseptors, it. waxay leedahay saamaynta ugu yar, waayo, H reseptors, dhexe iyo durugsan dopaminergic reseptors, ma laha saamayn lid ku ah, waxay joojin kartaa kiimoterabiga iyo radiotherapy-sababtay lallabbo iyo matag.Marka la barbardhigo metoclopramide, saameynteeda antiemetic waa ka xoog badan tahay mana lahan falcelin ka baxsan pyramidal.Matagga ay keento cisplatin, cyclophosphamide, doxorubicin, iwm. waxay soo saari kartaa saameyn degdeg ah oo xooggan.Waxay ku habboon tahay kaliya maaha daawaynta lallabbo iyo matag ay keento chemotherapy cytotoxic iyo daawaynta shucaaca, laakiin sidoo kale ka hortagga iyo daaweynta lallabbo iyo matag ay keento qalliin.Ondansetron wuxuu u shaqeeyaa sidii meel marin u ah inta u dhaxaysa dareemaha afferent visceral ee ka shaqeeya mareenka caloosha iyo mindhicirka iyo xarunta matagga gudaha xudunta laf-dhabarka, taas oo keenta diaphragm iyo dhaqdhaqaaqa murqaha caloosha.Chemotherapy iyo daaweynta shucaaca waxay sababi kartaa sii-deynta xiidmaha 5-HT waxayna sababi kartaa kicinta dareemayaasha 5-HT3, taas oo keenta matag falcelin ah.Alaabtani waxay xannibaysaa falcelintan dhacaya, isla markaana waxay xannibaysaa matagga uu kiciyay ficilka dhexe.Habka ku saabsan lallabbo iyo matag qalliin ka dib lama yaqaan.Ondansetron marka lagu daro dexamethasonecan waxay kor u qaadi kartaa saameynta anti-emetic.

103639-04-9 - Saamaynta Dhinacyada:

Tani waxay sababtaa dheecaan ka soo baxa afferent , taasoo keenta matag.Marka lagu xiro 5-HT3 reseptors, ondansetron wuxuu xannibaa kicinta serotonin, markaa matag, ka dib kicinta emetogenic sida cisplatin.Madax xanuunka ayaa ah saameynta xun ee inta badan laga soo sheego daawooyinkan.

103639-04-9 - Xogta Badbaadada:

Sunta dariiqa xididada. Saamaynta nidaamka bini'aadmiga ee marinka xididada: cagaarshow.Marka loo kululeeyo si uu u burburo waxay soo daysaa uumiga sunta ah ee NOx.

103639-04-9 - Daawooyinka iyo Dawooyinka Xoolaha:

Waxa loo istcimaalaa sidii antiemetic marka antiemetic-ga caadiga ahi aanay waxtar lahayn, sida marka la maamulayo cisplatin ama sababo kale oo matag ah.Isticmaalka ondansetron ee bisadaha waa xoogaa muran ah oo qaar ka mid ah gobolka waa inaan loo isticmaalin noocyadan.

Isdhexgalka mukhaadaraadka Isdhexgalka suurtagalka ah ee khatarta ah ee daroogooyinka kale.

103639-04-9 - USP35 Heerka:

Ondansetron Hydrochloride wuxuu ka kooban yahay wax aan ka yarayn boqolkiiba 98.0 oo aan ka badnayn boqolkiiba 102.0 ee C18H19N3O·HCl, oo lagu xisaabiyo ku salaysan anhydrous.

Baakadaha iyo kaydinta-Ku xafid weelasha cidhiidhiga ah, iftiinka u adkaysta.Ku kaydi 25

, dalxiisyada la oggol yahay inta u dhaxaysa 15

iyo 30

Heerarka Tixraaca USP <11>-

USP Ondansetron Hydrochloride RS

Isku dhafka USP Ondansetron La Xiriira A RS

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

USP Ondansetron Qaraarka Isku dhafka RS

Ondansetron hydrochloride oo leh ku dhawaad 0.4% w/w labadaba ondansetron la xidhiidha isku dhafka A iyo 6,6¢-methylene bis-[(1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-) imidazol-1-yl)-methyl]-4H-carbazol-4-hal)]

Isku dhafka USP Ondansetron La Xiriira C RS
1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-hal.

Isku dhafka USP Ondansetron La Xiriira D RS
1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-hal.

Aqoonsiga -

J: Nuugista Infrared <197M>.

B: Kala dir 20 mg 2 mL oo biyo ah, ku dar 1 mL oo ah 2 M nitric acid, iyo shaandhayn: sifeeyaha ayaa ka jawaabaya baaritaanka Chloride <191>.

Biyaha, Habka Ia <921>: inta u dhaxaysa 9.0% iyo 10.5%.

Hadhaaga dabka <281>: aan ka badnayn 0.1%.

Xadka xarunta ondansetron ee la xidhiidha D-

Marxaladda wareegta- Diyaari isku-dar la sifeeyay oo soo degsaday oo ah 0.02 M monobasic potassium phosphate (horey loogu hagaajiyay 1 M sodium hydroxide ilaa pH of 5.4) iyo acetonitrile (80:20).Samee hagaajin haddii loo baahdo (eeg Habboonaanta Nidaamka ee hoos timaada Chromatography <621>).

Xalka caadiga ah-Milan tirada saxda ah ee la miisaamay ee USP Ondansetron Laxiriirta Iskudarka D RS ee wajiga mobaylka, oo u milo tiro ahaan, iyo si tartiib tartiib ah haddii loo baahdo, iyada oo wajiga mobilada si loo helo xalka isagoo la og yahay ku dhawaad 0.4 µg mlkii.

Xalka ku habboonaanta nidaamka - Kala dir tirada ku habboon ee USP Ondansetron Combound D RS iyo USP Ondansetron Laxidhiidha Isku-xidhka C RS ee wejiga Mobile-ka, oo qiyaas ahaan tiro ahaan, iyo si tartiib tartiib ah haddii loo baahdo, iyada oo wejiga Mobile-ka si loo helo xalka isagoo ku urursan qiyaastii 0.6 µg halkii ml iyo 1 µg halkii ml, siday u kala horreeyaan.

Tijaabada xalka-Ku wareeji qiyaastii 50 mg ee Ondansetron Hydrochloride, si sax ah loo miisaamay, ilaa 100-mL weel mug leh, ku milmi oo ku milo wejiga Mobile ilaa mug, oo qas.

Nadaamka Chromatographic (eeg Chromatography <621>)-Kromaatograph-ka dareeraha ah waxa uu ku qalabaysan yahay 328-nm baaraha iyo tiir 4.6-mm × 25-cm ah oo ka kooban xirmo L10.Heerka socodka waa qiyaastii 1.5 mL daqiiqadii.Chromatograph ee xalka ku habboonaanta nidaamka, oo qor jawaabaha ugu sarreeya sida lagu faray Habraaca: waqtiyada haynta qaraabo waxay ku dhow yihiin 0.8 ee xarunta ondansetron la xidhiidha C iyo 1.0 ee isku xidhka ondansetron la xidhiidha D;iyo xallinta, R, inta u dhaxaysa ondansetron ee la xidhiidha isku dhafka C iyo ondansetron ee la xidhiidha D aan ka yarayn 1.5.Chromatograph the Standard Xalka, oo qor jawaabaha ugu sarreeya sida lagu faray Habka: waxtarka tiirka ee lagu go'aamiyay ugu sarreeya falanqaynta kama yarayn 400 taarikada aragtida;iyo weecasho heerka qaraabo ah ee cirbadaha soo noqnoqda kama badna 2.0%.

Habka- Si gooni ah u duri mugga siman (qiyaastii 20 µL) ee xalka caadiga ah iyo xalka tijaabada chromatograph-ka, duub chromatogram-yada, oo cabbir jawaabaha meelaha ugu sarreeya.Xisaabi boqolleyda ondansetron-ka la xidhiidha D ee qaybta Ondansetron Hydrochloride ee ay qaadatay qaacidada:

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

taas oo C ay tahay fiirsashada, mg per mL, ee USP Ondansetron Connection Compound D RS ee xalka caadiga ah;W waa miisaanka, mg, ee Ondansetron Hydrochloride ee la qaaday si loogu diyaariyo xalka Imtixaanka;iyo rU iyo rS waa meelaha ugu sarreeya ee laga helay xalinta tijaabada iyo xalalka caadiga ah, siday u kala horreeyaan: aan ka badnayn 0.10% ayaa la helay.

Daahirnimada Chromatographic-

habka i-

Xalka xallinta-Ku milmaan tirada USP Ondansetron Resolution Mixture RS ee methanol, oo ku milo tiro ahaan, iyo si tartiib tartiib ah haddii loo baahdo, methanol si loo helo xal isagoo la og yahay 12.5 mg halkii ml.

Xalalka caadiga ah-Mila tirada saxda ah ee USP Ondansetron Hydrochloride RS ee methanol, oo ku qas si aad u hesho xal iyada oo la og yahay fiirsashada 0.25 mg halkii ml.Tiro ahaan ugu milmi xalkan methanol si aad u hesho xalal heersare ah, oo hoos loogu qoondeeyay xaraf, isagoo leh halabuurkan soo socda:

Xalka caadiga ah	qasid	Xooga saara (µg RS halkii ml)	Boqolkiiba (%, marka la barbardhigo muunada tijaabada)
A	(1 ka mid ah 5)	50	0.4
B	(1 10kiiba)	25	0.2
C	(1 ka mid ah 20)	12.5	0.1

Tijaabada xalka-Ku milmi tirada saxda ah ee Ondansetron Hydrochloride ee methanol si aad u hesho xal ka kooban 12.5 mg halkii ml.Habka- gooni u dalbo 20 µL ee xalka Tijaabada, 20 µL ee xal kasta oo Heerarka ah, iyo 20 µL ee xalka xallinta saxan-lakab khafiif ah oo koromograafi ah (eeg Chromatography621) lagu dahaadhay lakabka 0.25-mm ee isku dhafka silica chromatographic.Ku samee chromatogramka qaab dareere ah oo ka kooban isku dhafka chloroform, ethyl acetate, methanol, iyo ammonium hydroxide (90:50:40:1) ilaa uu hore ee dareeruhu u guuro qiyaastii saddex meelood meel saddex meelood oo dhererka saxanka.Saxanka ka soo saar qolka, calaamadee meesha hore ee dareeraha, una ogolow dareeraha inuu uumi baxo.Ku baadh saxanka hoostiisa iftiinka UV-mawjadaha gaaban: xallinta dhammaystiran ee saddexda qaybood ee xalka xallinta ayaa la helay.Is barbar dhig xoojinta dhibco kasta oo labaad ee lagu arkay chromatogram-ka xalka Imtixaanka iyo kuwa dhibcaha ugu muhiimsan ee chromatogram-yada xalalka caadiga ah: meel kasta oo labaad oo ka soo jeeda chromatogram-ka xalka Imtixaanka oo leh qiime RF ah oo u dhigma kan dugsiga sare ee ugu sarreeya. meesha xalinta xalku kama weyna ama ka xoog badan tahay meesha ugu muhiimsan ee laga helay xalalka caadiga ah A (0.4%);mana jirto meel kale oo labaad oo ka timid chromatogram-ka xalka Tijaabada oo ka weyn ama ka xoog badan meesha ugu muhiimsan ee laga helay xalalka heerka B (0.2%).

habka ii-

Marxaladda wareegta iyo nidaamka Chromatographic-u wad sida lagu faray Imtixaanka.

Xalka caadiga ah-u soco sida lagu faray diyaarinta Heerka ee Assay.

Tijaabi xalka-Isticmaal diyaarinta Assay.

Habka-Si gooni ah u duri mugga siman (qiyaastii 10 µL) ee xalka caadiga ah iyo xalka Imtixaanka chromatograph-ka, duub chromatogram-yada, oo cabbir jawaabaha ugu sarreeya.Xisaabi boqolkiiba wasakh kasta ee qaybta Ondansetron Hydrochloride ee ay qaadatay qaacidada:

50,000(C/W)(1/F)(ri / rS)
taas oo C ay tahay fiirsashada, mg per mL, ee USP Ondansetron Hydrochloride RS ee xalalka Standard;W waa miisaanka, mg, ee Ondansetron Hydrochloride ee la qaaday si loogu diyaariyo xalka Imtixaanka;F waa qodobka jawaabta u dhigma ee wasakhda sida lagu qeexay shaxda la socota;ri waa meesha ugu sarreysa wasakh kasta oo ku jirta xalka Imtixaanka;iyo rS waa aagga ugu sarreeya ee ondansetron ee laga helay xalalka Heerka: waxay buuxisay shuruudaha lagu sheegay shaxda la socota.

Magaca isku dhafka ah	Waqtiga Haynta Qaraabo	Qaraabo Jawaabta Qodob	Xad (%)
Xarunta Ondansetron ee la xiriirta C	qiyaastii 0.32	1.2	0.2
Xarunta Ondansetron ee la xidhiidha D*	qiyaastii 0.34	-	0.1
Imidazole	ku saabsan 0.49	0.3	0.2
2-methylimidazole	ku saabsan 0.54	0.4	0.2
Ondansetron	1.0	-	-
Isku dhafka Ondansetron ee la xiriira A	ku saabsan 1.10	0.8	0.2
Lama garanayo	-	1.0	0.1
Wadarta	-	-	0.5
* Lagu qiyaasey tijaabada Xaddidada ondansetron ee laxiriirta D.

Imtixaan-

Marxaladda wareegta- Diyaari isku dhafka la sifeeyay oo soo degey ee 0.02 M monobasic sodium phosphate (horey loogu hagaajiyay 1 M sodium hydroxide ilaa pH of 5.4) iyo acetonitrile (50:50).Samee hagaajin haddii loo baahdo (eeg Habboonaanta Nidaamka ee hoos timaada Chromatography <621>).

U diyaargarowga caadiga ah-Mila tirada saxda ah ee USP Ondansetron Hydrochloride RS ee wejiga Mobile-ka, oo u milo tiro ahaan, iyo si tartiib ah haddii loo baahdo, iyada oo wejiga Mobile-ka si loo helo xal la og yahay oo ku saabsan 90 µg halkii ml.

Xalka ku habboonaanta nidaamka - Kala dir tirada ku habboon ee USP Ondansetron Hydrochloride RS iyo USP Ondansetron Combound A RS ee wejiga mobilada, oo u milo tiro ahaan, iyo si tartiib tartiib ah haddii loo baahdo, iyada oo wajiga mobilada si aad u hesho xal ka kooban 90 µg mL iyo 20 µg halkii mL , siday u kala horreeyaan.

Diyaarinta Assay-Ku wareeji qiyaastii 45 mg ee Ondansetron Hydrochloride, oo si sax ah loo miisaamay, ilaa 50-mL weel mug leh, ku milmi oo ku milo wejiga Mobile ilaa mug, oo isku qas.Dhuumaha 5.0 mL ee xalkan gal galaas mug leh oo 50-mL ah, ku milo wejiga Mobile ilaa mugga, oo qas.

Nadaamka Chromatographic (eeg Chromatography <621>)-Kromaatograph-ka dareeraha ah waxa uu ku qalabaysan yahay 216-nm detector iyo tiir 4.6-mm × 25-cm ah oo ka kooban xirmo L10.Heerka socodka waa qiyaastii 1.5 mL daqiiqadii.Chromatograph ee xalka ku habboonaanta nidaamka, oo qor jawaabaha ugu sarreeya sida lagu faray Habraaca: waqtiyada haynta qaraabo waxay ku dhow yihiin 1.0 ee ondansetron iyo 1.1 ee isku xidhka ondansetron ee la xidhiidha A;iyo xallinta, R, inta u dhaxaysa ondansetron la xidhiidha xayndaabka A iyo ondansetron aan ka yarayn 1.5.Chromatograph ee heerka diyaarinta, oo qor jawaabaha ugu sarreeya sida lagu faray Habka: qodobka dabada kama badna 2.0;iyo leexashada heerka qaraabo ee cirbadaha soo noqnoqda kama badna 1.5%.

Habka-Si gooni ah u duri mugga siman (qiyaastii 10 µL) ee diyaarinta Heerka iyo diyaarinta Assay chromatograph-ka, duub chromatogram-yada, oo cabbir jawaabaha meelaha ugu sarreeya.Xisaabi tirada, mg, ee C18H19N3O·HCl ee qaybta Ondansetron Hydrochloride ee ay qaadatay qaacidada:

500C (rU / rS)
taas oo C ay tahay xoojinta, mg per mL, ee USP Ondansetron Hydrochloride RS ee diyaarinta Standard;iyo rU iyo rS waa meelaha ugu sarreeya ee laga helay diyaarinta Assay iyo heerka diyaarinta, siday u kala horreeyaan.

103639-04-9 - Habka wax soo saarka:

Habka 1: Ka dib falcelinta 2-Bromoaniline iyo1,3-Cyclohexanedione, derivative tetrahydrocarbazole ayaa la sameeyay, iyo xarunta (III) waxaa lagu helay by falcelin la dimethylamine iyo diformaldehyde, iyo soo bandhigid dimethylaminomethyl at 2-booska.3.80G ee xarunta (III) ayaa lagu falceliyay methyl iodide si loo siiyo 5.72g ee xarunta (IV) iyada oo la jajabinayo kooxda amino-ka ee dhinaca dhinaca iyada oo la soo bandhigayo kooxda methyl ee booska 9. 2.0g ee xarunta (IV) iyo 2-methyl-1h -imidazole waxaa lagu falceliyay dimethylformamide iyadoo la walaaqayo 95 ℃.Si aad u hesho 0.60G of Ondansetron.

Habka 2: Dareen-celinta cyclohexanone iyo phenylhydrazine waxay siiyeen tetrahydrocarbazole 85% dhalidda.Ku milmi tetrahydrofuran iyo biyaha, ku dar 2,3 Dropwise at 0 °c ee nitrogen, Xalka 5, 6-tetrachloro-1,4-benzoquinone ee tetrahydrofuran ayaa la kiciyay si loo siiyo sheyga oksaydhka (II) ee 67.4% dhalidda.Isku-dhafka (II), ethanol, hydrochloric acid, paraformaldehyde iyo dimethylamine hydrochloride ayaa la isku daray.Daawaynta ka dib, badeecada (V) waxaa lagu helay iyadoo lagu darayo acid hydrochloric acid acetone iyo walaaqaya 50 ℃.71.7% wax-soo-saar.Isku-dhafka (V) iyo 2-methylimidazole ayaa lagu falceliyay biyaha 110 ℃.Si loo helo isku-darka (VI) ee 70.9% wax-soo-saarka.Isku-dhafka (VI), methyl iodide iyo potassium carbonate ayaa la walaaqay heerkulka qolka ilaa inta adag la waayayo.Waxaa lagu shubay biyo, walaaqay, la sifeeyay, biyo lagu dhaqay, dibna loo celiyay methanol si loo helo ondansetron 57.2% wax soo saar.Ku milmi isku dar ah acetone iyo biyo, Adigoo ku daraya acid hydrochloric ee falcelinta, ondansetron hydrochloride dihydrate waxaa lagu helay wax soo saar dhan 92.6%.

Habka 3: xarun (II), potassium carbonate, acetone iyo dimethyl sulfate ayaa lagu walaaqay heerkulka qolka.Isku-dhafka (VII) waxa lagu helay wax-soo-saar dhan 91%.Isku-dhafka (VII) ayaa lagu milmay ethanol iyo isku dhafka paraformaldehyde bini'aadamka iyo dimethylamine hydrochloride ayaa lagu daray qaybo hoos yimaada reflux.Soo noqoshadaDaaweynta ka dib, iskudarka (VIII) ayaa lagu helay 67% wax-soo-saarka.(Viii) ku milmay ethanol anhydrous, gaaska hydrogen chloride, hydrochloride-keeda.Hydrochloride waxaa lagu daray biyaha waxaana 2 lagu daray 50 ℃.Methylimidazole, refluxing ondansetron, waxay dhalisaa 70%.Waxaa lagu milmay isopropanol, biyo iyo hydrochloric acid xoog leh, waxaana lagu walaaqay heerkulka qolka si loo helo fuuq-baxa ondansetron hydrochloride ee dhalidda 90.5%.