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

Lus piav qhia luv luv:

Lub npe tshuaj: Ondansetron Hydrochloride Dihydrate

CAS: 103639-04-9 Nr

Assay: 98.0 ~ 102.0% (Xam ntawm lub hauv paus anhydrous)

Cov tsos mob: Dawb los yog Off-White Crystalline Hmoov

Ib qho tshwj xeeb Serotonin (5-HT3) Receptor Antagonist.Antiemetic

Hu rau: Dr. Alvin Huang

Txawb/Wechat/WhatsApp: +86-15026746401

E-Mail: alvin@ruifuchem.com

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Product Detail

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Khoom cim npe

Nqe lus piav qhia:

Shanghai Ruifu Chemical yog cov chaw tsim khoom ntawm Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) nrog cov khoom zoo.Ruifu tuaj yeem muab kev xa khoom thoob ntiaj teb, tus nqi sib tw, kev pabcuam zoo, me me thiab ntau ntau muaj.Yuav Ondansetron Hydrochloride Dihydrate,Please contact: alvin@ruifuchem.com

Muaj feem cuam tshuam:

Related Intermediates ntawm Ondansetron Hydrochloride Dihydrate

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

Chemical Properties:

Tshuaj npe	Ondansetron Hydrochloride Dihydrate hmoov
Synonyms	Ondansetron HCl Dihydrate;1,2,3,9-Tetrahydro-9-Methyl-3-[(2-Methyl-1H-imidazol-1-yl)methyl]-4H-Carbazol-4-ib Hydrochloride Dihydrate;Emeset;GR 38032 Hydrochloride Dihydrate;SN 307 Hydrochloride Dihydrate;GR 3832 HCl 2H2O;SN-37 HCl 2H2O;NSC665799 HCl 2H2O
Tshuag xwm txheej	Hauv Tshuag, Kev Lag Luam Loj
CAS Nr	103639-04-9 (Dihydrate)
Related CAS RN	99614-02-5 (Base) & 99614-01-4 (Anhydrous)
Molecular Formula	C18H19N3O · HCl · 2H2O
Molecular Luj	365,86 g / mol
Melting Point	176.0 txog 180.0 ℃
rhiab heev	Thaum tshav kub kub Sensitive
Dej Solubility	Soluble hauv dej (> 5 mg / ml)
Cia Temp.	Qhov chaw txias & qhuav (2 ~ 8 ℃)
COA & MSDS	Muaj
Hom	Ruifu Tshuaj

Specifications:

Cov khoom	Kev soj ntsuam Standards	Cov txiaj ntsig
Qhov tshwm sim	Dawb rau Off-White Crystalline Hmoov	Ua raws
Kev txheeb xyuas
1. UV	Max 209, 248, 267, 310nm	Tsim nyog
2. IR spectrum	Raws li tus qauv	Tsim nyog
3. Kev ntxub ntxaug ntawm cov tshuaj chloride	Kev Tawm Tsam Tawm	Tsim nyog
Dej los ntawm Karl Fischer	9.0 ~ 10.5%	9.7%
Residue ntawm Ignition	≤0.10%	0.03%
Heavy Metals (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%
Lwm yam Unknown Ib leeg impurity	≤0.10%	0.07%
Tag nrho cov impurities	≤0.50%	0.29%
Residual Solvent
Ethanol	≤5000ppm	240 ppm ua
Assay	98.0 ~ 102.0% (Xau ntawm lub hauv paus anhydrous)	99.81%
Xaus	Cov khoom tau raug kuaj & ua raws li cov specifications

Pob / Cia /Kev xa khoom:

Pob:Lub raj mis, Aluminium ntawv ci hnab, 25kg / Cardboard Nruas, los yog raws li tus neeg yuav tsum tau muaj.
Cia txias:Khaws rau hauv lub thawv kaw nruj nreem.Khaws rau hauv qhov chaw txias, qhuav (2 ~ 8 ℃) thiab lub tsev tso cua txias kom deb ntawm cov khoom tsis sib xws.Tiv thaiv los ntawm lub teeb thiab noo noo.
Shipping:Xa mus thoob ntiaj teb los ntawm huab cua, los ntawm FedEx / DHL Express.Muab kev xa khoom sai thiab txhim khu kev qha.

Qhov zoo:

Muaj peev xwm txaus: Muaj cov chaw txaus thiab cov kws tshaj lij

Kev Pabcuam Kev Ua Haujlwm: Ib qho kev pabcuam kev yuav khoom

Pob OEM: Kev cai pob thiab daim ntawv lo muaj

Kev xa khoom sai: Yog tias nyob hauv Tshuag, peb hnub xa khoom lav

Stable Supply: Khaws cov khoom tsim nyog

Kev them nyiaj yug Technical: Technology tov muaj

Kev Pabcuam Synthesis: Ntau yam ntawm grams mus rau kilos

High Quality: Tsim kom muaj kev ruaj ntseg zoo

FAQ:

Yuav Yuav Li Cas?Thov hu rauDr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com

15 Xyoo Kev Paub?Peb muaj ntau tshaj li 15 xyoo ntawm kev paub nyob rau hauv kev tsim thiab export ntawm ib tug ntau yam ntawm zoo tshuaj intermediates los yog zoo tshuaj.

Kev lag luam loj?Muag rau kev lag luam hauv tsev, North America, Europe, India, Kauslim, Nyiv, Australia, thiab lwm yam.

Qhov zoo?Superior zoo, tus nqi pheej yig, kev pabcuam tshaj lij thiab kev txhawb nqa kev pabcuam, xa khoom sai.

ZooKev lees paub?Kev tswj xyuas nruj nruj.Cov cuab yeej tshaj lij rau kev txheeb xyuas suav nrog NMR, LC-MS, GC, HPLC, ICP-MS, UV, IR, OR, KF, ROI, LOD, MP, Clarity, Solubility, Microbial limit test, thiab lwm yam.

Cov qauv?Cov khoom lag luam feem ntau muab cov qauv dawb rau kev soj ntsuam zoo, tus nqi thauj khoom yuav tsum tau them los ntawm cov neeg siv khoom.

Factory Audit?Lub Hoobkas tshawb xyuas txais tos.Thov teem caij ua ntej.

MOQ?Tsis muaj MOQ.Kev txiav txim me me tau txais.

Lub sij hawm xa tuaj? Yog hais tias nyob rau hauv Tshuag, peb hnub shipping guaranteed.

Kev thauj mus los?Los ntawm Express (FedEx, DHL), los ntawm Cua, los ntawm hiav txwv.

Cov ntaub ntawv?Kev pab cuam tom qab muag: COA, MOA, ROS, MSDS, thiab lwm yam tuaj yeem muab tau.

Kev cai Synthesis?tuaj yeem muab cov kev pabcuam sib xyaw ua ke kom haum rau koj cov kev xav tau tshawb fawb.

Cov nqe lus them nqi?Proforma invoice yuav raug xa ua ntej tom qab kev pom zoo ntawm kev txiav txim, kaw peb cov ntaub ntawv hauv tuam txhab nyiaj.Kev Them Nyiaj los ntawm T / T (Telex Transfer), PayPal, Western Union, thiab lwm yam.

103639-04-9 - Risk thiab Safety:

Risk Codes
R25 - Toxic yog nqos
R36/37/38 - Kab mob rau qhov muag, ua pa thiab tawv nqaij.
Kev nyab xeeb piav qhia
S45 - Thaum muaj xwm txheej lossis yog tias koj tsis xis nyob, nrhiav kev kho mob tam sim ntawd (qhia daim ntawv lo thaum twg los tau.)
S37/39 - Hnav cov hnab looj tes tsim nyog thiab tiv thaiv qhov muag / ntsej muag
S26 - Nyob rau hauv rooj plaub ntawm qhov muag, yaug tam sim ntawd nrog dej txaus thiab nrhiav kev kho mob.
UN IDs UN 2811 6.1/PG 3
WGK Germany 3
RTECS FE6375500
HS Code 29339900
Hazard Class 6.1(a)
Packing Group II

103639-04-9 - Daim ntawv thov:

Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) yog ib qho tshwj xeeb serotonin (5-HT3) receptor antagonist.Antiemetic.Ondansetron Hydrochloride Dihydrate yog siv los tiv thaiv xeev siab thiab ntuav uas tuaj yeem tshwm sim los ntawm kev phais, kho mob qog noj ntshav, lossis kev kho hluav taws xob.5-HT3 receptor antagonists nyob rau hauv Ondansetron yog thawj cov tshuaj siv los kho thiab tiv thaiv chemotherapy-induced xeev siab thiab ntuav thiab radiotherapy-induced xeev siab thiab ntuav, los ntawm kev thaiv cov kev ua ntawm cov tshuaj nyob rau hauv lub cev.Cov kev ua tau zoo yog zoo dua li metoclopramide thaum tsawg sedating dua cyclizine los yog droperidol.Txawm li cas los xij, nws muaj qhov cuam tshuam me me rau ntuav los ntawm kev mob hnyav.Nws tuaj yeem muab los ntawm qhov ncauj, los ntawm kev txhaj tshuaj rau hauv cov leeg lossis hauv cov leeg.

Ondansetron thiab Granisetron, Dolasetron yog peb hom tshuaj siv tshuaj tua kab mob, ondansetron yog ib qho zoo serotonin (5-HT3) receptor blocker uas yog thim rov qab thiab xaiv, rau α1, α2, β1, β2-adrenergic receptors thiab histamine H1, H2 receptors, muaj cov nyhuv tsawg, rau H receptors, nruab nrab thiab peripheral dopaminergic receptors, nws tsis muaj antagonistic nyhuv, nws muaj peev xwm suppress tus kws khomob thiab radiotherapy-vim xeev siab thiab ntuav.Piv nrog rau metoclopramide, nws cov nyhuv antiemetic muaj zog dua thiab nws tsis muaj cov tshuaj tiv thaiv extrapyramidal.Rau ntuav induced los ntawm cisplatin, cyclophosphamide, doxorubicin, thiab lwm yam. nws yuav ua tau sai thiab muaj zog antiemetic nyhuv.Nws yog qhov tsim nyog tsis yog rau kev kho mob xeev siab thiab ntuav los ntawm cytotoxic chemotherapy thiab kev kho hluav taws xob, tab sis kuj rau kev tiv thaiv thiab kho mob xeev siab thiab ntuav vim yog kev phais.Ondansetron ua haujlwm raws li qhov chaw hla nruab nrab ntawm cov hlab ntsha visceral afferent activated nyob rau hauv lub plab hnyuv thiab ntuav chaw nyob rau hauv tus txha caj qaum, uas ua rau lub diaphragm thiab plab cov leeg txav.Kev kho tshuaj khomob thiab kev kho hluav taws xob tuaj yeem ua rau cov hnyuv 5-HT tso tawm thiab ua rau cov hlab ntsha vagus stimulation los ntawm 5-HT3 receptor, uas ua rau ntuav reflex.Cov khoom no blocks qhov reflex tshwm sim, tib lub sij hawm nws thaiv qhov ntuav tshwm sim los ntawm kev ua haujlwm hauv nruab nrab.Cov txheej txheem hais txog kev xeev siab thiab ntuav tom qab tsis paub meej.Ondansetron ua ke nrog dexamethasonecan tuaj yeem txhim kho cov nyhuv anti-emetic.

103639-04-9 - Cov teebmeem:

Qhov no ua rau vagal afferent tawm, inducing ntuav.Hauv kev khi rau 5-HT3 receptors, ondansetron blocks serotonin stimulation, yog li ntuav, tom qab emetogenic stimuli xws li cisplatin.Kev mob taub hau yog qhov feem ntau tshwm sim tsis zoo ntawm cov tshuaj no.

103639-04-9 - Kev Nyab Xeeb Profile:

Ib qho tshuaj lom los ntawm txoj hlab ntshav. Tib neeg cov teebmeem los ntawm txoj hlab ntshav: jaundice.Thaum rhuab mus rau decomposition nws emits tshuaj lom vapors ntawm NOx.

103639-04-9 - Veterinary Drugs thiab Kev Kho Mob:

Siv los ua cov tshuaj tiv thaiv thaum cov tshuaj antiemetics tsis zoo, xws li thaum noj cisplatin lossis rau lwm yam ua rau ntuav ntuav.Kev siv ondansetron hauv miv yog qhov teeb meem me ntsis thiab qee lub xeev nws yuav tsum tsis txhob siv rau hauv hom no.

Kev sib cuam tshuam yeeb tshuaj Muaj peev xwm cuam tshuam nrog lwm yam tshuaj.

103639-04-9 - USP35 Txuj:

Ondansetron Hydrochloride muaj tsis tsawg tshaj li 98.0 feem pua thiab tsis ntau tshaj 102.0 feem pua ntawm C18H19N3O·HCl, xam nyob rau hauv lub hauv paus anhydrous.

Ntim thiab khaws cia-Txuag hauv cov thawv nruj, lub teeb-tiv taus.Khaws ntawm 25

, excursions tso cai nruab nrab ntawm 15

thiab 30

USP Reference cov qauv <11>-

Tom ntej: USP Ondansetron Hydrochloride RS

USP Ondansetron Related Compound A RS

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

USP Ondansetron Resolution Mixture RS

Ondansetron hydrochloride muaj kwv yees li 0.4% w/w ntawm ob qho tib si ondansetron muaj feem xyuam nrog A thiab 6,6¢-methylene bis-[(1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-) imidazol-1-yl)-methyl]-4H-carbazol-4-ib)]

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

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

Kev txheeb xyuas-

A: Infrared Absorption <197M>.

B: Dissolve 20 mg nyob rau hauv 2 mL dej, ntxiv 1 mL ntawm 2 M nitric acid, thiab lim: lub filtrate teb rau qhov kev xeem rau Chloride <191>.

Dej, Txoj Kev Ia <921>: nruab nrab ntawm 9.0% thiab 10.5%.

Residue ntawm ignition <281>: tsis ntau tshaj 0.1%.

Kev txwv ntawm ondansetron muaj feem xyuam nrog D-

Txawb theem- Npaj cov lim thiab degassed sib tov ntawm 0.02 M monobasic potassium phosphate (yav tas los hloov nrog 1 M sodium hydroxide rau pH ntawm 5.4) thiab acetonitrile (80:20).Ua kev hloov kho yog tias tsim nyog (saib System Suitability hauv Chromatography <621>).

Cov txheej txheem kev daws teeb meem-Dissolve ib qho hnyav hnyav ntawm USP Ondansetron Related Compound D RS nyob rau hauv Mobile theem, thiab dilute quantitatively, thiab stepwise yog tias tsim nyog, nrog Mobile theem kom tau txais ib tug paub concentration ntawm txog 0.4 µg ib mL.

System suitability tov-Dissolve haum kom muaj nuj nqis ntawm USP Ondansetron Related Compound D RS thiab USP Ondansetron Related Compound C RS nyob rau hauv Mobile theem, thiab dilute quantitatively, thiab stepwise yog tias tsim nyog, nrog Mobile theem kom tau ib tug concentration ntawm txog 0.6 µg ib mL thiab 1 µg per mL, feem.

Kev ntsuas tshuaj-Hloov txog 50 mg ntawm Ondansetron Hydrochloride, ntsuas kom raug, mus rau 100-mL ntim ntim, yaj hauv thiab dilute nrog Txawb theem rau ntim, thiab sib tov.

Chromatographic system (saib Chromatography <621>)-Cov kua chromatograph yog nruab nrog 328-nm ntes thiab 4.6-mm × 25-cm kem uas muaj cov ntim L10.Tus nqi ntws yog li 1.5 mL ib feeb.Chromatograph qhov kev daws teeb meem tsim nyog, thiab sau cov lus teb ncov raws li qhia rau Cov Txheej Txheem: cov sij hawm khaws cov txheeb ze yog kwv yees li 0.8 rau ondansetron ntsig txog compound C thiab 1.0 rau ondansetron ntsig txog compound D;thiab qhov kev daws teeb meem, R, ntawm ondansetron ntsig txog compound C thiab ondansetron ntsig txog compound D tsis tsawg dua 1.5.Chromatograph cov txheej txheem kev daws teeb meem, thiab sau cov lus teb ncov raws li tau qhia rau Cov Txheej Txheem: cov kab ke kev ua haujlwm tau txiav txim siab los ntawm cov ntsuas ntsuas siab tsis tsawg dua 400 daim phiaj theoretical;thiab tus txheeb ze tus qauv sib txawv rau kev txhaj tshuaj replicate tsis ntau tshaj 2.0%.

Cov txheej txheem- Cais cov ntim sib npaug (kwv yees li 20 µL) ntawm cov txheej txheem kev daws teeb meem thiab cov tshuaj ntsuam xyuas rau hauv cov chromatograph, sau cov chromatograms, thiab ntsuas cov lus teb rau cov peaks loj.Xam cov feem pua ntawm ondansetron muaj feem xyuam nrog D hauv feem ntawm Ondansetron Hydrochloride coj los ntawm cov mis:

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

nyob rau hauv uas C yog qhov concentration, nyob rau hauv mg ib mL, ntawm USP Ondansetron Related Compound D RS nyob rau hauv tus txheej txheem tov;W yog qhov hnyav, hauv mg, ntawm Ondansetron Hydrochloride coj los npaj cov tshuaj ntsuam xyuas;thiab rU thiab rS yog qhov chaw siab tshaj plaws tau txais los ntawm Kev Ntsuas Kev Ntsuas thiab Kev Ntsuas Kev Ntsuas, raws li: tsis pub ntau tshaj 0.10% pom.

Chromatographic purity-

txoj kev i-

Kev daws teeb meem-Dissolve ib tug ntau ntawm USP Ondansetron Resolution Mixture RS nyob rau hauv methanol, thiab dilute quantitatively, thiab stepwise yog tias tsim nyog, nrog methanol kom tau txais ib tug paub concentration ntawm 12.5 mg ib mL.

Cov txheej txheem kev daws teeb meem-Dissolve ib qho hnyav hnyav ntawm USP Ondansetron Hydrochloride RS hauv methanol, thiab sib tov kom tau txais cov tshuaj uas muaj cov ntsiab lus paub txog ntawm 0.25 mg ib mL.Quantitatively dilute cov tshuaj no nrog methanol kom tau txais cov qauv kev daws teeb meem, tsim hauv qab no los ntawm tsab ntawv, muaj cov hauv qab no:

Txuj kev daws teeb meem	Dilution	Concentration (µg RS per mL)	Feem pua (%, piv nrog cov qauv kuaj)
A	(1 hauv 5)	50	0.4
B	(1 ntawm 10)	25	0.2
C	(1 ntawm 20)	12.5 Nws	0.1

Kuaj cov tshuaj-Dissolve ib qho hnyav hnyav ntawm Ondansetron Hydrochloride hauv methanol kom tau txais cov tshuaj uas muaj 12.5 mg ib mL.Cov txheej txheem-Tshwj xeeb siv 20 µL ntawm cov tshuaj ntsuam xyuas, 20 µL ntawm txhua qhov kev daws teeb meem, thiab 20 µL ntawm Kev daws teeb meem rau cov txheej nyias nyias chromatographic phaj (saib Chromatography621 ib) coated nrog 0.25-mm txheej ntawm chromatographic silica gel sib tov.Tsim cov chromatogram hauv cov kuab tshuaj uas muaj cov sib xyaw ntawm chloroform, ethyl acetate, methanol, thiab ammonium hydroxide (90: 50: 40: 1) kom txog rau thaum cov kuab tshuaj pem hauv ntej tau txav mus txog peb feem plaub ntawm qhov ntev ntawm lub phaj.Tshem lub phaj los ntawm lub chamber, kos cov kuab tshuaj pem hauv ntej, thiab cia cov kuab tshuaj evaporate.Tshawb xyuas lub phaj nyob rau hauv luv-yav wavelength UV teeb: ua tiav kev daws teeb meem ntawm peb lub ntsiab lus ntawm Kev daws teeb meem qhov chaw pom.Sib piv qhov sib zog ntawm ib qho chaw thib ob uas tau pom nyob rau hauv chromatogram ntawm Kev Ntsuas Kev Ntsuas nrog cov ntawm cov chaw tseem ceeb hauv chromatograms ntawm cov qauv kev daws teeb meem: ib qho chaw thib ob los ntawm chromatogram ntawm Kev Ntsuas Kev daws teeb meem uas muaj tus nqi RF sib raug rau qhov nruab nrab theem nrab. qhov chaw ntawm qhov kev daws teeb meem tsis loj los yog khaus ntau dua li qhov chaw tseem ceeb tau txais los ntawm Standard tov A (0.4%);thiab tsis muaj lwm qhov chaw thib ob los ntawm chromatogram ntawm Kev Ntsuas Kev Ntsuas yog qhov loj dua lossis hnyav dua li qhov chaw tseem ceeb tau txais los ntawm Standard tov B (0.2%).

method ii-

Txawb theem thiab Chromatographic system-Ua raws li qhia hauv Kev Tshawb Fawb.

Standard solution-Ua raws li qhia rau Standard npaj hauv Assay.

Test solution-Siv qhov Assay npaj.

Cov txheej txheem-Kev txhaj tshuaj sib npaug (kwv yees li 10 µL) ntawm cov txheej txheem kev daws teeb meem thiab cov tshuaj ntsuam xyuas rau hauv chromatograph, sau cov chromatograms, thiab ntsuas cov lus teb siab kawg.Xam cov feem pua ntawm txhua qhov impurity hauv feem ntawm Ondansetron Hydrochloride coj los ntawm cov mis:

50,000 (C / W) (1 / F) (ri / rS)
nyob rau hauv uas C yog qhov concentration, nyob rau hauv mg ib mL, ntawm USP Ondansetron Hydrochloride RS nyob rau hauv tus txheej txheem tov;W yog qhov hnyav, hauv mg, ntawm Ondansetron Hydrochloride coj los npaj cov tshuaj ntsuam xyuas;F yog tus txheeb ze teb qhov tseem ceeb ntawm cov impurities raws li tau piav nyob rau hauv cov lus nrog;ri yog lub ncov cheeb tsam rau txhua impurity nyob rau hauv lub Test tov;thiab rS yog qhov chaw siab tshaj ntawm ondansetron tau txais los ntawm Cov Txheej Txheem Kev daws teeb meem: nws ua tau raws li qhov yuav tsum tau muab rau hauv cov lus nrog.

Lub Npe Lub Npe	Lub Sijhawm Retention Relative	kwv tij Teb Qhov xwm txheej	Txwv (%)
Ondansetron muaj feem xyuam nrog C	cav 0.32	1.2	0.2
Ondansetron muaj feem xyuam nrog D*	ua 0,34	—	0.1
Imidazole	cav 0,49	0.3	0.2
2-methylimidazole	cav 0,54	0.4	0.2
Ondansetron	1.0	—	—
Ondansetron muaj feem xyuam nrog A	cav 1.10	0.8 ua	0.2
Tsis paub	—	1.0	0.1
Tag nrho	—	—	0.5
* Quantified nyob rau hauv kev xeem rau txwv ntawm ondansetron muaj feem xyuam compound D.

Assay-

Txawb theem-Npaj lim thiab degassed sib tov ntawm 0.02 M monobasic sodium phosphate (yav tas los kho nrog 1 M sodium hydroxide rau pH ntawm 5.4) thiab acetonitrile (50:50).Ua kev hloov kho yog tias tsim nyog (saib System Suitability hauv Chromatography <621>).

Cov txheej txheem kev npaj-Dissolve ib tug raug hnyav kom muaj nuj nqis ntawm USP Ondansetron Hydrochloride RS nyob rau hauv Mobile theem, thiab dilute quantitatively, thiab stepwise yog tias tsim nyog, nrog rau theem Mobile kom tau txais ib tug paub concentration ntawm txog 90 µg ib mL.

System haumxeeb tov-Dissolve haum kom muaj nuj nqis ntawm USP Ondansetron Hydrochloride RS thiab USP Ondansetron Related Compound A RS nyob rau hauv lub Mobile theem, thiab dilute quantitatively, thiab stepwise yog tias tsim nyog, nrog rau theem Mobile kom tau ib tug tov uas muaj txog 90 µg ib mL thiab 20 µg ib mL , raws.

Assay npaj-Hloov txog 45 mg ntawm Ondansetron Hydrochloride, raug hnyav, mus rau 50-mL ntim ntim, yaj hauv thiab dilute nrog Txawb theem rau ntim, thiab sib tov.Pipet 5.0 mL ntawm cov tshuaj no rau hauv 50-mL ntim ntim, dilute nrog Txawb theem rau ntim, thiab sib tov.

Chromatographic system (saib Chromatography <621>)-Cov kua chromatograph yog nruab nrog 216-nm ntes thiab 4.6-mm × 25-cm kem uas muaj cov ntim L10.Tus nqi ntws yog li 1.5 mL ib feeb.Chromatograph qhov kev daws teeb meem tsim nyog, thiab sau cov lus teb ncov raws li qhia rau Cov Txheej Txheem: cov sij hawm tuav cov txheeb ze yog kwv yees li 1.0 rau ondansetron thiab 1.1 rau ondansetron muaj feem xyuam nrog A;thiab kev daws teeb meem, R, nruab nrab ntawm ondansetron ntsig txog compound A thiab ondansetron tsis tsawg dua 1.5.Chromatograph tus txheej txheem kev npaj, thiab sau cov lus teb ncov raws li qhia rau Cov Txheej Txheem: qhov tailing factor tsis ntau tshaj 2.0;thiab tus txheeb ze tus qauv sib txawv rau replicate txhaj tshuaj tsis ntau tshaj 1.5%.

Cov txheej txheem-Kev txhaj tshuaj sib npaug (kwv yees li 10 µL) ntawm Cov Txheej Txheem Kev Npaj thiab Kev Ntsuas Kev Ntsuas rau hauv cov chromatograph, sau cov chromatograms, thiab ntsuas cov lus teb rau cov peaks loj.Xam qhov ntau, hauv mg, ntawm C18H19N3OHCl hauv feem ntawm Ondansetron Hydrochloride coj los ntawm cov mis:

500C (rU / rS)
nyob rau hauv uas C yog qhov concentration, nyob rau hauv mg ib mL, ntawm USP Ondansetron Hydrochloride RS nyob rau hauv tus txheej txheem npaj;thiab rU thiab rS yog qhov chaw siab tshaj plaws tau txais los ntawm Assay kev npaj thiab kev npaj Standard, feem.

103639-04-9 - Txheej Txheem:

Txoj Kev 1: Tom qab cov tshuaj tiv thaiv ntawm 2-Bromoaniline thiab1,3-Cyclohexanedione, tetrahydrocarbazole derivative yog tsim, thiab cov compound (III) yog tau los ntawm reacting nrog dimethylamine thiab diformaldehyde, thiab qhia dimethylaminomethyl ntawm 2-txoj hauj lwm.3.80G ntawm compound (III) tau reacted nrog methyl iodide muab 5.72g ntawm compound (IV) los ntawm quaternizing sab saw amino pawg thaum qhia cov methyl pawg ntawm txoj hauj lwm 9. 2.0g ntawm compound (IV) thiab 2-methyl-1h -imidazole tau reacted hauv dimethylformamide nrog nplawm ntawm 95 ℃.Yuav kom tau txais 0.60G ntawm Ondansetron.

Txoj Kev 2: Cov tshuaj tiv thaiv ntawm cyclohexanone thiab phenylhydrazine muab tetrahydrocarbazole hauv 85% tawm los.Dissolve nws nyob rau hauv tetrahydrofuran thiab dej, ntxiv 2,3 Dropwise ntawm 0 ° c nyob rau hauv nitrogen, ib tug tov ntawm 5, 6-tetrachloro-1,4-benzoquinone nyob rau hauv tetrahydrofuran tau nplawm kom muab cov oxidation khoom (II) nyob rau hauv 67.4% tawm los.Compound (II), ethanol, concentrated hydrochloric acid, paraformaldehyde thiab dimethylamine hydrochloride tau refluxed ua ke.Tom qab kev kho mob, cov khoom (V) tau txais los ntawm kev ntxiv cov concentrated hydrochloric acid rau acetone thiab nplawm ntawm 50 ℃.Hauv 71.7% tawm los.Cov tshuaj (V) thiab 2-methylimidazole tau tshwm sim hauv dej ntawm 110 ℃.Kom tau txais kev sib xyaw (VI) hauv 70.9% tawm los.Compound (VI), methyl iodide thiab potassium carbonate tau nplawm ntawm chav tsev kub kom txog thaum cov khoom ploj.Nws tau nchuav rau hauv dej, nplawm, lim, ntxuav nrog dej, thiab recrystallized los ntawm methanol kom tau ondansetron hauv 57.2% tawm los.Dissolve nws nyob rau hauv ib tug sib tov ntawm acetone thiab dej, Los ntawm kev ntxiv concentrated hydrochloric acid rau cov tshuaj tiv thaiv, ondansetron hydrochloride dihydrate tau nrog ib tug yield ntawm 92.6%.

Txoj kev 3: compound (II), poov tshuaj carbonate, acetone thiab dimethyl sulfate tau nplawm ntawm chav tsev kub.Compound (VII) tau txais los ntawm 91%.Compound (VII) tau yaj nyob rau hauv ethanol thiab ib tug sib tov ntawm tib neeg paraformaldehyde thiab dimethylamine hydrochloride tau ntxiv nyob rau hauv feem nyob rau hauv reflux.Refluxing.Tom qab kev kho mob, compound (VIII) tau txais 67% tawm los.(Viii) yaj nyob rau hauv anhydrous ethanol, hydrogen chloride gas, nws hydrochloride.Cov hydrochloride tau ntxiv rau dej thiab 2 ntxiv ntawm 50 ℃.Methylimidazole, refluxing ondansetron, tawm los 70%.Nws tau yaj nyob rau hauv isopropanol, dej thiab concentrated hydrochloric acid, thiab nplawm nyob rau hauv chav tsev kub kom tau ondansetron hydrochloride dihydrate nyob rau hauv ib tug yield ntawm 90.5%.