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

Nkọwa dị mkpirikpi:

Aha Kemịkal: Ondansetron Hydrochloride Dihydrate

Nọmba ekwentị: 103639-04-9

Nyocha: 98.0 ~ 102.0% (gbakọọ na anhydrous ndabere)

Ọdịdị: White ma ọ bụ Gbanyụọ-White Crystalline Powder

Serotonin akọwapụtara (5-HT3) onye na-anabata ihe.Antiemetic

Kpọtụrụ: Dr. Alvin Huang

Mobile/Wechat/WhatsApp: +86-15026746401

E-Mail: alvin@ruifuchem.com

Zitere anyị email

Nkọwa ngwaahịa

Ngwaahịa ndị emetụtara

Mkpado ngwaahịa

Nkọwa:

Shanghai Ruifu Chemical bụ ndị na-eduga emeputa nke Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) na elu àgwà.Ruifu nwere ike ịnye nnyefe zuru ụwa ọnụ, ọnụahịa asọmpi, ọrụ magburu onwe ya, obere na nnukwu ọnụọgụ dị.Ịzụta Ondansetron Hydrochloride Dihydrate,Please contact: alvin@ruifuchem.com

Ndị etiti emetụtara:

Ihe ndị metụtara Ondansetron Hydrochloride Dihydrate

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

Njirimara kemịkalụ:

Aha Chemical	Ondansetron Hydrochloride Dihydrate
Ụdị okwu	Ondansetron HCl Dihydrate;1,2,3,9-Tetrahydro-9-Methyl-3-[(2-Methyl-1H-imidazol-1-yl) methyl] -4H-Carbazol-4-otu Hydrochloride Dihydrate;Emeset;GR 38032 Hydrochloride Dihydrate;SN 307 Hydrochloride Dihydrate;GR 3832 HCl 2H2O;SN-37 HCl 2H2O;NSC665799 HCL 2H2O
Ọnọdụ Ahịa	N'ọkwa, Azụmahịa Azụmahịa
Nọmba CAS	103639-04-9 (Dihydrate)
CAS RN metụtara	99614-02-5 (Base) & 99614-01-4 (Anhydrous)
Usoro ihe omimi	C18H19N3O·HCl·2H2O
Ibu molekụla	365.86 g/mol
Ebe Na-agbaze	176.0 ka 180.0 ℃
Mmetụta	Okpomọkụ nwere mmetụta
Mmiri Solubility	Soluble na mmiri (> 5 mg / ml)
Okpomọkụ nchekwa.	Ebe dị jụụ na nkụ (2 ~ 8 ℃)
COA & MSDS	Dị
Ụdị	Ruifu Chemical

Nkọwapụta:

Ihe	Ụkpụrụ nyocha	Nsonaazụ
Ọdịdị	Ntụ ntụ kristal na-acha ọcha ruo na-agbanyụọ	Na-akwado
njirimara
1. UV	Oke 209, 248, 267, 310nm	tozuru oke
2. IR ụdịdị dị iche iche	Dabara na Ọdịdị	tozuru oke
3. ịkpa oke nke chloride	Mmeghachi omume n'ihu	tozuru oke
Mmiri nke Karl Fischer	9.0 ~ 10.5%	9.7%
Ihe fọdụrụ na mgbanye	≤0.10%	0.03%
Ọla dị arọ (Pb)	≤10ppm	<10ppm
Ngwakọta jikọtara Ondansetron C	≤0.20%	0.09%
Ngwakọta metụtara Ondansetron D	≤0.10%	0.04%
Imidazole	≤0.20%	0.02%
2-Methylimidazole	≤0.20%	0.02%
Ngwakọta metụtara Ondansetron A	≤0.20%	0.05%
Otu adịghị ọcha ndị ọzọ amabeghị	≤0.10%	0.07%
Mgbakọta adịghị ọcha	≤0.50%	0.29%
Ihe mgbaze fọdụrụnụ
Ethanol	≤5000ppm	240ppm
Nyocha	98.0 ~ 102.0% (gbakọọ na anhydrous ndabere)	99.81%
Mmechi	A nwalela ngwaahịa a wee kwado nkọwapụta

Ngwugwu/Nkwakọba/Mbupu:

ngwugwu:Kalama, Aluminom foil bag, 25kg / Cardboard Drum, ma ọ bụ dị ka ndị ahịa chọrọ.
Ọnọdụ Nchekwa:Chekwaa n'ime akpa mechiri emechi.Chekwaa n'ebe dị jụụ, kpọrọ nkụ (2 ~ 8 ℃) yana ụlọ nkwakọba ihe ikuku na-ekupụ nke ọma pụọ na ihe ndị na-ekwekọghị ekwekọ.Chebe site na ìhè na mmiri mmiri.
Mbupu:Jiri ikuku na-ebuga ụwa niile site na FedEx / DHL Express.Nye nnyefe ngwa ngwa na ntụkwasị obi.

Uru:

Ike zuru oke: akụrụngwa na ndị ọrụ nka zuru oke

Ọrụ Ọkachamara: Otu nkwụsị ịzụrụ ọrụ

Ihe ngwugwu OEM: ngwugwu omenala na akara dị

Nnyefe ngwa ngwa: Ọ bụrụ n'ime ngwaahịa, ekwenyere nnyefe ụbọchị atọ

Nkwanye kwụsiri ike: Jikwaa ngwaahịa ezi uche dị na ya

Nkwado nka na ụzụ: Ngwọta teknụzụ dị

Ọrụ Synthesis Custom: sitere na gram ruo kilos

Ogo dị elu: guzobe usoro mmesi obi ike zuru oke

Ajụjụ:

Kedu ka esi azụta?Biko kpọtụrụDr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com

Ahụmịhe afọ 15?Anyị nwere ihe karịrị 15 afọ nke ahụmahụ na mmepụta na mbupụ nke a dịgasị iche iche nke elu mma pharmaceutical intermediates ma ọ bụ ezi kemịkal.

Isi ahịa?Na-ere ahịa ụlọ, North America, Europe, India, Korea, Japanese, Australia, wdg.

Uru?Ogo kachasị elu, ọnụ ahịa dị ọnụ ala, ọrụ ọkachamara na nkwado teknụzụ, nnyefe ngwa ngwa.

OgoNkwenye?Usoro njikwa mma siri ike.Ngwá ọrụ ọkachamara maka nyocha gụnyere NMR, LC-MS, GC, HPLC, ICP-MS, UV, IR, OR, KF, ROI, LOD, MP, Clarity, Solubility, Microbial limit test, wdg.

Ihe atụ?Ọtụtụ ngwaahịa na-enye ihe nlele efu maka nyocha dị mma, ndị ahịa kwesịrị ịkwụ ụgwọ mbupu.

Nyocha ụlọ ọrụ?Nnabata nyocha ụlọ ọrụ.Biko mee oge oge tupu oge eruo.

MOQ?Enweghị MOQ.A na-anabata obere usoro.

Oge Mbuga ozi? Ọ bụrụ n'ime ngwaahịa, ekwenyere nnyefe ụbọchị atọ.

Ụgbọ njem?Site Express (FedEx, DHL), nke ikuku, site n'oké osimiri.

Akwụkwọ?Mgbe ọrụ ahịa gasịrị: COA, MOA, ROS, MSDS, wdg nwere ike ịnye.

Synthesis omenala?Nwere ike ịnye ọrụ nhazi ahaziri iche ka ọ dabara mkpa nyocha gị nke ọma.

Usoro ịkwụ ụgwọ?A ga-ebu ụzọ ziga akwụkwọ ọnụahịa Proforma mgbe nkwenye nke iwu, kpuchiri ozi ụlọ akụ anyị.Ịkwụ ụgwọ site na T/T (Telex Nyefee), PayPal, Western Union, wdg.

103639-04-9 - Ihe ize ndụ na nchekwa:

Koodu ihe egwu
R25 - Na-egbu egbu ma ọ bụrụ na iloro ya
R36 / 37/38 - na-akpasu iwe na anya, usoro iku ume na akpụkpọ ahụ.
Nkọwapụta nchekwa
S45 - Ọ bụrụ na ihe mberede ma ọ bụ ọ bụrụ na ahụ adịghị gị mma, chọọ ndụmọdụ ahụike ozugbo (gosi akara ahụ mgbe ọ bụla enwere ike.)
S37/39 - Yiri uwe aka kwesịrị ekwesị na nchebe anya / ihu
S26 - N'ihe banyere kọntaktị na anya, kpochaa ozugbo na ọtụtụ mmiri ma chọọ ndụmọdụ ahụike.
NJ UN UN 2811 6.1/PG 3
WGK Germany 3
RTECS FE6375500
Koodu mpaghara:: 29339900
Klas 6.1 (a) egwu
Otu nkwakọ ngwaahịa II

103639-04-9 - Ngwa:

Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) bụ ihe mgbochi nnabata nke serotonin (5-HT3).Antiemetic.A na-eji Ondansetron Hydrochloride Dihydrate egbochi ọgbụgbọ na ọgbụgbọ nke nwere ike ibute site na ịwa ahụ, chemotherapy cancer, ma ọ bụ ọgwụgwọ radieshon.Ndị na-emegide ndị na-anabata 5-HT3 dị na Ondansetron bụ ọgwụ ndị bụ isi eji agwọ ma gbochie ọgbụgbọ na ọgbụgbọ na-akpata chemotherapy na ọgbụgbọ na ọgbụgbọ na-akpata redio, site na igbochi omume kemịkalụ n'ime ahụ.Ịdị irè dị mma karịa metoclopramide ebe ọ na-adịchaghị mma karịa cyclizine ma ọ bụ droperidol.Otú ọ dị, ọ na-enwe mmetụta dị nta na vomiting nke ọrịa mmegharị na-akpata.Enwere ike inye ya site n'ọnụ, site na ịgbanye ya n'ime akwara ma ọ bụ n'ime akwara.

Ondansetron na Granisetron, Dolasetron bụ ọgwụ mgbochi atọ a na-ejikarị eme ihe na ụlọ ọgwụ, ondansetron bụ onye na-anabata serotonin (5-HT3) dị irè nke na-agbanwe agbanwe na nhọrọ, maka α1, α2, β1, β2-adrenergic receptors na histamine H1, H2 anabata, ya. nwere obere mmetụta, n'ihi na H anabata, Central na mpụta dopaminergic receptors, ọ dịghị atagonistic mmetụta, ọ nwere ike ịkwụsị chemotherapy na radiotherapy-eme ka ọgbụgbọ na vomiting.E jiri ya tụnyere metoclopramide, mmetụta antiemetic ya na-esiwanye ike ma ọ nweghị mmeghachi omume extrapyramidal.Maka vomiting na-ebute site na cisplatin, cyclophosphamide, doxorubicin, wdg ọ nwere ike ịmepụta ngwa ngwa na mmetụta antiemetic.Ọ dabara na ọ bụghị naanị maka ọgwụgwọ ọgbụgbọ na ọgbụgbọ nke chemotherapy cytotoxic na ọgwụgwọ radieshon kpatara, kamakwa maka mgbochi na ọgwụgwọ ọgbụgbọ na ọgbụgbọ na-ebute site na ịwa ahụ.Ondansetron na-arụ ọrụ dị ka ebe ntụgharị n'etiti akwara visceral afferent nke na-arụ ọrụ na tract gastrointestinal na ebe a na-agbọ agbọ n'ime eriri afọ, nke na-eduga na diaphragm na mmegharị ahụ abdominal.Chemotherapy na ọgwụgwọ radieshon nwere ike ime ka ntọhapụ 5-HT nke eriri afọ na-akpata mkpali akwara site na 5-HT3 onye na-anabata ya, nke na-akpata vomiting reflex.Ngwaahịa a na-egbochi reflex a na-eme, n'otu oge ahụ ọ na-egbochi vomiting na-ebute site na ihe etiti.A maghị usoro gbasara ọgbụgbọ na ọgbụgbọ mgbe arụchara ọrụ.Ondansetron jikọtara ya na dexamethasonecan nwere ike ịkwalite mmetụta mgbochi emetic.

103639-04-9 - Mmetụta:

Nke a na-ebute mpụta afferent vagal, na-ebute vomiting.N'ijikọta ndị na-anabata 5-HT3, ondansetron na-egbochi mkpali serotonin, ya mere ọgbụgbọ, mgbe emetogenic stimuli dị ka cisplatin.Isi ọwụwa bụ mmetụta ọjọọ nke ọgwụ ndị a na-akọkarị.

103639-04-9 - Profaịlụ nchekwa:

A nsi site n'ime intravenous ụzọ.Human systemic mmetụta site intravenous ụzọ: jaundice.Mgbe ọ na-ekpo ọkụ ka ire ere, ọ na-ewepụta vapors na-egbu egbu nke NOx.

103639-04-9 - Ọgwụ na Ọgwụ anụmanụ:

A na-eji ya dị ka antiemetic mgbe antiemetics omenala adịghị arụ ọrụ, dị ka mgbe ị na-enye cisplatin ma ọ bụ maka ihe ndị ọzọ na-akpata vomiting na-adịghị agwụ agwụ.Ojiji ondansetron na nwamba dịtụ esemokwu na ụfọdụ steeti ekwesịghị iji ya mee ihe n'ụdị a.

Mmekọrịta ọgwụ na-enwe mmekọrịta dị ize ndụ na ọgwụ ndị ọzọ.

103639-04-9 - ọkọlọtọ USP35:

Ondansetron Hydrochloride nwere ihe na-erughị 98.0 pasent na ọ bụghị karịa 102.0 pasent nke C18H19N3O·HCl, gbakọọ na anhydrous ndabere.

Nkwakọ ngwaahịa na nchekwa - Chekwaa n'ime akpa siri ike, enweghị ọkụ.Na-echekwa na 25

, enwere ike ime njem nlegharị anya n'etiti 15

na 30

Ụkpụrụ ntụaka USP <11>-

USP Ondansetron Hydrochloride RS

Ngwakọta jikọrọ USP Ondansetron A RS

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

Ngwakọta Mkpebi USP Ondansetron RS

Ondansetron hydrochloride nwere ihe dị ka 0.4% w/w nke ogige metụtara ondansetron A na 6,6¢-methylene bis-[(1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-) imidazol-1-yl)-methyl]-4H-carbazol-4-otu)]

Ngwakọta jikọtara USP Ondansetron C RS
1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-otu.

Ngwakọta jikọtara USP Ondansetron D RS
1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-otu.

njirimara-

A: Infrared absorption <197M>.

B: igbari 20 mg na 2 ml mmiri, tinye 1 mL nke 2 M nitric acid, na nyo: filtrate na-anabata ule maka Chloride <191>.

Mmiri, Usoro Ia <921>: n'etiti 9.0% na 10.5%.

Ihe fọdụrụ na mgbanye <281>: ọ bụghị karịa 0.1%.

Oke nke ondansetron metụtara D-

Usoro mkpanaaka- Kwadebe ngwakọta nke 0.02 M monobasic potassium phosphate (nke emeziri na 1 M sodium hydroxide na pH nke 5.4) na acetonitrile (80:20).Mee mgbanwe ma ọ bụrụ na ọ dị mkpa (lee Dabara Sistemu n'okpuru Chromatography <621>).

Ọkọlọtọ ngwọta-Kwụsa n'ụzọ ziri ezi nke USP Ondansetron metụtara Compound D RS na usoro mkpanaaka, na itughari quantitatively, na stepwise ma ọ bụrụ na ọ dị mkpa, na Mobile usoro iji nweta ngwọta na-enwe a maara mgbanye nke banyere 0.4 µg kwa ml.

Ngwọta nke dabara na sistemụ - Gbanyụọ ọnụọgụ USP Ondansetron metụtara Compound D RS na USP Ondansetron metụtara Compound C RS na usoro mkpanaaka, wee tụgharịa n'ụzọ dị iche iche, yana n'usoro ma ọ bụrụ na ọ dị mkpa, yana usoro mkpanaaka iji nweta ihe ngwọta nwere ihe dị ka 0.6 µg kwa ml. na 1 μg kwa ml, n'otu n'otu.

Ngwọta nnwale - Nyefee ihe dị ka 50 mg nke Ondansetron Hydrochloride, atụnyere nke ọma, gaa na flask volumetric 100-mL, gbazee ma gwakọta ya na usoro Mobile ka ọ bụrụ olu, wee gwakọta ya.

Usoro Chromatographic (lee Chromatography <621>) -Kromatograph mmiri mmiri nwere ihe nchọpụta 328-nm yana kọlụm 4.6-mm × 25-cm nke nwere nkwakọba L10.Onu ogugu a bu ihe dika 1.5 ml kwa nkeji.Chromatograph nke dabara adaba sistemu, wee dekọ nzaghachi kacha elu dị ka akwadoro maka Usoro: oge njide ikwu ihe dị ka 0.8 maka ondansetron metụtara compound C na 1.0 maka ondansetron metụtara compound D;na mkpebi, R, n'etiti ondansetron metụtara compound C na ondansetron metụtara compound D abụghị ihe na-erughị 1.5.Chromatograph the Standard solution, wee dekọọ nzaghachi kacha elu dị ka akwadoro maka Usoro: arụmọrụ kọlụm nke ekpebisiri ike site na ọnụ ọgụgụ nyocha erughị 400 theoretical plates;na ndị ikwu ọkọlọtọ ndiiche maka oyiri injections abụghị ihe karịrị 2.0%.

Usoro- Wepụ iche nha nha nha (ihe dị ka 20 µL) nke ọkọlọtọ ọkọlọtọ na ngwọta Nnwale n'ime chromatograph, dekọọ chromatogram, ma tụọ nzaghachi maka ọnụ ọgụgụ ndị bụ isi.Gbakọọ pasentị nke ondansetron nwere njikọ D na mpaghara Ondansetron Hydrochloride nke usoro a were were:

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

nke C bụ ntinye uche, na mg kwa mL, nke USP Ondansetron Related Compound D RS na ngwọta ọkọlọtọ;W bụ arọ, na mg, nke Ondansetron Hydrochloride ewepụtara iji kwado ngwọta Nnwale;na rU na rS bụ mpaghara kachasị elu nke enwetara site na nyocha ule na ngwọta Standard, n'otu n'otu: ọ bụghị ihe karịrị 0.10% ka a chọtara.

Chromatographic ịdị ọcha-

usoro i-

Ngwọta mkpebi-Kwụsa ọnụọgụ USP Ondansetron Resolution Mixture RS na methanol, na itughari quantitatively, na stepwise ma ọ bụrụ na ọ dị mkpa, na methanol iji nweta ngwọta na-enwe a maara ịta nke 12.5 mg kwa ml.

Ngwọta ọkọlọtọ-Kwụsa oke USP Ondansetron Hydrochloride RS nke a tụrụ n'ụzọ ziri ezi na methanol, wee gwakọta ka ị nweta ihe ngwọta na-enwe njiri mara nke ihe dịka 0.25 mg kwa ml.Jiri methanol mee ihe n'ụzọ zuru ezu iji nweta ngwọta ọkọlọtọ, nke edepụtara n'okpuru site na akwụkwọ ozi, na-enwe ihe ndị a:

Standard ngwọta	Dilution	Ntinye uche (µg RS kwa ml)	Pasent (%, maka atụnyere ụdị nnwale)
A	(1 n'ime 5)	50	0.4
B	(1 n'ime 10)	25	0.2
C	(1 n'ime 20)	12.5	0.1

Ngwọta nwale-gbarisịa ọnụọgụ Ondansetron Hydrochloride nke ọma na methanol iji nweta ngwọta nwere 12.5 mg kwa ml.Usoro-iche iche tinye 20 µL nke ngwọta Nnwale, 20 µL nke ngwọta ọkọlọtọ ọ bụla, na 20 µL nke ngwọta mkpebi na efere chromatographic dị mkpa (lee Chromatography621) kpuchiri ya na 0.25-mm oyi akwa nke chromatographic silica gel ngwakọta.Mepụta chromatogram n'ime usoro ihe mgbaze nke nwere ngwakọta nke chloroform, ethyl acetate, methanol, na ammonium hydroxide (90:50:40:1) ruo mgbe ihu ihe mgbaze na-ebugharị ihe dị ka ụzọ atọ n'ụzọ anọ nke ogologo efere ahụ.Wepu efere ahụ site na ọnụ ụlọ, kaa akara n'ihu ihe mgbaze, ma kwe ka ihe mgbaze ahụ pụọ.Nyochaa efere ahụ n'okpuru ọkụ UV dị mkpụmkpụ: a na-ahụ mkpebi zuru oke nke akụkụ atọ nke ntụpọ mkpebi mkpebi.Tụlee ike nke ntụpọ abụọ ọ bụla a hụrụ na chromatogram nke ngwọta ule na nke ndị bụ isi ntụpọ na chromatograms nke Standard Solution: ntụpọ ọ bụla nke abụọ sitere na chromatogram nke ngwọta Nnwale nwere uru RF kwekọrọ na nke elu nke elu. ntụpọ nke Mkpebi ngwọta adịghị ibu ma ọ bụ dị ike karịa isi ntụpọ enwetara na Standard Solution A (0.4%);ma ọ nweghị ntụpọ ọzọ nke abụọ sitere na chromatogram nke ngwọta Nnwale dị ukwuu ma ọ bụ ka njọ karịa isi ntụpọ enwetara na Standard Solution B (0.2%).

usoro ii-

Usoro mkpanaka na usoro Chromatographic-Gaa n'ihu dị ka enyere ya na nyocha.

Ọkọlọtọ ngwọta-Gaa n'ihu dị ka akwadoro maka nkwadebe ọkọlọtọ na Assay.

Ngwọta nwale-Jiri nkwadebe Assay.

Usoro-iche iche nha nha nha (ihe dịka 10 µL) nke ọkọlọtọ ọkọlọtọ na ngwọta Nnwale n'ime chromatograph, dekọọ chromatograms, wee tụọ nzaghachi kacha elu.Gbakọọ pasent nke adịghị ọcha ọ bụla na mpaghara Ondansetron Hydrochloride nke usoro a were were:

50,000(C/W)(1/F)(ri / rS)
nke C bụ ntinye uche, na mg kwa mL, nke USP Ondansetron Hydrochloride RS na ngwọta Standard;W bụ arọ, na mg, nke Ondansetron Hydrochloride ewepụtara iji kwado ngwọta Nnwale;F bụ ihe nzaghachi nzaghachi nke adịghị ọcha dịka akọwara na tebụl na-esote;ri bụ ebe kachasị elu maka adịghị ọcha ọ bụla na ngwọta ule;na rS bụ mpaghara kachasị elu nke ondansetron nwetara site na ngwọta Standard: ọ na-emezu ihe ndị a chọrọ na tebụl na-esote.

Aha ngwakọta	Oge Njide Oyiyi	ikwu Nzaghachi Ihe kpatara ya	Oke (%)
Ngwakọta metụtara Ondansetron C	ihe dịka 0.32	1.2	0.2
Ngwakọta metụtara Ondansetron D*	ihe dịka 0.34	-	0.1
Imidazole	ihe dịka 0.49	0.3	0.2
2-methylimidazole	ihe dịka 0.54	0.4	0.2
Ondansetron	1.0	-	-
Ngwakọta metụtara Ondansetron A	ihe dịka 1.10	0.8	0.2
Amaghi ama	-	1.0	0.1
Mkpokọta	-	-	0.5
* Agụpụtara n'ule maka oke nke ondansetron metụtara D.

Nyocha -

Usoro mkpanaaka - Kwadebe ngwakọta nke 0.02 M monobasic sodium phosphate nke a kpochara na nke gbasasịa (emeziri ya na 1 M sodium hydroxide na pH nke 5.4) na acetonitrile (50:50).Mee mgbanwe ma ọ bụrụ na ọ dị mkpa (lee Dabara Sistemu n'okpuru Chromatography <621>).

Nkwadebe ọkọlọtọ-Kwụsa ọnụ ọgụgụ USP Ondansetron Hydrochloride RS nke a tụrụ n'ụzọ ziri ezi na usoro mkpanaaka, wee tụgharịa n'ụzọ dị iche iche, yana n'usoro ma ọ bụrụ na ọ dị mkpa, yana usoro mkpanaaka iji nweta ihe ngwọta nwere njiri mara nke ihe dịka 90 µg kwa ml.

Ngwọta nke dabara na sistemụ - Gbanyụọ ọnụọgụ USP Ondansetron Hydrochloride RS dabara adaba na USP Ondansetron Compound A RS na usoro mkpanaaka, wee gbagharịa n'ụzọ dị iche iche, yana n'usoro ma ọ bụrụ na ọ dị mkpa, na usoro mkpanaka iji nweta ihe ngwọta nwere ihe dị ka 90 µg kwa ml na 20 µg kwa mL. , n'otu n'otu.

Nkwadebe nyocha- Nyefee ihe dị ka 45 mg nke Ondansetron Hydrochloride, atụnyere nke ọma, gaa na flask volumetric 50-mL, gbazee ma gbanye ya na usoro Mobile ka ọ bụrụ olu, ma gwakọta ya.Pipet 5.0 ml nke ihe ngwọta a n'ime flask volumetric 50-mL, gbanye ya na usoro mkpanaka ruo olu, ma gwakọta ya.

Usoro Chromatographic (lee Chromatography <621>) -Kromatograph mmiri mmiri nwere ihe nchọta 216-nm yana kọlụm 4.6-mm × 25-cm nke nwere nkwakọba L10.Onu ogugu a bu ihe dika 1.5 ml kwa nkeji.Chromatograph nke dabara adaba sistemu, wee dekọ nzaghachi kacha elu dị ka akwadoro maka Usoro: oge njide ikwu ihe dị ka 1.0 maka ondansetron yana 1.1 maka ngwakọta metụtara ondansetron;na mkpebi, R, n'etiti ondansetron metụtara compound A na ondansetron erughị 1.5.Chromatograph the Standard nkwadebe, na dekọọ nzaghachi kacha elu dị ka a na-eduzi maka Usoro: ihe ọdụdụ abụghị ihe karịrị 2.0;na ndị ikwu ọkọlọtọ ndiiche maka oyiri injections abụghị ihe karịrị 1.5%.

Usoro-iche iche nha nha nha (ihe dị ka 10 µL) nke nkwadebe ọkọlọtọ na nkwadebe Assay n'ime chromatograph, dekọọ chromatogram, wee tụọ azịza maka ọnụ ọgụgụ ndị bụ isi.Gbakọọ ọnụọgụ, na mg, nke C18H19N3O·HCl n'ime akụkụ Ondansetron Hydrochloride nke usoro a were were:

500C (rU / rS)
nke C bụ ntinye uche, na mg kwa mL, nke USP Ondansetron Hydrochloride RS na nkwadebe Standard;na rU na rS bụ mpaghara kacha elu enwetara site na nkwadebe Assay na nkwado ọkọlọtọ, n'otu n'otu.

103639-04-9 - Usoro mmepụta:

Usoro 1: Mgbe mmeghachi omume nke 2-Bromoaniline na1,3-Cyclohexanedione, A na-emepụta ihe na-emepụta tetrahydrocarbazole, a na-enwetakwa ihe (III) site na mmeghachi omume na dimethylamine na diformaldehyde, na iwebata dimethylaminomethyl na ọnọdụ 2.3.80G nke onyinye (III) meghachiri ya na methyl iodide iji nye 5.72g nke onyinye (IV) site n'ime ka akụkụ amino amino dị n'akụkụ na-ewebata otu methyl na ọnọdụ 9. 2.0g nke compound (IV) na 2-methyl-1h. A na-emeghachi imidazole na dimethylformamide na-akpali akpali na 95 ℃.Iji nweta 0.60G nke Ondansetron.

Usoro 2: Mmeghachi omume nke cyclohexanone na phenylhydrazine nyere tetrahydrocarbazole na 85% mkpụrụ.Gbasaa ya na tetrahydrofuran na mmiri, tinye 2,3 Dropwise na 0 Celsius C na nitrogen, Ngwọta nke 5, 6-tetrachloro-1,4-benzoquinone na tetrahydrofuran kpaliri inye ngwaahịa oxidation (II) na 67.4% mkpụrụ.Ngwakọta (II), ethanol, concentrated hydrochloric acid, paraformaldehyde na dimethylamine hydrochloride ka agbakọrọ ọnụ.Mgbe ọgwụgwọ ahụ gasịrị, a nwetara ngwaahịa (V) site n'ịgbakwụnye hydrochloric acid na acetone na edemede na 50 ℃.N'ime 71.7% mkpụrụ.Ngwakọta (V) na 2-methylimidazole na-emeghachi omume na mmiri na 110 ℃.Iji nweta ngwakọta (VI) na 70.9% mkpụrụ.Ngwakọta (VI), methyl iodide na potassium carbonate kpalitere n'ime ụlọ okpomọkụ ruo mgbe ihe siri ike kwụsịrị.A na-awụsa ya na mmiri, kpalie ya, kpochaa, jiri mmiri saa ya, ma megharịa ya site na methanol iji nweta ondansetron na 57.2% mkpụrụ.Gbazee ya na ngwakọta nke acetone na mmiri, Site n'ịgbakwụnye hydrochloric acid na mmeghachi omume, ondansetron hydrochloride dihydrate nwetara site na mkpụrụ nke 92.6%.

Usoro 3: ngwakọta (II), potassium carbonate, acetone na dimethyl sulfate na-akpali na ụlọ okpomọkụ.E nwetara ngwakọta (VII) na mkpụrụ nke 91%.Agbazere (VII) na ethanol na ngwakọta nke paraformaldehyde mmadụ na dimethylamine hydrochloride ka agbakwunyere na akụkụ n'okpuru reflux.Refluxing.Mgbe ọgwụgwọ gasịrị, a na-enweta onyinye (VIII) na 67% mkpụrụ.(Viii) agbazere na ethanol anhydrous, hydrogen chloride gas, hydrochloride ya.A na-agbakwunye hydrochloride na mmiri ma tinye 2 na 50 ℃.Methylimidazole, refluxing ondansetron, na-emepụta 70%.A gbazere ya na isopropanol, mmiri na hydrochloric acid gbanyere mkpọrọgwụ, ma kpalie ya na ụlọ okpomọkụ iji nweta ondansetron hydrochloride dihydrate na mkpụrụ nke 90.5%.