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

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

ʻO ka wehewehe pōkole:

Inoa Kemika: Ondansetron Hydrochloride Dihydrate

CAS: 103639-04-9

Assay: 98.0 ~ 102.0% (I helu ʻia ma ke kumu anhydrous)

ʻAno: Keʻokeʻo a i ʻole Keʻokeʻo Crystalline Powder

He Antagonist Receptor Serotonin (5-HT3) Kūikawā.Antiemetic

Hoʻokaʻaʻike: Kauka Alvin Huang

Mobile/Wechat/WhatsApp: +86-15026746401

E-Mail: alvin@ruifuchem.com

E hoʻouna i ka leka uila iā mākou

Huahana Huahana

Nā Huahana Pili

Huahana Huahana

wehewehe:

ʻO Shanghai Ruifu Chemical ka mea hana nui o Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) me ke kūlana kiʻekiʻe.Hiki iā Ruifu ke hāʻawi aku i ka honua holoʻokoʻa, ke kumukūʻai hoʻokūkū, ka lawelawe maikaʻi loa, nā mea liʻiliʻi a me ka nui.E kūʻai i ka Ondansetron Hydrochloride Dihydrate,Please contact: alvin@ruifuchem.com

Nā Kūwaena Pili:

Nā Kūwaena Pili o Ondansetron Hydrochloride Dihydrate

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

Na Waiwai Kemika:

Inoa Kimia	ʻO Ondansetron Hydrochloride Dihydrate
Nā huaʻōlelo like	Ondansetron HCl Dihydrate;1,2,3,9-Tetrahydro-9-Methyl-3-[(2-Methyl-1H-imidazol-1-yl)methyl]-4H-Carbazol-4-one Hydrochloride Dihydrate;ʻEmeset;GR 38032 Hydrochloride Dihydrate;SN 307 Hydrochloride Dihydrate;GR 3832 HCl 2H2O;SN-37 HCl 2H2O;NSC665799 HCl 2H2O
Kūlana Kūʻai	Ma ka Waihona, Ka Uuna Kūʻai
Helu CAS	103639-04-9 (Dihydrate)
CAS RN pili	99614-02-5 (Kumu) & 99614-01-4 (Anhydrous)
ʻĀpana Molekala	C18H19N3O·HCl·2H2O
Kaumaha Molecular	365.86 g/mol
Lae hehee	176.0 a 180.0 ℃
Pilikino	Paʻa wela
Hiki i ka wai	Hiki i ka wai (>5 mg/ml)
Waihona Temp.	Wahi anuanu a maloo (2~8 ℃)
COA & MSDS	Loaʻa
Brand	Kemika Ruifu

Nā kikoʻī:

Nā mea	Nā Kūlana Nānā	Nā hualoaʻa
Ka nana aku	Keʻokeʻo a i ka pauka kristal keʻokeʻo	Hoʻokō
ʻIkepili
1. UV	Max 209, 248, 267, 310nm	Kupono
2. IR spectrum	Kūlike i ka hoʻolālā	Kupono
3. Hoowahawaha i ka Chloride	Pane i mua	Kupono
Wai na Karl Fischer	9.0-10.5%	9.7%
Koena ma ka Ignition	≤0.10%	0.03%
Nā Metala Kaumaha (Pb)	≤10ppm	<10ppm
Ondansetron Huihui Pili C	≤0.20%	0.09%
Ondansetron pili pūhui D	≤0.10%	0.04%
Imidazole	≤0.20%	0.02%
2-Methylimidazole	≤0.20%	0.02%
Ondansetron Huihui Pili A	≤0.20%	0.05%
ʻO nā mea haumia hoʻokahi i ʻike ʻole ʻia	≤0.10%	0.07%
Huina paumaele	≤0.50%	0.29%
Koena Solvent
Ethanol	≤5000ppm	240ppm
Hoʻāʻo	98.0~102.0% (I helu ʻia ma ke kumu anhydrous)	99.81%
Ka hopena	Ua hoʻāʻo ʻia ka huahana a hoʻokō i nā kikoʻī

Pūʻolo/Paʻa/Hoʻouna:

Pūʻolo:ʻO ka ʻōmole, ʻeke ʻeke alumini, 25kg / pahu pahu pahu, a i ʻole e like me ka makemake o ka mea kūʻai aku.
Kūlana mālama:E mālama i loko o kahi pahu paʻa.E kūʻai i loko o kahi hale kūʻai maloʻo, maloʻo (2 ~ 8 ℃) a me ka ventilated maikaʻi mai nā mea like ʻole.E pale i ka malamalama a me ka wai.
Hoʻouna:Hāʻawi i ka honua ma ka lewa, e FedEx / DHL Express.Hāʻawi wikiwiki a hilinaʻi hoʻi.

Pono:

ʻO ka mana kūpono: lawa nā lako a me nā ʻenehana

ʻOihana Hoʻonaʻauao: Hoʻokahi lawelawe kūʻai kūʻai

Puke OEM: Loaʻa ka pūʻolo maʻamau a me ka lepili

Hoʻouna wikiwiki: Inā i loko o ke kumukūʻai, ʻekolu lā hoʻouna i hōʻoia ʻia

Hoʻolako Paʻa: E mālama i ka waiwai kūpono

Kākoʻo ʻenehana: Loaʻa ka hopena ʻenehana

Hana Hana Hana Kuʻuna: Mai ka grama a hiki i ke kilo

Kūlana Kiʻekiʻe: Hoʻokumu i kahi ʻōnaehana hōʻoia maikaʻi piha

FAQ:

Pehea e kūʻai ai?E ʻoluʻolu e kelepona maiDr. Alvin Huang: sales@ruifuchem.com or alvin@ruifuchem.com

15 mau makahiki ʻike?Loaʻa iā mākou ma mua o 15 mau makahiki o ka ʻike i ka hana ʻana a me ka hoʻokuʻu ʻana aku i kahi ākea ākea o nā intermediates pharmaceutical kiʻekiʻe a i ʻole nā kemika maikaʻi.

Mākeke Nui?E kūʻai aku i ka mākeke kūloko, ʻAmelika ʻĀkau, ʻEulopa, India, Korea, Iapana, Australia, etc.

Nā pono?ʻO ke kūlana kiʻekiʻe, ke kumukūʻai kūpono, nā lawelawe ʻoihana a me ke kākoʻo ʻenehana, ka lawe wikiwiki ʻana.

ʻAno maikaʻiHōʻoiaʻiʻo?Pūnaehana hoʻomalu maikaʻi koʻikoʻi.ʻO nā lako ʻoihana no ka nānā ʻana ʻo NMR, LC-MS, GC, HPLC, ICP-MS, UV, IR, OR, KF, ROI, LOD, MP, Clarity, Solubility, Microbial limit test, etc.

Nā laʻana?Hāʻawi ka hapa nui o nā huahana i nā laʻana manuahi no ka loiloi maikaʻi, pono e uku ʻia ke kumukūʻai e nā mea kūʻai aku.

Hooia Hale Hana?Welina mai ka loiloi hale hana.E ʻoluʻolu e hoʻopaʻa manawa ma mua.

MOQ?ʻAʻohe MOQ.ʻAe ʻia ke kauoha liʻiliʻi.

Manawa Hoʻouna? Inā i loko o ka waihona, ʻekolu lā hoʻouna ʻia.

Kaʻahele?Ma ka Express (FedEx, DHL), ma ka Air, ma ke Kai.

Nā palapala?Ma hope o ka lawelawe kūʻai: COA, MOA, ROS, MSDS, etc.

Hoʻohui Kuʻuna?Hiki ke hāʻawi i nā lawelawe synthesis maʻamau e kūpono i kāu mau pono noiʻi.

Kūkākūkā uku?E hoʻouna mua ʻia ka invoice Proforma ma hope o ka hōʻoia ʻana o ke kauoha, hoʻopili ʻia kā mākou ʻike panakō.Uku e T/T (Telex Transfer), PayPal, Western Union, etc.

103639-04-9 - Pilikia a palekana:

Nā Code Risk
R25 - He ʻawaʻawa inā ʻai ʻia
R36/37/38 - E hoʻonāukiuki i nā maka, ka ʻōpū hanu a me ka ʻili.
Ka wehewehe palekana
S45 - Inā loaʻa ka pōʻino a i ʻole ka maikaʻi ʻole, e ʻimi koke i ka ʻōlelo aʻo kino (e hōʻike i ka lepili inā hiki.)
S37/39 - E hoʻohana i nā mīkina lima kūpono a me ka pale maka/maka
S26 - Inā pili me nā maka, e holoi koke me ka wai nui a e ʻimi i ka ʻōlelo aʻo kino.
Nā ID UN UN 2811 6.1/PG 3
WGK Kelemānia 3
RTECS FE6375500
HS Code 29339900
Papa Hazard 6.1(a)
Hui Pūʻulu II

103639-04-9 - Noi:

ʻO Ondansetron Hydrochloride Dihydrate (CAS: 103639-04-9) kahi mea kūʻē kūʻē i ka serotonin (5-HT3) receptor antagonist.Antiemetic.Hoʻohana ʻia ʻo Ondansetron Hydrochloride Dihydrate no ka pale ʻana i ka nausea a me ka luaʻi i hana ʻia e ka ʻoki ʻana, ka chemotherapy maʻi kanesa, a i ʻole ka mālama ʻana i ka radiation.ʻO ka 5-HT3 receptor antagonists ma Ondansetron nā lāʻau lapaʻau mua i hoʻohana ʻia e mālama a pale i ka nausea a me ka luaʻi i hoʻokomo ʻia i ka chemotherapy a me ka nausea a me ka luaʻi radiotherapy, ma o ka pale ʻana i nā hana o nā kemika i loko o ke kino.ʻOi aku ka maikaʻi ma mua o ka metoclopramide a ʻoi aku ka liʻiliʻi o ka sedating ma mua o ka cyclizine a i ʻole droperidol.Eia naʻe, liʻiliʻi ka hopena o ka luaʻi ma muli o ka maʻi ʻoni.Hiki ke hāʻawi ʻia ma ka waha, ma ke kī ʻia i loko o ka ʻiʻo a i ʻole ka vein.

ʻO Ondansetron a me Granisetron, ʻo Dolasetron ʻekolu mau lāʻau antiemetics maʻamau, ʻo ka ondansetron he serotonin (5-HT3) receptor blocker maikaʻi i hiki ke hoʻololi a koho ʻia, no ka α1, α2, β1, β2-adrenergic receptors a me ka histamine H1, H2 receptors. Loaʻa ka hopena liʻiliʻi, no ka H receptors, waena a me peripheral dopaminergic receptors, ʻaʻohe hopena antagonistic, hiki iā ia ke kāohi i ka chemotherapy a me ka radiotherapy-induced nausea a me ka luaʻi.Hoʻohālikelike ʻia me ka metoclopramide, ʻoi aku ka ikaika o kona hopena antiemetic a ʻaʻohe ona hopena extrapyramidal.No ka luaʻi i hoʻoulu ʻia e cisplatin, cyclophosphamide, doxorubicin, etc. hiki ke hana i ka hopena antiemetic wikiwiki a ikaika.ʻAʻole kūpono ia no ka mālama ʻana i ka nausea a me ka luaʻi i hoʻokumu ʻia e ka cytotoxic chemotherapy a me ka radiation therapy, akā no ka pale ʻana a me ka mālama ʻana i ka nausea a me ka luaʻi i hoʻoiho ʻia e nā ʻoki.Hana ʻo Ondansetron ma ke ʻano he wahi transit ma waena o ke aʻalolo afferent visceral i hoʻāla ʻia i loko o ka ʻōpū o ka ʻōpū a me ka luaʻi ʻana i loko o ke kuamoʻo, kahi e alakaʻi ai i ka diaphragm a me nā ʻiʻo o ka ʻōpū.Hiki i ka chemotherapy a me ka radiation therapy ke hoʻokuʻu i ka ʻōpū 5-HT a hoʻoulu i ke aʻalolo vagus e 5-HT3 receptor, kahi e hoʻoulu ai i ka luaʻi.Hoʻopaʻa kēia huahana i kēia hoʻololi ʻana, i ka manawa like e pale ai i ka luaʻi i hoʻokumu ʻia e ka hana kikowaena.ʻAʻole ʻike ʻia ke ʻano hana e pili ana i ka nausea a me ka luaʻi postoperative.Hiki i ka Ondansetron me ka dexamethasonecan ke hoʻonui i ka hopena anti-emetic.

103639-04-9 - Nā hopena ʻaoʻao:

Hoʻopuka kēia i ka hoʻokuʻu ʻana o ka vagal afferent, hoʻoulu i ka luaʻi.I ka hoʻopaʻa ʻana i nā mea hoʻokipa 5-HT3, hoʻopaʻa ʻo ondansetron i ka hoʻoulu ʻana i ka serotonin, no laila ka luaʻi ʻana, ma hope o nā hoʻoulu emetogenic e like me cisplatin.ʻO ka ʻeha poʻo ka hopena i hōʻike pinepine ʻia o kēia mau lāʻau.

103639-04-9 - Palapala Palekana:

He mea make ma ke ala intravenous.Human systemic effects by intravenous route: jaundice.Ke hoʻomehana ʻia a palaho, hoʻopuka ʻo ia i nā mahu ʻona o NOx.

103639-04-9 - Nā lāʻau lapaʻau holoholona a me nā lāʻau lapaʻau:

Hoʻohana ʻia ma ke ʻano he antiemetic inā ʻaʻole pono nā antiemetics maʻamau, e like me ka hoʻohana ʻana i ka cisplatin a i ʻole nā kumu ʻē aʻe o ka luaʻi intractable.ʻO ka hoʻohana ʻana i ka ondansetron i nā pōpoki he mea hoʻopaʻapaʻa a ʻōlelo kekahi ʻaʻole pono e hoʻohana ʻia i kēia ʻano.

Nā lāʻau lapaʻau ʻO nā pilina pili weliweli me nā lāʻau ʻē aʻe.

103639-04-9 - USP35 maʻamau:

Aia ka Ondansetron Hydrochloride ma lalo o 98.0 pakeneka a ʻaʻole i oi aku ma mua o 102.0 pakeneka o C18H19N3O·HCl, i helu ʻia ma ke kumu anhydrous.

Hoʻopili ʻia a mālama ʻia - mālama ʻia i loko o nā pahu paʻa māmā.E kūʻai ma 25

, ʻae ʻia nā huakaʻi ma waena o 15

a me 30

Nā kūlana hōʻike USP <11>-

USP Ondansetron Hydrochloride RS

USP Ondansetron Huina Pili A RS

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

USP Ondansetron Resolution Mixture RS

ʻO ka Ondansetron hydrochloride e loaʻa ana ma kahi o 0.4% w/w o nā hui ʻelua e pili ana i ka ondansetron A a me 6,6¢-methylene bis-[(1,2,3,9-tetrahydro-9-methyl-3-[(2-methyl-1H-). imidazol-1-yl)-methyl]-4H-carbazol-4-one)]

USP Ondansetron Huina Pili C RS
1,2,3,9-Tetrahydro-9-methyl-4H-carbazol-4-one.

USP Ondansetron Huina Pili D RS
1,2,3,9-Tetrahydro-9-methyl-3-methylene-4H-carbazol-4-one.

ʻike-

A: Infrared Absorption <197M>.

B: E hoʻoheheʻe i 20 mg i 2 mL o ka wai, e hoʻohui i 1 mL o 2 M nitric acid, a kānana: pane ka kānana i ka hoʻāʻo no Chloride <191>.

ʻO ka wai, ke ʻano Ia <921>: ma waena o 9.0% a me 10.5%.

ʻO ke koena ma ka ʻā ʻana <281>: ʻaʻole ʻoi aku ma mua o 0.1%.

Ka palena o ka hui pili ondansetron D-

Māhele Mobile- E hoʻomākaukau i ka hui ʻana o ka 0.02 M monobasic potassium phosphate (i hoʻoponopono mua ʻia me 1 M sodium hydroxide i ka pH o 5.4) a me ka acetonitrile (80:20).Hana i nā hoʻololi inā pono (e nānā i ka System Suitability ma lalo o Chromatography <621>).

ʻO ka hoʻonā maʻamau-E hoʻopau i ka nui o ka USP Ondansetron Related Compound D RS i kaupaona ʻia ma ka pae Mobile, a hoʻoheheʻe ʻia me ka nui, a me ka stepwise inā pono, me ka pae Mobile e loaʻa ai kahi hopena i ʻike ʻia ma kahi o 0.4 µg no mL.

ʻO ka hoʻonā kūpono o ka ʻōnaehana-E hoʻopau i nā nui kūpono o USP Ondansetron Related Compound D RS a me USP Ondansetron Related Compound C RS ma Mobile phase, a dilute quantitatively, a me ka stepwise inā pono, me ka Mobile phase e loaʻa ai kahi hopena i loaʻa ka ʻike ma kahi o 0.6 µg per mL a me 1 µg no ka mL.

Hoʻoholo hoʻāʻo-E hoʻoneʻe ma kahi o 50 mg o Ondansetron Hydrochloride, i kaupaona pololei ʻia, i kahi pahu volumetric 100-mL, hoʻoheheʻe i loko a hoʻoheheʻe ʻia me ka pae Mobile i ka leo, a hui.

Pūnaehana Chromatographic (e nānā i ka Chromatography <621>)-Ua hoʻolako ʻia ka chromatograph wai me kahi mea ʻike 328-nm a me kahi kolamu 4.6-mm × 25-cm i loaʻa iā L10 packing.ʻO ka nui o ke kahe ʻana he 1.5 mL i kēlā me kēia minuke.Chromatograph i ka hoʻonā kūpono Pūnaehana, a hoʻopaʻa i nā pane kiʻekiʻe e like me ke kuhikuhi ʻana no ke Kaʻina Hana: ʻo nā manawa paʻa pili ma kahi o 0.8 no ka hui pili ondansetron C a me 1.0 no ka hui pili ondansetron D;a me ka olelo hooholo, R, mawaena o ka hui pili ondansetron C a me ka hui pili ondansetron D, aole emi malalo o 1.5.Chromatograph the Standard solution, a hoʻopaʻa i nā pane kiʻekiʻe e like me ke kuhikuhi ʻana no ke Kaʻina hana: ʻaʻole i emi iho ka maikaʻi o ke kolamu mai ka piko analyte ma lalo o 400 mau papa theoretical;a ʻo ka ʻokoʻa maʻamau pili no ka hoʻopiʻi hou ʻana ʻaʻole ia ma mua o 2.0%.

Ke Kaʻina Hana- E hoʻokaʻawale i nā puke like (ma kahi o 20 µL) o ka solution Standard a me ka solution Test i loko o ka chromatograph, e hoʻopaʻa i nā chromatograms, a e ana i nā pane no nā piko nui.E helu i ka pākēneka o ka pūhui pili ondansetron D ma ka ʻāpana o ka Ondansetron Hydrochloride i lawe ʻia e ke kumu:

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

i loko o ka C ka manaʻo, i ka mg no mL, o ka USP Ondansetron Related Compound D RS i loko o ka hopena maʻamau;ʻO W ka paona, i ka mg, o Ondansetron Hydrochloride i lawe ʻia no ka hoʻomākaukau ʻana i ka hopena hoʻāʻo;a ʻo rU a me rS nā ʻāpana kiʻekiʻe i loaʻa mai ka hoʻonā hoʻāʻo a me ka hoʻonā maʻamau, kēlā me kēia: ʻaʻole i ʻoi aku ma mua o 0.10% i loaʻa.

Chromatographic maemae-

ʻano i-

Hoʻoholo hoʻonā-Hoʻoheheʻe i ka nui o USP Ondansetron Resolution Mixture RS i loko o ka methanol, a hoʻoheheʻe ʻia me ka nui, a me ka stepwise inā pono, me ka methanol e loaʻa ai kahi hopena i ʻike ʻia he 12.5 mg no ka mL.

Nā hāʻina maʻamau-E hoʻoheheʻe i ka nui o ka USP Ondansetron Hydrochloride RS i kaupaona pono ʻia i loko o ka methanol, a hui ʻia e loaʻa ka hopena i ʻike ʻia ma kahi o 0.25 mg no ka mL.E hoʻoheheʻe nui ʻia kēia hāʻina me ka methanol no ka loaʻa ʻana o nā hāmeʻa maʻamau, i kuhikuhi ʻia ma lalo nei e ka leka, me nā haku mele penei:

Haʻina maʻamau	Dilution	Hoʻopaʻa (µg RS no mL)	Pākēneka (%, no ka hoʻohālikelike ʻana me ka hōʻike hōʻike)
A	(1 i 5)	50	0.4
B	(1 i 10)	25	0.2
C	(1 i 20)	12.5	0.1

Hoʻonā hoʻāʻo-E hoʻoheheʻe i ka nui o ka Ondansetron Hydrochloride i kaupaona pono ʻia i loko o ka methanol e loaʻa ai kahi hopena i loaʻa ka 12.5 mg no ka mL.Ke Kaʻina Hana-E hoʻokaʻawale i 20 µL o ka hoʻonā hoʻāʻo, 20 µL o kēlā me kēia hāmeʻa maʻamau, a me 20 µL o ka solution Resolution i kahi pā chromatographic ʻāpana lahilahi (e nānā i ka Chromatography621) i uhi ʻia me kahi ʻāpana 0.25-mm o ka huila silica gel chromatographic.E hoʻomohala i ka chromatogram i loko o kahi ʻōnaehana hoʻoheheʻe i hui pū ʻia me ka chloroform, ethyl acetate, methanol, a me ammonium hydroxide (90:50:40:1) a hiki i ka neʻe ʻana o ka ʻūhā mua ma kahi o ʻekolu hapahā o ka lōʻihi o ka pā.Wehe i ka pā mai ke keʻena, e kaha i ka mea hoʻoheheʻe i mua, a ʻae i ka mea hoʻoheheʻe e mahu.E noʻonoʻo i ka pā ma lalo o ke kukui UV pōkole-lōʻihi: loaʻa ka hoʻonā piha o nā ʻāpana ʻekolu o ka wahi hoʻonā Resolution.E hoʻohālikelike i ka ikaika o nā kiko lua i ʻike ʻia i loko o ka chromatogram o ka ho'āʻo ho'āʻo me nā kiko nui o nā chromatograms o nā hāmeʻa maʻamau: ʻo kēlā me kēia wahi lua mai ka chromatogram o ka hoʻonā ho'āʻo me ka waiwai RF e pili ana i ko ke kula kiʻekiʻe. ʻaʻole ʻoi aku ka nui a ʻoi aku ka ikaika o ka wahi o ka solution Resolution ma mua o ka wahi nui i loaʻa mai ka solution Standard A (0.4%);ʻaʻohe wahi lua ʻē aʻe mai ka chromatogram o ka solution Test i ʻoi aku ka nui a i ʻole ka ikaika ma mua o ka wahi kumu i loaʻa mai ka solution maʻamau B (0.2%).

ʻano ii-

ʻO ka pae kelepona a me ka ʻōnaehana Chromatographic-E hoʻomau e like me ke kuhikuhi ʻana ma ka Assay.

Haʻina maʻamau-E hoʻomau e like me ke kuhikuhi ʻana no ka hoʻomākaukau maʻamau i ka Assay.

Hoʻoholo hoʻāʻo-E hoʻohana i ka hoʻomākaukau Assay.

Kaʻina hana-Hoʻokaʻawale i nā puke like (e pili ana i 10 µL) o ka solution Standard a me ka solution Test i loko o ka chromatograph, hoʻopaʻa i nā chromatograms, a ana i nā pane kiʻekiʻe.E helu i ka pākēneka o kēlā me kēia haumia i ka ʻāpana o ka Ondansetron Hydrochloride i lawe ʻia e ke kumu:

50,000(C/W)(1/F)(ri / rS)
i loko o ka C ka mana'o, ma ka mg no mL, o ka USP Ondansetron Hydrochloride RS i ka ho'onā ma'amau;ʻO W ka paona, i ka mg, o Ondansetron Hydrochloride i lawe ʻia no ka hoʻomākaukau ʻana i ka hopena hoʻāʻo;ʻO F ke kumu pane pili o nā haumia e like me ka mea i wehewehe ʻia ma ka papa ʻaina;ʻO ri ka wahi kiʻekiʻe no kēlā me kēia haumia i loko o ka hoʻonā Ho'āʻo;a ʻo rS ka ʻāpana kiʻekiʻe o ka ondansetron i loaʻa mai ka hopena maʻamau: kūpono ia i nā koi i hāʻawi ʻia ma ka papaʻaina.

Inoa Huihui	Manawa Paa Pilina	Hoahanau Pane Kumukumu	palena (%)
Ondansetron pili pūhui C	ma kahi o 0.32	1.2	0.2
ʻO ka hui pili o Ondansetron D*	ma kahi o 0.34	—	0.1
Imidazole	ma kahi o 0.49	0.3	0.2
2-methylimidazole	ma kahi o 0.54	0.4	0.2
Ondansetron	1.0	—	—
Ondansetron pili pūhui A	ma kahi o 1.10	0.8	0.2
ʻAʻole ʻike ʻia	—	1.0	0.1
Huina	—	—	0.5
* Hoʻohālikelike ʻia i ka hoʻāʻo no ka palena o ka hui pili ondansetron D.

hoʻāʻo-

Māhele Mobile-E hoʻomākaukau i ka hui ʻana i kānana a hoʻoheheʻe ʻia o 0.02 M monobasic sodium phosphate (i hoʻoponopono mua ʻia me 1 M sodium hydroxide i kahi pH o 5.4) a me ka acetonitrile (50:50).Hana i nā hoʻololi inā pono (e nānā i ka System Suitability ma lalo o Chromatography <621>).

Hoʻomākaukau maʻamau-E hoʻoheheʻe i ka nui o ka USP Ondansetron Hydrochloride RS i kaupaona pono ʻia ma ka pae Mobile, a hoʻoheheʻe ʻia me ka nui, a me ka stepwise inā pono, me ka pae Mobile e loaʻa ai kahi hopena i ʻike ʻia ma kahi o 90 µg no mL.

ʻO ka hopena kūpono o ka ʻōnaehana-E hoʻopau i nā nui kūpono o USP Ondansetron Hydrochloride RS a me USP Ondansetron Related Compound A RS ma ka pae Mobile, a hoʻoheheʻe ʻia me ka nui, a me ka stepwise inā pono, me ka pae Mobile e loaʻa ai kahi hopena e pili ana i 90 µg no mL a me 20 µg no mL , pakahi.

Hoʻomākaukau hoʻāʻo-E hoʻoneʻe e pili ana i 45 mg o Ondansetron Hydrochloride, i kaupaona pololei ʻia, i kahi pahu volumetric 50-mL, hoʻoheheʻe i loko a hoʻoheheʻe ʻia me ka pae Mobile i ka leo, a hui.Pipet 5.0 mL o kēia hoʻonā i loko o ka ipu volumetric 50-mL, e hoʻoheheʻe me ka pae Mobile i ka leo, a hui.

Pūnaehana Chromatographic (e nānā i ka Chromatography <621>)-Ua hoʻolako ʻia ka chromatograph wai me kahi mea ʻike 216-nm a me kahi kolamu 4.6-mm × 25-cm i loaʻa iā L10 packing.ʻO ka nui o ke kahe ʻana he 1.5 mL i kēlā me kēia minuke.Chromatograph i ka hoʻonā kūpono Pūnaehana, a hoʻopaʻa i nā pane kiʻekiʻe e like me ke kuhikuhi ʻana no ke Kaʻina Hana: ʻo nā manawa paʻa pili ma kahi o 1.0 no ka ondansetron a me 1.1 no ka hui pili ondansetron A;a ʻo ka ʻōlelo hoʻoholo, R, ma waena o ka hui pili ondansetron A me ka ondansetron ʻaʻole i emi iho ma mua o 1.5.Chromatograph i ka hoʻomākaukau maʻamau, a hoʻopaʻa i nā pane kiʻekiʻe e like me ke kuhikuhi ʻana no ke Kaʻina Hana: ʻaʻole ʻoi aku ka nui o ka huelo ma mua o 2.0;a ʻo ka ʻokoʻa maʻamau pili no ka hoʻopili hou ʻana ʻaʻole i ʻoi aku ma mua o 1.5%.

Kaʻina hana-Hoʻokaʻawale i nā puke like (ma kahi o 10 µL) o ka hoʻomākaukau maʻamau a me ka hoʻomākaukau ʻana i ka Assay i loko o ka chromatograph, e hoʻopaʻa i nā chromatograms, a ana i nā pane no nā piko nui.E helu i ka nui, ma mg, o C18H19N3O·HCl i loko o ka hapa o Ondansetron Hydrochloride i lawe ʻia e ke kumu:

500C(rU / rS)
i loko o ka C ka hoʻopaʻa ʻana, i ka mg per mL, o USP Ondansetron Hydrochloride RS i ka hoʻomākaukau maʻamau;a ʻo rU a me rS nā wahi kiʻekiʻe i loaʻa mai ka hoʻomākaukau Assay a me ka hoʻomākaukau maʻamau.

103639-04-9 - Hana Hana:

Hana 1: Ma hope o ka hopena o 2-Bromoaniline a me1,3-Cyclohexanedione, Hoʻokumuʻia ka derivative tetrahydrocarbazole, a loaʻa ka pūhui (III) ma ka hanaʻana me ka dimethylamine a me ka diformaldehyde, a me ka hoʻokomoʻana i ka dimethylaminomethyl ma ke kūlana 2.3.80G o ka pūhui (III) ua hoʻopili ʻia me ka methyl iodide e hāʻawi i 5.72g o ka pūhui (IV) ma ka quaternizing i ka hui amino kaulahao ʻaoʻao me ka hoʻokomo ʻana i ka pūʻulu methyl ma ke kūlana 9. 2.0g o ka hui (IV) a me 2-methyl-1h -imidazole ua hana ʻia i ka dimethylformamide me ka hoʻoulu ʻana ma 95 ℃.No ka loaʻa ʻana o 0.60G o Ondansetron.

Hana 2: Ua hāʻawi ka hopena o cyclohexanone a me phenylhydrazine i ka tetrahydrocarbazole ma 85% hua.E hoʻoheheʻe iā ia i loko o ka tetrahydrofuran a me ka wai, e hoʻohui i ka 2,3 Dropwise ma 0 °c i ka nitrogen, Ua hoʻoulu ʻia kahi hopena o 5, 6-tetrachloro-1,4-benzoquinone i ka tetrahydrofuran e hāʻawi i ka huahana oxidation (II) i 67.4% hua.Huina (II), ethanol, concentrated hydrochloric acid, paraformaldehyde a me dimethylamine hydrochloride i refluxed pu.Ma hope o ka mālama ʻana, loaʻa ka huahana (V) ma ka hoʻohui ʻana i ka waika hydrochloric concentrated i ka acetone a me ka hoʻoulu ʻana i 50 ℃.I ka 71.7% hua.Hoʻopili ʻia ka hui (V) a me 2-methylimidazole i ka wai ma 110 ℃.No ka loaʻa ʻana o ka pūhui (VI) ma 70.9% hua.Hoʻoulu ʻia ka hui (VI), methyl iodide a me ka potassium carbonate ma ka lumi wela a nalowale ka paʻa.Ua ninini ʻia i loko o ka wai, hoʻoulu ʻia, kānana, holoi ʻia me ka wai, a hana hou ʻia mai ka methanol e loaʻa ai ka ondansetron i ka 57.2% yield.E hoʻoheheʻe iā ia i loko o kahi hui o ka acetone a me ka wai, Ma ka hoʻohui ʻana i ka waika hydrochloric concentrated i ka hopena, ua loaʻa ka ondansetron hydrochloride dihydrate me ka hua o 92.6%.

Keʻano 3: hoʻoulu ʻia ka hui (II), ka pālolo pālolo, ka acetone a me ka dimethyl sulfate i ka lumi wela.Ua loaʻa ka hui (VII) i kahi hua o 91%.Ua hoʻoheheʻe ʻia ka hui (VII) i loko o ka ethanol a ua hoʻohui ʻia ka hui ʻana o ka paraformaldehyde kanaka a me ka dimethylamine hydrochloride i nā ʻāpana ma lalo o ka reflux.ʻO ka hoʻihoʻi ʻana.Ma hope o ka lapaʻau ʻana, loaʻa ka hui (VIII) i 67% hua.(Viii) hoʻoheheʻe ʻia i loko o ka ethanol anhydrous, hydrogen chloride gas, kona hydrochloride.Hoʻohui ʻia ka hydrochloride i ka wai a hoʻohui ʻia ka 2 ma 50 ℃.Methylimidazole, refluxing ondansetron, hua 70%.Ua hoʻoheheʻe ʻia i loko o ka isopropanol, ka wai a me ka waikawa hydrochloric concentrated, a hoʻoulu ʻia ma ka lumi wela e loaʻa ai ka ondansetron hydrochloride dihydrate i ka hua o 90.5%.