I-Gemcitabine Hydrochloride CAS 122111-03-9 API USP35 Isithombe Esifakiwe Esijwayelekile

I-Gemcitabine Hydrochloride CAS 122111-03-9 API USP35 Standard

Incazelo emfushane:

Igama Lekhemikhali: Gemcitabine Hydrochloride

I-CAS: 122111-03-9

Ukubukeka: I-Crystalline Powder Emhlophe, Ayinaphunga

I-Assay: 97.5%~101.5% (Ibalwa Ngesisekelo Esomisiwe)

I-API USP Standard, Ukukhiqiza Kwezentengiso

Thintana: UDkt. Alvin Huang

Iselula/Wechat/WhatsApp: +86-15026746401

E-Mail: alvin@ruifuchem.com

Thumela i-imeyili kithi

Imininingwane Yomkhiqizo

Imikhiqizo Ehlobene

Omaka bomkhiqizo

122111-03-9 - Incazelo:

I-Ruifu Chemical ingumkhiqizi ohamba phambili we-Gemcitabine Hydrochloride (CAS: 122111-03-9) enekhwalithi ephezulu, ukukhiqizwa kwezohwebo.I-Ruifu Chemical inganikeza ukulethwa komhlaba wonke, intengo encintisanayo, isevisi enhle kakhulu, amanani amancane kanye nenqwaba etholakalayo.Thenga iGemcitabine Hydrochloride,Please contact: alvin@ruifuchem.com

122111-03-9 -Chemical Properties:

Igama Lekhemikhali	IGemcitabine Hydrochloride
Omqondofana	I-Gemcitabine HCl;2'-Deoxy-2',2'-Difluorocytidine Hydrochloride;I-dFdC;dFdCyd;I-Gemzar;I-LY188011 Hydrochloride;I-Gemcitera;I-Gemsar
Inombolo ye-CAS	122111-03-9
I-CAS ehlobene	95058-81-4 - Isisekelo samahhala
Isimo Sesitoko	Esitokweni, Amandla Okukhiqiza Amathani angu-5
I-Molecular Formula	I-C9H12ClF2N3O4
Isisindo samangqamuzana	299.66
I-Melting Point	>250℃
Isimo Sokuthumela	Ngaphansi Kwezinga Lokushisa Le-Ambient
I-COA ne-MSDS	Iyatholakala
Umsuka	Shanghai, China
Ibhrendi	I-Ruifu Chemical

122111-03-9 -Imininingwane:

Into	Imininingwane	Imiphumela
Ukubukeka	I-Crystalline Powder Emhlophe, Ayinaphunga	Iyahambisana
Ukuncibilika	Incibilika Emanzini, incibilika kancane ku-methanol, ayincibiliki ku-acetone	Iyahambisana
Ukuhlonza IR	I-spectrum ye-IR kufanele ihambisane nayo lokho kwezinga lokubhekisela	Iyahambisana
Ukuhlonza I-Chloride	Okuhle.Ihlangabezana nezidingo zokuhlolwa kwe-chloride	Iyahambisana
Ukubukeka Kwesixazululo	Isixazululo S ngokusobala futhi hhayi kakhulu isixazululo esinemibala kunereferensi BY7	Iyahambisana
pH	2.0~3.0	2.6
Ukuzungezisa Okuthile [α]20/D	+43.0° ukuze +50.0°	+47.5°
Izinsimbi Ezisindayo (Pb)	≤10ppm	<10ppm
Ukulahlekelwa Ekumisweni	≤1.00%	0.3%
Izinsalela ekushiseni	≤0.10%	0.03%
Izinto Ezihlobene
I-Cytosine	≤0.10%	0.01%
α-Isomer	≤0.10%	0.01%
Noma Ikuphi Okunye Ukungcola	≤0.10%	0.04%
Ukungcola Okuphelele	≤0.20%	0.1%
Izincibilikisi Ezisele
I-Methanol	≤0.30%	Akutholwanga
I-Toluene	≤0.01%	Akutholwanga
I-Dichloromethane	≤0.01%	Akutholwanga
I-acetone	≤0.50%	0.1%
Isivivinyo	97.5%~101.5% (Ibalwe Ngesisekelo Esomisiwe)	99.9%
Isiphetho	Ivumelana ne-USP35 Standard

Iphakheji/Isitoreji/Ukuthumela ngomkhumbi:

Iphakheji:Ibhodlela, isikhwama se-Aluminium foil, 25kg/Cardboard Drum, noma ngokwezidingo zekhasimende.
Isimo Sesitoreji:Gcina isitsha sivalwe ngokuqinile futhi usigcine endaweni epholile, eyomile futhi enomoya omuhle kude nezinto ezingahambelani.Gwema ukuchayeka elangeni eliqondile, umswakama kanye nokushisa ngokweqile.
Ukuthumela:Zilethe emhlabeni wonke ngendiza, yi-FedEx/DHL Express.Nikeza ukulethwa okusheshayo nokuthembekile.

Izinzuzo:

I-FAQ:

122111-03-9 - Ubungozi Nokuphepha:

Amakhodi Engozi R21 - Kuyingozi ukuthintana nesikhumba
R36/38 - Ukucasula emehlweni nasesikhumbeni.
R46 - Ingadala ukulimala kofuzo
I-R62 - Ingozi engaba khona yokukhubazeka kokuzala
R63 - Ingozi engaba khona yokulimala enganeni engakazalwa
Incazelo Yezokuphepha S25 - Gwema ukuthintana namehlo.
S26 - Uma uthintana namehlo, geza ngokushesha ngamanzi amaningi futhi ufune iseluleko sezokwelapha.
I-S36/37 - Gqoka izingubo zokuzivikela ezifanele namagilavu.
I-S53 - Gwema ukuchayeka - thola imiyalelo ekhethekile ngaphambi kokusetshenziswa.
I-WGK Germany 3
I-RTECS HA3840000
I-HS Code 2942000000

122111-03-9 -Isicelo:

I-Gemcitabine Hydrochloride (i-CAS: 122111-03-9) iyinoveli yokwenziwa yesidakamizwa i-difluoro nucleoside anti-metabolic kanye ne-antineoplastic.Icwaningwa futhi yathuthukiswa yi-Eli Lilly and Company futhi yagunyazwa ukuthi ifakwe ohlwini eNingizimu Afrika, eSweden, eNetherlands, e-Australia nakwamanye amazwe ngo-1995. I-United States Food and Drug Administration (FDA) yagunyaza njengokwelashwa komugqa wokuqala. yokwelashwa komdlavuza wamaphaphu ongewona omncane kanye nomdlavuza wamaphaphu.
Eminyakeni yamuva, izidakamizwa ezintsha ezifana ne-Gemcitabine, i-Paclitaxel, i-Docetaxel, i-Vinorebine ziyizidakamizwa ezisebenzayo zokwelapha umdlavuza wamaphaphu ongewona omncane (efushanisiwe i-NSCLC).Uma kuqhathaniswa nemithi yendabuko ye-chemotherapy, le mithi inezinzuzo zomphumela ophezulu wokwelapha kanye nobuthi obuphansi.I-Gemcitabine Hydrochloride isizukulwane esisha sesidakamizwa esilwa nama-metabolites kanye nohlobo lomuthi okhethekile womjikelezo weseli, odlala indima enkulu esigabeni sokuhlanganiswa kwe-DNA, okuyisigaba sika-S samaseli.Ngaphansi kwezimo ezithile, lo muthi ungavimbela ukuqhubeka kwamaseli ukusuka esigabeni se-G1 ukuya esigabeni sika-S, futhi ube nomsebenzi oqinile wokulwa nomdlavuza okungewona omncane wengqamuzana lomdlavuza wamaphaphu (NSCLC).Ucwaningo lwangaphandle lubonise ukuthi ukusebenza kahle kokwelashwa okukodwa kwe-NSCLC nge-Gemcitabine Hydrochloride kuphela cishe ku-18%~35%, kuyilapho kuhlanganiswa ukwelashwa ne-cisplatin ukusebenza kahle kwe-NSCLC kungu-41.7%.Ku-NSCLC ethuthukisiwe, izinga elisebenzayo le-carboplatin liyi-16%, elifana ne-cisplatin, kodwa linobuthi obuphansi, ikakhulukazi ekuphenduleni kwamathumbu, ukucindezelwa komnkantsha kanye nokusabela okunobuthi kwezinso nezinzwa.Ngokuhlanganiswa ne-carboplatin, zombili zinokuxhumana okuhambisanayo kanye nomphumela wokungeza, futhi zingakhiqiza imiphumela ephezulu yokwelapha.

122111-03-9 -I-USP35 Standard:

IGemcitabine Hydrochloride
C9H11F2N3O4·HCl 299.66
I-Cytidine, i-2′-deoxy-2′,2′-difluro-, i-monohydrochloride.
I-2′-Deoxy-2′,2′-difluorocytidine monohydrochloride (β-isomer) [122111-03-9].
» I-Gemcitabine Hydrochloride iqukethe amaphesenti angekho ngaphansi kwamaphesenti angama-97.5 futhi angabi ngaphezu kwamaphesenti angu-101.5 we-C9H11F2N3O4·HCl, abalwe ngokwesisekelo sokuthi uyikho.
[Isixwayiso-Gemcitabine Hydrochloride i-ejenti enamandla ye-cytotoxic.Kufanele kuqashelwe kakhulu ukuvimbela ukuhogela izinhlayiya nokubeka isikhumba kuso.]
Ukupakisha nokugcina-Londoloza ezitsheni eziqinile.
Ukulebula-Lapho ihloselwe ukusetshenziswa ekulungiseni amafomu emithamo yomjovo, ilebula ithi ayinyumba noma kufanele iqhubeke nokucutshungulwa ngesikhathi sokulungiswa kwamafomu okujovwa.
Amazinga ereferensi we-USP <11>-
USP Cytosine RS
USP Endotoxin RS
USP Gemcitabine Hydrochloride RS
Ukuhlonza-
A: I-Infrared Absorption <197K>.
B: Ihlangabezana nezimfuneko zokuhlolwa kweChloride <191>.
Ukuzungezisa okuqondile <781S>: phakathi kuka-+43 kanye no-+50, ngo-20.
Isixazululo sokuhlola: 10 mg ngemL.
i-pH <791>: phakathi kuka-2.0 no-3.0, esixazululweni esiqukethe u-10 mg ngemL ngayinye.
Izinsalela ekushiseni <281>: hhayi ngaphezu kuka-0.1%.
Izinsimbi ezinzima, Indlela I <231>: 0.001%.
Ubumsulwa beChromatographic-
Isixazululo A- Qhubeka njengoba kuqondiswe esigabeni Seselula ku-Assay.
Isixazululo B-Lungiselela i-methanol ehlungiwe futhi ekhishwe umoya.
Isigaba seselula-Sebenzisa izingxube eziguquguqukayo zesixazululo A nesixazululo B njengoba kuqondiswe ngaphansi kwesistimu ye-Chromatographic.Yenza izinguquko, uma kudingeka (bona Ukufaneleka Kwesistimu ngaphansi kwe-Chromatography 621).
Isixazululo sokufaneleka kwesistimu-Qhubeka njengoba kuqondiswe ku-Assay.
Isixazululo esijwayelekile-Chaza isamba esikalwe ngokunembile se-USP Gemcitabine Hydrochloride RS kanye ne-USP Cytosine RS emanzini, futhi uhlambulule ngobuningi, nangesinyathelo uma kudingeka, ukuze uthole isixazululo esinokugxila okwaziwayo okungaba ngu-2 µg ngemL ngayinye.
Isixazululo sokuhlola-Dlulisa cishe u-50 mg we-Gemcitabine Hydrochloride, ukalwe ngokunembile, uye ku-25-mL ye-volumetric flask, hlakazeka futhi uhlambulule ngamanzi ukuya kuvolumu, bese uxuba.
Isistimu ye-Chromatographic (bona i-Chromatography 621) -Qhubeka njengoba kuqondiswe ngaphansi kwe-Assay.Ichromatograph ihlelwe kanje.
Isikhathi (imizuzu) Isixazululo A (%) Isixazululo B (%) Ukulinganisa
0–8 97 3 isokhrasi
8–13 97®50 3®50 i-gradient yomugqa
13–20 50 50 isokhrasi
20–25 50®97 50®3 ukulinganisa kabusha
I-Chromatograph isixazululo sokufaneleka Kwesistimu, futhi urekhode izimpendulo eziphezulu njengoba kuqondiswe kuNqubo: izikhathi zokugcinwa okuhlobene zicishe zibe ngu-0.5 we-gemcitabine -anomer kanye no-1.0 we-gemcitabine;isixazululo, R, phakathi kwe-gemcitabine -anomer ne-gemcitabine ayikho ngaphansi kuka-8.0;futhi isici somsila we-gemcitabine asidluli ku-1.5.I-Chromatograph isisombululo Esijwayelekile, futhi urekhode izimpendulo eziphezulu njengoba kuqondiswe kuNqubo: izikhathi zokugcinwa okuhlobene zicishe zibe ngu-0.1 ku-cytosine kanye no-1.0 kwe-gemcitabine;ukuchezuka okujwayelekile okuhlobene kwemijovo eyimpinda akukho ngaphezu kuka-2.0%.
Inqubo-Jonga ngokuhlukile umthamo (cishe u-20 µL) wesisombululo Esijwayelekile nesixazululo sokuhlola ku-chromatograph, rekhoda i-chromatogram, futhi ulinganise zonke izimpendulo eziphezulu.Bala iphesenti le-cytosine engxenyeni ye-Gemcitabine ethathwe ifomula:
2.5(Cc / W)(rt / rs)
lapho i-Cc iwukugxila kwe-USP Cytosine RS kusixazululo Esijwayelekile, ngo-µg ngemL ngayinye;W yisisindo, ngo-mg, seGemcitabine esithathiwe;rt impendulo ephezulu ye-cytosine kusixazululo sokuhlola;futhi i-rs iyimpendulo ye-cytosine kusixazululo Esijwayelekile: akutholakali ngaphezu kuka-0.1% we-cytosine.Bala iphesenti lokungcola ngakunye ngaphandle kwe-cytosine engxenyeni ye-Gemcitabine ethathwe ifomula:
2.5(Cs / W)(ri / rs)
lapho i-Cs iwukugxila kwe-USP Gemcitabine Hydrochloride RS kusixazululo Esijwayelekile, ngo-µg ngemL;W yisisindo, ngo-mg, seGemcitabine esithathiwe;i-ri iyimpendulo ephakeme kakhulu yokungcola ngakunye kusixazululo sokuhlola;futhi i-rs iyimpendulo ngenxa ye-gemcitabine kusixazululo Esijwayelekile: akutholakali ngaphezu kuka-0.1% we-gemcitabine -anomer noma okunye ukungcola komuntu ngamunye;futhi isamba sakho konke ukungcola asikho ngaphezu kuka-0.2%.Khipha esibalweni sakho konke ukungcola noma yiziphi iziqongo ezingaphansi komkhawulo wenani (0.02%).
Ezinye izimfuneko-Lapho ilebula ithi i-Gemcitabine Hydrochloride iyinyumba, ihlangabezana nezimfuneko ze-bacterial endotoxins kanye ne-Sterility ngaphansi kwe-Gemcitabine Yomjovo.Lapho ilebula ithi i-Gemcitabine Hydrochloride kumele iqhubeke nokucutshungulwa ngesikhathi sokulungiswa kwamafomu omthamo omjovo, ihlangabezana nezimfuneko zama-endotoxin Ebhaktheriya ngaphansi kwe-Gemcitabine Yomjovo.
Isivivinyo-
Isigaba seselula-Lungiselela isixazululo esihlungiwe nesincishiwe esiqukethe u-13.8 g we-monobasic sodium phosphate kanye no-2.5 mL we-phosphoric acid ku-1000 mL wamanzi.[Qaphela-I-pH yalesi sixazululo iphakathi kuka-2.4 no-2.6.]
Isixazululo sokufaneleka kwesistimu-Dlulisa mayelana ne-10 mg ye-Gemcitabine Hydrochloride ku-vial encane, engeza i-4 mL yesisombululo esiqukethe i-168 mg ye-potassium hydroxide nge-mL ye-methanol, i-cap tightly, ne-sonicate.Shisisa ku-55 amahora angu-6 kuya kwangu-16, vumela ukuthi kuphole, futhi udlulisele okuqukethwe ku-100-mL ye-volumetric flask ngokuwasha okulandelanayo kwe-1% (v/v) ye-phosphoric acid.Nciphisa nge-1% phosphoric acid kuvolumu, bese uxuba.[Qaphela-Lesi sixazululo siqukethe cishe u-0.02 mg ngemL ngayinye ye-gemcitabine α-anomer.]
Ukulungiselela okujwayelekile-Chaza isamba esikalwe ngokunembile se-USP Gemcitabine Hydrochloride RS emanzini, futhi uhlambulule ngobuningi, futhi ngokwesinyathelo uma kunesidingo, ngamanzi ukuze uthole isixazululo esinokugxila okwaziwayo okungaba ngu-0.1 mg nge-mL ngayinye.
Ukulungiswa kwe-Assay-Dlulisa cishe u-20 mg we-Gemcitabine Hydrochloride, ukalwe ngokunembile, ku-200-mL ye-volumetric flask, ncibilika futhi uhlambulule ngamanzi ukuya kuvolumu, bese uxuba.
Isistimu ye-Chromatographic (bona i-Chromatography <621>)-I-chromatograph ewuketshezi ifakwe umtshina ongu-275-nm kanye nekholomu engu-4.6-mm × 25-cm equkethe 5-µm ukupakisha L7.Izinga lokugeleza licishe libe ngu-1.2 mL ngomzuzu.I-Chromatograph isixazululo sokufaneleka kweSistimu, futhi urekhode izimpendulo eziphezulu njengoba kuqondiswe kuNqubo: isixazululo, R, phakathi kwe-gemcitabine -anomer ne-gemcitabine ayikho ngaphansi kuka-8.0;futhi isici somsila esinqunywe ku-gemcitabine asidluli ku-1.5.I-Chromatograph ukulungiselelwa Okujwayelekile, futhi urekhode izimpendulo eziphezulu njengoba kuqondiswe kuNqubo: ukuchezuka okujwayelekile okuhlobene kwemijovo eyimpinda akukho ngaphezu kuka-1.0%.
Inqubo-Ngokuhlukile jova amavolumu alinganayo (cishe u-20 µL) wokulungiselela Okujwayelekile kanye nokulungiswa kwe-Assay ku-chromatograph, rekhoda ama-chromatogram, futhi ulinganise izimpendulo zeziqongo ezinkulu.Bala inani, ngo-mg, le-C9H11F2N3O4·HCl engxenyeni ye-Gemcitabine Hydrochloride ethathwe ifomula:
200C(rU / rS)
lapho u-C ewukugxila, ngo-mg nge-mL ngayinye, ye-USP Gemcitabine Hydrochloride RS ekulungiseleleni Okujwayelekile;futhi i-rU kanye ne-rS yizimpendulo eziphezulu ezitholakala ekulungiselelweni kwe-Assay nasekulungiseleleni Okujwayelekile, ngokulandelanayo.