Gemcitabine Hydrochloride CAS 122111-03-9 API USP35 Standard

Tlhaloso e Khutšoanyane:

Lebitso la lik'hemik'hale: Gemcitabine Hydrochloride

CAS: 122111-03-9

Ponahalo: Phofo e tšoeu ea Crystalline, e sa nkheng

Tekanyetso: 97.5%~101.5% (E baloa ka Motheo o Omisitsoeng)

API USP Standard, Tlhahiso ea Khoebo

Ikopanye le: Dr. Alvin Huang

Mobile/Wechat/WhatsApp: +86-15026746401

E-Mail: alvin@ruifuchem.com

Re romelle lengolo-tsoibila

Lintlha tsa Sehlahisoa

Lihlahisoa tse Amanang

Li-tag tsa Sehlahisoa

122111-03-9 - Tlhaloso:

Ruifu Chemical ke moetsi ea ka sehloohong oa Gemcitabine Hydrochloride (CAS: 122111-03-9) e nang le boleng bo phahameng, tlhahiso ea khoebo.Ruifu Chemical e ka fana ka lits'ebeletso tsa lefats'e ka bophara, theko ea tlholisano, litšebeletso tse ntle haholo, tse nyane le tse ngata tse fumanehang.Reka Gemcitabine Hydrochloride,Please contact: alvin@ruifuchem.com

122111-03-9 -Lintho tsa Lik'hemik'hale:

Lebitso la Lik'hemik'hale	Gemcitabine Hydrochloride
Litlhaloso tse tšoanang	Gemcitabine HCl;2'-Deoxy-2', 2'-Difluorocytidine Hydrochloride;dFdC;dFdCyd;Gemzar;LY188011 Hydrochloride;Gemcitera;Gemsar
Nomoro ea CAS	122111-03-9
CAS e amanang le eona	95058-81-4 - Motheo oa Mahala
Boemo ba Setoko	Ka Setokong, Bokhoni ba Tlhahiso 5 Tons
Foromo ea limolek'hule	C9H12ClF2N3O4
Boima ba Molek'hule	299.66
Melting Point	>250℃
Boemo ba ho Romela	Tlas'a Mocheso oa Ambient
COA & MSDS	E fumaneha
Tšimoloho	Shanghai, China
Brand	Ruifu Chemical

122111-03-9 -Litlhaloso:

Ntho	Litlhaloso	Liphetho
Ponahalo	Phofo e Tšoeu ea Crystalline, e sa nkheng	E lumellana
Solubility	E qhibiliha ka metsing, e qhibiliha hanyenyane ka methanol, hoo e batlang e sa qhibilihe ka har'a acetone	E lumellana
Boitsebiso ba IR	IR spectrum e lokela ho lumellana le ea tekanyetso ea litšupiso	E lumellana
Ho khetholla Chloride	E ntle.E kopana le litlhoko tsa liteko tsa chloride	E lumellana
Ponahalo ea Tharollo	Tharollo S ka ho hlaka eseng ka matla ho feta mebala ho feta tharollo ea litšupiso BY7	E lumellana
pH	2.0~3.0	2.6
Potoloho e Khethehileng [α]20/D	+43.0 ° ho ea ho +50.0 °	+47,5°
Litšepe tse boima (Pb)	≤10ppm	<10ppm
Tahlehelo ka ho Omisa	≤1.00%	0.3%
Masalla a ho Ignition	≤0.10%	0.03%
Lintho Tse Amanang
Cytosine	≤0.10%	0.01%
α-Isomer	≤0.10%	0.01%
Tšilafalo E 'ngoe	≤0.10%	0.04%
Litšila ka Kakaretso	≤0.20%	0.1%
Metsoako e setseng
Methanol	≤0.30%	Ha e fumanwe
Toluene	≤0.01%	Ha e fumanwe
Dichloromethane	≤0.01%	Ha e fumanwe
Acetone	≤0.50%	0.1%
Tlhahlobo	97.5%~101.5% (E baloa ka Motheo o Omisitsoeng)	99.9%
Qetello	E lumellana le USP35 Standard

Sephutheloana/Bobolokelo/Ho tsamaisa ka sekepe:

Sephutheloana:Botlolo, Aluminium foil bag, 25kg/Cardboard Drum, kapa ho ea ka tlhokahalo ea moreki.
Boemo ba polokelo:Boloka setshelo se koetsoe ka thata 'me u se boloke sebakeng sa polokelo se pholileng, se omeletseng le se nang le moea o motle hole le lintho tse sa lumellaneng.Qoba ho pepesehela letsatsi le tobileng, mongobo le mocheso o feteletseng.
Ho tsamaisa ka sekepe:Tsamaisa lefatšeng ka bophara ka sefofane, ka FedEx / DHL Express.Fana ka thomello e potlakileng le e tšepahalang.

Melemo:

LBH:

122111-03-9 - Kotsi le Tšireletseho:

Likhoutu tsa Kotsi R21 - E kotsi ha u kopana le letlalo
R36/38 - Ho tena mahlo le letlalo.
R46 - E ka baka tshenyo ya lefutso le lefutso
R62 - Kotsi e ka bang teng ya thari e senyehileng
R63 - Kotsi e ka bang teng ya kotsi ho ngwana ya esong ho hlahe
Tlhaloso ea Tšireletseho S25 - Qoba ho kopana le mahlo.
S26 - Ha u kopana le mahlo, hlatsoa hang-hang ka metsi a mangata 'me u batle keletso ea bongaka.
S36/37 - Apara liaparo tsa tšireletso tse loketseng le liatlana.
S53 - Qoba ho pepeseha - fumana litaelo tse khethehileng pele u li sebelisa.
WGK Jeremane 3
RTECS HA3840000
HS Code 2942000000

122111-03-9 -Kopo:

Gemcitabine Hydrochloride (CAS: 122111-03-9) ke setlhare sa maiketsetso sa difluoro nucleoside se khahlanong le metabolism le anti-antineoplastic.E batlisisitsoe le ho ntlafatsoa ke Eli Lilly and Company 'me ea lumelloa ho ngolisoa Afrika Boroa, Sweden, Netherlands, Australia le linaheng tse ling ka 1995. United States Food and Drug Administration (FDA) e e amohetse e le phekolo ea pele. bakeng sa kalafo ea bongaka ea mofetše oa matšoafo oa sele e seng nyane le mofets'e oa pancreatic.
Lilemong tsa morao tjena, lithethefatsi tse ncha tse kang Gemcitabine, Paclitaxel, Docetaxel, Vinorebine ke lithethefatsi tse sebetsang bakeng sa phekolo ea kankere e seng e nyenyane ea kankere ea matšoafo (e khutsufalitsoeng NSCLC).Ha ho bapisoa le meriana ea setso ea chemotherapy, lithethefatsi tsena li na le melemo ea phello e phahameng ea phekolo le chefo e tlaase.Gemcitabine Hydrochloride ke moloko o mocha oa lithethefatsi tse khahlanong le metabolites le mofuta oa meriana e khethehileng bakeng sa potoloho ea lisele, e bapala karolo e kholo karolong ea DNA synthesis, e leng S phase ea lisele.Tlas'a maemo a itseng, moriana ona o ka thibela tsoelo-pele ea lisele ho tloha mokhahlelong oa G1 ho ea ho S, 'me oa ba le ts'ebetso e matla e khahlanong le mofets'e e seng mofets'e o monyane oa mofetše oa matšoafo oa sele (NSCLC).Lithuto tsa kantle ho naha li bonts'itse hore katleho ea kalafo e le 'ngoe bakeng sa NSCLC e nang le Gemcitabine Hydrochloride feela e ka ba 18% ~ 35%, ha e kopantsoe kalafo le cisplatin katleho ea NSCLC ke 41.7%.Ho NSCLC e tsoetseng pele, sekhahla se sebetsang sa carboplatin ke 16%, e ts'oanang le cisplatin, empa e na le chefo e tlase, haholo-holo bakeng sa karabelo ea mala, khatello ea moko oa masapo le karabelo e chefo ea liphio le methapo ea kutlo.Ha li kopantsoe le carboplatin, bobeli ba tsona li na le tšebelisano 'moho le phello ea tlatsetso,' me li ka hlahisa litlamorao tse phahameng tsa kalafo.

122111-03-9 -USP35 Standard:

Gemcitabine Hydrochloride
C9H11F2N3O4·HCl 299.66
Cytidine, 2′-deoxy-2′,2′-difluro-, monohydrochloride.
2'-Deoxy-2′, 2′-difluorocytidine monohydrochloride (β-isomer) [122111-03-9].
» Gemcitabine Hydrochloride e na le liperesente tse seng ka tlase ho 97.5 mme eseng ho feta liperesente tse 101.5 tsa C9H11F2N3O4·HCl, e baloang ho latela kamoo e leng kateng.
[Temoso-Gemcitabine Hydrochloride ke moemeli ea matla oa cytotoxic.Tlhokomelo e kholo e lokela ho nkoa ho thibela ho hema likaroloana le ho pepesa letlalo ho eona.]
Ho paka le ho boloka-Ho boloka ka lijaneng tse thata.
Labeling-Moo e reretsoeng ho sebelisoa ha ho etsoa liforomo tsa litekanyetso tse entoang, leibole e bolela hore ha e na nyopa kapa e tlameha ho sebetsoa hape nakong ea ho lokisoa ha liforomo tsa litekanyetso tse entoang.
USP Reference standards <11>-
USP Cytosine RS
USP Endotoxin RS
USP Gemcitabine Hydrochloride RS
Boitsebiso-
A: Infrared Absorption <197K>.
B: E finyella litlhoko tsa liteko tsa Chloride <191>.
Potoloho e khethehileng <781S>: pakeng tsa +43 le +50, ho 20.
Tharollo ea teko: 10 mg ka mL.
pH <791>: pakeng tsa 2.0 le 3.0, ka tharollo e nang le 10 mg ka mL.
Masala a ho khantša <281>: eseng ho feta 0.1%.
Litšepe tse boima, Mokhoa oa I <231>: 0.001%.
Bohloeki ba Chromatographic-
Tharollo A- Tsoela pele joalo ka ha ho laetsoe mohato oa Mobile ho Assay.
Tharollo B-Lokisetsa methanol e tlhotliloeng le e senyehileng.
Mobile phase-Sebelisa metsoako e feto-fetohang ea Tharollo A le Tharollo B joalokaha e laetsoe tlas'a tsamaiso ea Chromatographic.Etsa litokiso, ha ho hlokahala (sheba Tšebeliso ea Sistimi tlas'a Chromatography 621).
Tharollo ea ho tšoaneleha ha Sisteme-Tsoela pele joalo ka ha ho laetsoe ho Assay.
Tharollo e tloahelehileng-Hlakola palo e lekantsoeng hantle ea USP Gemcitabine Hydrochloride RS le USP Cytosine RS metsing, 'me u hlapolle ka bongata, le ha ho hlokahala, ho fumana tharollo e nang le khokahanyo e tsebahalang ea hoo e ka bang 2 µg ka mL ka 'ngoe.
Tharollo ea teko-Fetisetsa hoo e ka bang 50 mg ea Gemcitabine Hydrochloride, e lekantsoeng ka nepo, ho botlolo ea volumetric ea 25-mL, qhibiliha le ho hlapolla ka metsi ho ea holimo, 'me u kopanye.
Sistimi ea Chromatographic (bona Chromatography 621) -Tsoela pele joalo ka ha o laetsoe tlasa Assay.Chromatograph e hlophisitsoe ka tsela e latelang.
Nako (metsotso) Tharollo A (%) Tharollo B (%) Elution
0–8 97 3 ea boikemelo
8–13 97®50 3®50 lekhalo la mola
13–20 50 50 isocratic
20–25 50®97 50®3 tekatekano hape
Chromatograph ea tharollo ea ho tšoaneleha ha Sisteme, 'me u tlalehe likarabo tsa tlhōrō joalokaha li laetsoe bakeng sa Tsamaiso: linako tse lekanyelitsoeng tsa ho boloka li ka bang 0.5 bakeng sa gemcitabine -anomer le 1.0 bakeng sa gemcitabine;qeto, R, pakeng tsa gemcitabine -anomer le gemcitabine ha e ka tlase ho 8.0;'me ntlha ea mohatla bakeng sa gemcitabine ha e fete 1,5.Chromatograph the Standard solution, 'me u tlalehe likarabo tsa tlhōrō joalokaha li laetsoe bakeng sa Tsamaiso: linako tse lekanyelitsoeng tsa ho boloka li ka ba 0.1 bakeng sa cytosine le 1.0 bakeng sa gemcitabine;kheloha e lekanyelitsoeng bakeng sa liente tse ikatisang ha e fete 2.0%.
Ts'ebetso-Ka karohano kenya molumo (hoo e ka bang 20 µL) ea Tharollo e Tloaelehileng le tharollo ea Teko ka har'a chromatograph, rekota chromatogram, 'me u lekanye likarabelo tsohle tse phahameng.Bala peresente ea cytosine karolong ea Gemcitabine e nkiloeng ka foromo:
2.5(Cc / W)(rt / rs)
moo Cc e leng mahloriso a USP Cytosine RS ka har'a tharollo e tloaelehileng, ka µg ka mL;W ke boima, ka mg, ea Gemcitabine e nkiloeng;rt ke karabelo e phahameng ea cytosine ka tharollo ea Teko;'me rs ke karabelo ea cytosine ka tharollo e tloaelehileng: ha ho 0.1% ea cytosine e fumanoang.Bala liperesente tsa litšila tse ling ntle le cytosine karolong ea Gemcitabine e nkiloeng ka foromo:
2.5(Cs / W)(ri / rs)
moo Cs e leng khatello ea USP Gemcitabine Hydrochloride RS ka tharollo e tloaelehileng, ka µg ka mL;W ke boima, ka mg, ea Gemcitabine e nkiloeng;ri ke tlhōrō ea karabelo bakeng sa ho se hloeke ka 'ngoe ho Tharollo ea Tlhahlobo;'me rs ke karabelo ka lebaka la gemcitabine ka tharollo ea Maemo: ha e fete 0.1% ea gemcitabine -anomer kapa litšila tse ling tsa motho ka mong li fumanoa;mme kakaretso ya ditshila tsohle ha e fete 0.2%.Ha ke kenyeletse kakaretso ea litšila tsohle litlhoro life kapa life tse ka tlase ho moeli oa palo (0.02%).
Litlhoko tse ling-Moo leibole e bolelang hore Gemcitabine Hydrochloride ha e na likokoana-hloko, e kopana le litlhoko tsa Bakteria endotoxins le Sterility tlas'a Gemcitabine bakeng sa Ente.Moo lengolo le bolelang hore Gemcitabine Hydrochloride e tlameha ho etsoa ts'ebetsong e tsoelang pele nakong ea ho lokisoa ha liforomo tsa litekanyetso tse nang le ente, e kopana le litlhoko tsa Bakteria endotoxins tlas'a Gemcitabine bakeng sa Ente.
Tlhahlobo-
Mobile phase-Lokisetsa tharollo e tlhotliloeng le e senyehileng e nang le 13.8 g ea monobasic sodium phosphate le 2.5 mL ea phosphoric acid ka 1000 ml ea metsi.[hlokomela-The pH ea tharollo ena e pakeng tsa 2.4 le 2.6.]
Sistimi e loketseng tharollo-Fetisetsa ka 10 mg ea Gemcitabine Hydrochloride ho vial e nyane, eketsa 4 mL ea tharollo e nang le 168 mg ea potassium hydroxide ka mL ea methanol, cap ka thata, le sonicate.Chesa ho 55 bakeng sa lihora tse 6 ho isa ho tse 16, lumella ho pholile, 'me u fetise likahare ho 100-mL volumetric flask ka ho hlatsoa ka ho latellana ha 1% (v / v) phosphoric acid.Hlakola ka 1% ea asiti ea phosphoric ho bophahamo, 'me u kopanye.[hlokomela-Tharollo ena e na le hoo e ka bang 0.02 mg ka mL ea gemcitabine α-anomer.]
Tlhophiso e tloaelehileng-Hlakola tekanyo e lekantsoeng ka nepo ea USP Gemcitabine Hydrochloride RS ka metsing, 'me u hlapolle ka bongata, le ha ho hlokahala, ka metsi ho fumana tharollo e nang le motsoako o tsejoang oa hoo e ka bang 0.1 mg ka mL.
Ho lokisetsa tlhahlobo-Fetisetsa hoo e ka bang 20 mg ea Gemcitabine Hydrochloride, e lekantsoeng ka nepo, ho botlolo ea volumetric ea 200-mL, qhibiliha le ho hlapolla ka metsi ho ea holimo, le ho kopanya.
Chromatographic system (sheba Chromatography <621>) -Mokelikeli oa chromatograph o na le mochine oa 275-nm le kholomo ea 4.6-mm × 25-cm e nang le 5-µm packing L7.Sekhahla sa phallo ke hoo e ka bang 1.2 mL ka motsotso.Chromatograph ea tharollo ea ho tšoaneleha ha Sisteme, 'me u tlalehe likarabo tsa tlhōrō joalokaha li laetsoe bakeng sa Tsamaiso: qeto, R, pakeng tsa gemcitabine -anomer le gemcitabine ha e ka tlaase ho 8.0;'me ntlha ea mohatla e ikemiselitseng ho tloha gemcitabine ha e fete 1,5.Chromatograph ea Boitokisetso ba Maemo, 'me u tlalehe likarabelo tse phahameng joalo ka ha li laetsoe bakeng sa Ts'ebetso: kheloha e lekanyelitsoeng bakeng sa liente tse ikatisang ha e fete 1.0%.
Ts'ebetso-Ka karohano kenya meqolo e lekanang (hoo e ka bang 20 µL) ea ho hlophisoa ha Standard le ho hlophisoa ha Assay ho chromatograph, rekota li-chromatogram, 'me u lekanye likarabo tsa litlhoro tse kholo.Bala palo, ka mg, ea C9H11F2N3O4·HCl karolong ea Gemcitabine Hydrochloride e nkiloeng ka foromo:
200C(rU / rS)
moo C e leng mahloriso, ka mg ka mL, ea USP Gemcitabine Hydrochloride RS ho lokisetsa Standard;'me rU le rS ke likarabelo tse phahameng tse fumanoeng ho tsoa ho Tokisetso ea Assay le Tokiso ea Maemo, ka ho latellana.