Gemcitabine Hydrochloride CAS 122111-03-9 API USP35 Standard

Tsanangudzo Pfupi

Zita reKemikari: Gemcitabine Hydrochloride

CAS: 122111-03-9

Chitarisiko: White Crystalline Powder, isina kunhuwa

Chiyero: 97.5% ~ 101.5% (Yakaverengerwa paDried Base)

API USP Standard, Commercial Production

Bata: Dr. Alvin Huang

Nharembozha/Wechat/WhatsApp: +86-15026746401

E-Mail: alvin@ruifuchem.com

Tumira email kwatiri

Product Detail

Product Tags

122111-03-9 - Tsanangudzo:

Ruifu Chemical ndiyo inotungamira mugadziri weGemcitabine Hydrochloride (CAS: 122111-03-9) ine mhando yepamusoro, kugadzirwa kwekutengesa.Ruifu Chemical inogona kupa kutumirwa kwepasirese, mutengo wemakwikwi, sevhisi yakanakisa, idiki uye yakawanda huwandu huripo.Tenga Gemcitabine Hydrochloride,Please contact: alvin@ruifuchem.com

122111-03-9 -Chemical Properties:

Chemical Name	Gemcitabine Hydrochloride
Mashoko anoreva zvakafanana	Gemcitabine HCl;2'-Deoxy-2',2'-Difluorocytidine Hydrochloride;dFdC;dFdCyd;Gemzar;LY188011 Hydrochloride;Gemcitera;Gemsar
Nhamba yeCAS	122111-03-9
Inoenderana CAS	95058-81-4 - Yemahara Base
Stock Status	MuStock, Kukwanisa Kugadzira 5 Matani
Molecular Formula	C9H12ClF2N3O4
Molecular Weight	299.66
Melting Point	>250 ℃
Shipping Condition	Under Ambient Temperature
COA & MSDS	Available
Origin	Shanghai, China
Brand	Ruifu Chemical

122111-03-9 -Zvinotsanangurwa:

Item	Zvinotsanangurwa	Results
Chitarisiko	Ichena Crystalline Powder, isina kunhuwa	Zvinoenderana
Solubility	Soluble muMvura, zvishoma soluble mu methanol, inenge isinganyunguriki muacetone	Zvinoenderana
Kuzivikanwa IR	IR spectrum inofanira kuenderana iyo yereference standard	Zvinoenderana
Kuzivikanwa Chloride	Positive.Iyo inosangana nezvinodiwa zvebvunzo dze chloride	Zvinoenderana
Kuonekwa kweSolution	Solution S yakajeka uye kwete zvakanyanya ine ruvara kupfuura referensi mhinduro BY7	Zvinoenderana
pH	2.0~3.0	2.6
Kutenderera kwakananga [α]20/D	+43.0 ° kusvika +50.0 °	+47.5°
Masimbi anorema (Pb)	≤10ppm	<10ppm
Kurasika paKuomesa	≤1.00%	0.3%
Residue paIgnition	≤0.10%	0.03%
Related Substances
Cytosine	≤0.10%	0.01%
α-Isomer	≤0.10%	0.01%
Chero Kumwe Kusachena	≤0.10%	0.04%
Zvose Zvisina Kuchena	≤0.20%	0.1%
Residual Solvents
Methanol	≤0.30%	Haina Kuonekwa
Toluene	≤0.01%	Haina Kuonekwa
Dichloromethane	≤0.01%	Haina Kuonekwa
Acetone	≤0.50%	0.1%
Assay	97.5% ~ 101.5% (Yakaverengerwa paDried Base)	99.9%
Mhedziso	Inoenderana neUSP35 Standard

Pakeji/Kuchengeta/Shipping:

Package:Bhodhoro, Aluminium foil bag, 25kg/Cardboard Drum, kana zvinoenderana nezvinodiwa nemutengi.
Storage Condition:Chengetedza mudziyo wakavharwa zvakasimba uye chengeta muimba inotonhorera, yakaoma uye ine mhepo yakanaka kure nezvinhu zvisingaenderani.Dzivisa kutarisana nezuva rakananga, unyoro uye kupisa kwakanyanya.
KutumiraKuendesa kupasirese nemhepo, neFedEx / DHL Express.Ipa kutumirwa nekukurumidza uye kwakavimbika.

Zvakanakira:

FAQ:

122111-03-9 - Njodzi uye Kuchengeteka:

Risk Codes R21 - Zvinokuvadza pakubata neganda
R36/38 - Kushungurudza maziso neganda.
R46 - Inogona kukonzera kukuvara kwemajini
R62 - Ngozi inogoneka yekukanganiswa kubereka
R63 - Ngozi inogoneka yekukuvadza kumwana asati azvarwa
Tsanangudzo Yekuchengetedza S25 - Dzivisa kusangana nemeso.
S26 - Kana wasangana nemaziso, simbura nekukasira nemvura yakawanda uye tsvaga mazano ekurapwa.
S36/37 - Pfeka zvipfeko zvekudzivirira zvakakodzera uye magurovhosi.
S53 - Dzivisa kuratidzwa - wana mirairo yakakosha usati washandisa.
WGK Germany 3
RTECS HA3840000
HS Code 2942000000

122111-03-9 -Application:

Gemcitabine Hydrochloride (CAS: 122111-03-9) ibhuku rekugadzira difluoro nucleoside mushonga unorwisa-metabolic uye antineoplastic.Yakatsvakurudzwa uye yakagadziridzwa neEli Lilly neKambani uye yakabvumirwa kuti inyore muSouth Africa, Sweden, Netherlands, Australia nedzimwe nyika muna 1995. United States Food and Drug Administration (FDA) yakabvumira kuti ive mushonga wekutanga. yekurapwa kwekiriniki isiri-diki cell cancer yemapapu uye pancreatic cancer.
Mumakore achangopfuura, mishonga mitsva yakadai seGemcitabine, Paclitaxel, Docetaxel, Vinorebine mishonga inoshanda yekurapa isiri-diki kenza yemapapu (yakapfupikiswa NSCLC).Kuenzaniswa nemishonga yechinyakare chemotherapy, mishonga iyi ine zvakanakira zvekurapa kwakanyanya uye kuderera muchetura.Gemcitabine Hydrochloride chizvarwa chitsva cheanorwisa-metabolites mushonga uye rudzi rwemushonga unokosha wesero kutenderera, uchitamba basa rakakura muDNA synthesis phase, inova S chikamu chemasero.Mune mamwe mamiriro ezvinhu, mushonga uyu unogona kudzivirira kufambira mberi kwemasero kubva kuG1 chikamu kuenda kuS chikamu, uye kuve neakasimba anti-kenza chiitiko chisiri chidiki cell cancer yemapapu (NSCLC).Zvidzidzo zvekunze zvakaratidza kuti kushanda kwekurapa kumwe chete kweNSCLC neGemcitabine Hydrochloride chete kunosvika 18% ~ 35%, uku kusanganisa kurapwa necisplatin kushanda kweNSCLC i41.7%.MuNSCLC yepamusoro, chiyero chinoshanda checarboplatin i16%, yakafanana necisplatin, asi ine muchetura wakaderera, kunyanya wekuita kwegastrointestinal, kudzvanywa kwemwongo uye kuita muchetura kweitsvo uye kuguma kwetsinga.Mukubatana ne carboplatin, ese ari maviri ane kuwirirana kurongeka uye yekuwedzera maitiro, uye anogona kuburitsa yakakwirira kurapa mhedzisiro.

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 ine isingasviki 97.5 muzana uye isingasviki 101.5 muzana yeC9H11F2N3O4 · HCl, yakaverengerwa pa-as-ihwo hwaro.
[Kuchenjerera-Gemcitabine Hydrochloride ine simba cytotoxic agent.Kungwarira kukuru kunofanirwa kutorwa kudzivirira kufemesa zvimedu uye kuburitsa ganda kwariri.]
Kurongedza uye kuchengetedza-Chengetedza mumidziyo yakaoma.
Labeling-Iko kwainoitirwa kushandiswa mukugadzira mafomu ekubaya jekiseni, iyo label inotaura kuti haina mbereko kana kuti inofanirwa kuenderera mberi nekugadziriswa panguva yekugadzirira mafomu ekubaya jekiseni.
USP Reference mwero <11>-
USP Cytosine RS
USP Endotoxin RS
USP Gemcitabine Hydrochloride RS
Identification-
A: Infrared Absorption <197K>.
B: Inosangana nezvinodiwa zvebvunzo dzeChloride <191>.
Kutenderera chaiko <781S>: pakati pe +43 ne +50, pa20.
Mhinduro yekuedza: 10 mg pa mL.
pH <791>: pakati pe2.0 ne3.0, mune mhinduro ine 10 mg per mL.
Residue pakudzima <281>: kwete kupfuura 0.1%.
Heavy metals, Nzira I <231>: 0.001%.
Chromatographic kuchena-
Solution A- Enderera sekurairwa kweMobile chikamu muAssay.
Solution B-Gadzirira yakasefa uye degassed methanol.
Nharembozha chikamu-Shandisa akasiyana musanganiswa weSolution A uye Solution B sekurairwa pasi peChromatographic system.Ita zvigadziriso, kana zvichidikanwa (ona System Suitability pasi peChromatography 621).
Kukodzera kweSistimu mhinduro-Enda sekurairwa muAssay.
Yakajairwa mhinduro-Dyisa huwandu hwakayerwa nemazvo eUSP Gemcitabine Hydrochloride RS uye USP Cytosine RS mumvura, uye dilute zvine huwandu, uye nhanho kana zvichidikanwa, kuwana mhinduro ine kuunganidzwa kunozivikanwa kunosvika 2 µg pa mL yega yega.
Test solution-Shandura inenge 50 mg yeGemcitabine Hydrochloride, yakanyatsoyerwa, kune 25-mL volumetric flask, nyunguduka mukati uye inyura nemvura kusvika kuhuwandu, uye sanganisa.
Chromatographic system (ona Chromatography 621) -Enda sekurairwa pasi peAssay.Iyo chromatograph yakarongedzwa sezvinotevera.
Nguva (maminetsi) Solution A (%) Solution B (%) Elution
0–8 97 3 isocratic
8–13 97®50 3®50 linear gradient
13–20 50 50 isocratic
20–25 50®97 50®3 kuenzana zvakare
Chromatograph the System suitability solution, uye rekodha mhinduro dzepamusoro sekutaurirwa kweProcedure: nguva dzekuchengetedza dzinenge dzinenge 0.5 ye gemcitabine -anomer uye 1.0 ye gemcitabine;chisarudzo, R, pakati pe gemcitabine -anomer uye gemcitabine haisi pasi pe8.0;uye iyo yemiswe ye gemcitabine haina kupfuura 1.5.Chromatograph the Standard solution, uye rekodha mhinduro dzepamusoro sekutaurirwa kweMaitiro: nguva dzekuchengetedza dzinenge 0.1 ye cytosine uye 1.0 ye gemcitabine;kutsauswa kwemaitiro ekudzokorodza majekiseni hakupfuuri 2.0%.
Maitiro-Baya jekiseni vhoriyamu (ingangoita 20 µL) yeStandard solution uye Test solution muchromatograph, rekodha chromatogram, uye kuyera ese epamusoro mhinduro.Verengai muzana ye cytosine muchikamu cheGemcitabine chakatorwa neformula:
2.5(Cc / W)(rt / rs)
umo Cc iri kuunganidzwa kweUSP Cytosine RS muStandard solution, muµg per mL;W ndiyo huremu, mumg, yeGemcitabine yakatorwa;rt ndiyo mhinduro yepamusoro ye cytosine muMubvunzo mhinduro;uye rs ndiyo mhinduro ye cytosine mu Standard solution: kwete kupfuura 0.1% ye cytosine inowanikwa.Verenga chikamu chekusachena kwega kwega kunze kwe cytosine muchikamu cheGemcitabine chakatorwa neformula:
2.5(Cs / W)(ri / rs)
umo maCs ari kusangana kweUSP Gemcitabine Hydrochloride RS muStandard solution, muµg per mL;W ndiyo huremu, mumg, yeGemcitabine yakatorwa;ri ndiyo mhinduro yepamusoro yekusachena kwega kwega muMubvunzo mhinduro;uye rs ndiyo mhinduro inokonzerwa negemcitabine muStandard solution: kwete kupfuura 0.1% ye gemcitabine -anomer kana chero imwe tsvina yemunhu inowanikwa;uye huwandu hwetsvina yese haipfuuri 0.2%.Usabvisa kubva muhuwandu hwese tsvina chero mapikisi ari pasi pemuganhu wehuwandu (0.02%).
Zvimwe zvinodiwa-Apo iyo label inotaura kuti Gemcitabine Hydrochloride haina mbereko, inosangana nezvinodiwa zveBacterial endotoxins uye Sterility pasi peGemcitabine yeJekiseni.Iko iyo label inotaura kuti Gemcitabine Hydrochloride inofanirwa kuenderera mberi nekugadziriswa panguva yekugadzirira mafomu ejekiseni, inosangana nezvinodiwa zveBacterial endotoxins pasi peGemcitabine yeJekiseni.
Kuongorora-
Nharembozha-Gadzirira mhinduro yakasefa uye yakasvibiswa ine 13.8 g ye monobasic sodium phosphate uye 2.5 mL ye phosphoric acid mu 1000 mL yemvura.[Cherechedza-Iyo pH yemhinduro iyi iri pakati pe2.4 ne2.6.]
System suitability solution-Shandura nezve 10 mg yeGemcitabine Hydrochloride kune bhodhoro duku, wedzera 4 mL yemhinduro ine 168 mg ye potassium hydroxide pa mL ye methanol, chivharo zvakasimba, uye sonicate.Kupisa pa55 kwemaawa matanhatu kusvika gumi nematanhatu, bvumira kutonhora, uye endesa zviri mukati mu 100-mL volumetric flask nekutevera kugezwa kwe1% (v/v) phosphoric acid.Dilute ne1% phosphoric acid kusvika kuhuwandu, uye sanganisa.[Cherechedza-Iyi mhinduro ine 0.02 mg pamL ye gemcitabine α-anomer.]
Kugadzirira kwakajairwa-Dyisa huremu hwakayerwa nemazvo hweUSP Gemcitabine Hydrochloride RS mumvura, uye dilute zvine mutsindo, uye nhanho kana zvichidikanwa, nemvura kuti uwane mhinduro ine uwandu hunozivikanwa hunosvika 0.1 mg per mL.
Kugadzirira kweAssay-Kutamisa nezve 20 mg yeGemcitabine Hydrochloride, yakanyatsoyerwa, kune 200-mL volumetric flask, nyunguduka mukati uye inyura nemvura kusvika kuhuwandu, uye sanganisa.
Chromatographic system (ona Chromatography <621>) -Iyo chromatograph yemvura inogadzirwa ne 275-nm detector uye 4.6-mm × 25-cm column ine 5-µm packing L7.Chiyero chekuyerera chinenge 1.2 mL paminiti.Chromatograph the System suitability solution, uye rekodha mhinduro dzepamusoro sekutaurirwa kweProcedure: sarudzo, R, pakati pe gemcitabine -anomer uye gemcitabine haisi pasi pe8.0;uye muswe chinhu chakatemwa kubva gemcitabine haisi kupfuura 1.5.Chromatograph iyo Yakajairwa gadziriro, uye rekodha mhinduro dzepamusoro sekurairwa kweMaitiro: chiyero chakajairwa kutsauswa kwemajekiseni anodzokorora hakusi kudarika 1.0%.
Procedure-Separate jekiseni mavhoriyamu akaenzana (angangoita 20 µL) eGwaro gadziriro uye gadziriro yeAssay muchromatograph, rekodha machromatogram, uye kuyera mhinduro dzepamusoro-soro.Verenga huwandu, mu mg, hweC9H11F2N3O4 · HCl muchikamu cheGemcitabine Hydrochloride yakatorwa neformula:
200C(rU / rS)
umo C ndiyo inosungirirwa, mu mg per mL, yeUSP Gemcitabine Hydrochloride RS muStandard gadziriro;uye rU nerS ndiwo mhinduro dzepamusoro dzakawanikwa kubva mukugadzirira kweAssay uye gadziriro yeStandard, zvichiteerana.