Gemcitabine Hydrochloride CAS 122111-03-9 API 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 ili ndi zosachepera 97.5 peresenti komanso zosapitirira 101.5 peresenti ya C9H11F2N3O4 · HCl, yowerengedwa pa momwe ilili.
[Chenjezo-Gemcitabine Hydrochloride ndi cytotoxic wothandizira wamphamvu.Kusamala kwambiri kuyenera kuchitidwa kuti tipewe kutulutsa tinthu ting'onoting'ono ndikuyika khungu.]
Kupaka ndi kusunga-Sungani zotengera zothina.
Kulemba -Kumene amayenera kugwiritsidwa ntchito pokonzekera mafomu a jekeseni, chizindikirocho chimanena kuti ndi wosabala kapena ayenera kukonzedwanso panthawi yokonzekera mafomu a jekeseni.
Miyezo yolozera ya USP <11>-
USP Cytosine RS
USP Endotoxin RS
USP Gemcitabine Hydrochloride RS
Chizindikiritso-
A: Infrared mayamwidwe <197K>.
B: Imakwaniritsa zofunikira za mayeso a Chloride <191>.
Kusinthasintha kwachindunji <781S>: pakati pa +43 ndi +50, pa 20.
Njira yothetsera mayeso: 10 mg pa mL.
pH <791>: pakati pa 2.0 ndi 3.0, mu yankho lomwe lili ndi 10 mg pa mL.
Zotsalira pakuyatsa <281>: osapitirira 0.1%.
Zitsulo zolemera, Njira I <231>: 0.001%.
Chromatographic chiyero -
Yankho A- Pitirizani monga mwauzira gawo la Mobile mu Assay.
Yankho B-Konzani methanol osefedwa ndi degassed.
Mobile phase-Gwiritsani ntchito zosakanikirana zosakanikirana za Solution A ndi Solution B monga momwe zalembedwera pansi pa Chromatographic system.Sinthani, ngati kuli kofunikira (onani Kuyenerera Kwadongosolo pansi pa Chromatography 621).
Njira yothetsera kuyenerera kwadongosolo-Pitirizani monga momwe zalembedwera mu Assay.
Sungunulani muyezo woyezera bwino wa USP Gemcitabine Hydrochloride RS ndi USP Cytosine RS m'madzi, ndi kusungunula mochulukira, komanso pang'onopang'ono ngati kuli kofunikira, kuti mupeze yankho lodziwika bwino la pafupifupi 2 µg pa mL iliyonse.
Njira yothetsera mayeso-Chotsani pafupifupi 50 mg ya Gemcitabine Hydrochloride, yoyezedwa molondola, ku botolo la volumetric 25-mL, sungunulani ndi kusungunula ndi madzi mpaka voliyumu, ndi kusakaniza.
Chromatographic system (onani Chromatography 621) -Pitirizani monga mwawongolera pansi pa Assay.Chromatograph imapangidwa motere.
Nthawi (mphindi) Yankho A (%) Yankho B (%) Kuwunika
0–8 97 3 isokerasi
8–13 97®50 3®50 mzere wopendekera
13–20 50 50 isocratic
20–25 50®97 50®3 kugwirizanitsanso
Chromatograph njira yothetsera kuyenerera kwa System, ndikulemba mayankho apamwamba monga momwe adayankhidwira Ndondomeko: nthawi zosungirako zokhudzana ndi 0.5 za gemcitabine -anomer ndi 1.0 za gemcitabine;kusamvana, R, pakati pa gemcitabine -anomer ndi gemcitabine si osachepera 8.0;ndi tailing factor for gemcitabine is not more than 1.5.Chromatograph the Standard solution, ndipo lembani mayankho apamwamba monga momwe adayankhidwira Ndondomeko: nthawi zosungirako zokhudzana ndi 0.1 za cytosine ndi 1.0 za gemcitabine;Kupatuka kwapang'onopang'ono kwa jakisoni wobwereza sikudutsa 2.0%.
Kachitidwe-Mosiyana lowetsani voliyumu (pafupifupi 20 µL) ya njira Yokhazikika ndi njira Yoyesera mu chromatograph, lembani chromatogram, ndikuyesa mayankho onse apamwamba kwambiri.Werengani kuchuluka kwa cytosine mu gawo la Gemcitabine lotengedwa ndi formula:
2.5 (Cc / W) (rt / rs)
momwe Cc ndi kuchuluka kwa USP Cytosine RS mu Standard solution, mu µg pa mL;W ndi kulemera, mu mg, wa Gemcitabine wotengedwa;rt ndiye yankho lalikulu la cytosine mu yankho la Test;ndipo rs ndi yankho la cytosine mu Standard solution: osapitirira 0.1% ya cytosine amapezeka.Werengani kuchuluka kwa zonyansa zilizonse kupatula cytosine mu gawo la Gemcitabine lotengedwa ndi formula:
2.5 (Cs / W) (ri / rs)
momwe Cs ndi kuchuluka kwa USP Gemcitabine Hydrochloride RS mu Standard solution, mu µg pa mL;W ndi kulemera, mu mg, wa Gemcitabine wotengedwa;ri ndiye yankho lapamwamba pa zonyansa zilizonse mu yankho la Mayeso;ndipo rs ndi yankho chifukwa cha gemcitabine mu Standard solution: osapitirira 0.1% ya gemcitabine -anomer kapena zonyansa zina zilizonse zomwe zimapezeka;ndipo kuchuluka kwa zonyansa zonse sikudutsa 0.2%.Osapatula ku chiwopsezo cha zonyansa zonse nsonga zilizonse zomwe zili pansi pa malire a kuchuluka (0.02%).
Zofunikira zina-Kumene chizindikirocho chimanena kuti Gemcitabine Hydrochloride ndi wosabala, chimakwaniritsa zofunikira za mabakiteriya endotoxins ndi Kusabereka pansi pa Gemcitabine for Injection.Kumene chizindikirocho chimanena kuti Gemcitabine Hydrochloride iyenera kusinthidwanso panthawi yokonzekera mafomu a jekeseni, imakwaniritsa zofunikira za Bakiteriya endotoxins pansi pa Gemcitabine ya Injection.
Kuyesa-
Mobile phase-Konzani njira yosefedwa ndi degassed yomwe ili ndi 13.8 g ya monobasic sodium phosphate ndi 2.5 mL ya phosphoric acid mu 1000 mL yamadzi.[Dziwani-The pH ya yankho ili pakati pa 2.4 ndi 2.6.]
Dongosolo kuyenerera njira yothetsera-Choka za 10 mg wa Gemcitabine Hydrochloride kwa yaing'ono vial, kuwonjezera 4 mL ya njira munali 168 mg wa potaziyamu hydroxide pa mL wa methanol, kapu mwamphamvu, ndi sonicate.Kutenthetsa pa 55 kwa maola 6 mpaka 16, lolani kuziziritsa, ndikusamutsa zomwe zili mu botolo la volumetric 100-mL ndi kutsuka motsatizana kwa 1% (v / v) phosphoric acid.Sungunulani ndi 1% phosphoric acid mpaka voliyumu, ndikusakaniza.[Zindikirani-Yankho ili lili ndi pafupifupi 0.02 mg pa mL ya gemcitabine α-anomer.]
Kukonzekera kokhazikika-Sungani kuchulukana koyezera bwino kwa USP Gemcitabine Hydrochloride RS m'madzi, ndikuchepetsa mochulukira, komanso pang'onopang'ono ngati kuli kofunikira, ndi madzi kuti mupeze yankho lomwe lili ndi ndende yodziwika bwino ya 0.1 mg pa mL.
Kukonzekera koyesa-Kutumiza pafupifupi 20 mg ya Gemcitabine Hydrochloride, yoyezedwa molondola, ku botolo la volumetric 200-mL, sungunulani ndi kusungunula ndi madzi ku voliyumu, ndi kusakaniza.
Chromatographic system (onani Chromatography <621>) - Chromatograph yamadzimadzi imakhala ndi chowunikira cha 275-nm ndi ndime ya 4.6-mm × 25-cm yomwe ili ndi 5-µm packing L7.Kuthamanga kwa madzi ndi pafupifupi 1.2 ml pa mphindi.Chromatograph njira yothetsera kuyenerera kwa System, ndikulemba mayankho apamwamba monga momwe adalangizidwira Ndondomeko: chigamulo, R, pakati pa gemcitabine -anomer ndi gemcitabine sichichepera 8.0;ndipo chinthu chamchira chomwe chimatsimikiziridwa kuchokera ku gemcitabine sichiposa 1.5.Chromatograph the Standard kukonzekera, ndikujambulitsa mayankho apamwamba monga momwe adayankhidwira kachitidwe: kupotokola kofanana kwa jakisoni wobwereza sikudutsa 1.0%.
Dongosolo-Papatula jekeseni ma voliyumu ofanana (pafupifupi 20 µL) a Kukonzekera Kwanthawi zonse ndi kukonzekera kwa Assay mu chromatograph, lembani ma chromatogram, ndikuyesa mayankho a nsonga zazikulu.Werengetsani kuchuluka, mu mg, wa C9H11F2N3O4·HCl mu gawo la Gemcitabine Hydrochloride yotengedwa ndi formula:
200C(rU / rS)
momwe C ndi ndende, mu mg pa mL, wa USP Gemcitabine Hydrochloride RS mu kukonzekera Standard;ndi rU ndi rS ndiwo mayankho apamwamba omwe apezedwa kuchokera ku kukonzekera kwa Assay ndi kukonzekera kwa Standard, motsatana.