Gemcitabine Hydrochloride CAS 122111-03-9 API USP35 Heerka

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 wuxuu ka kooban yahay wax aan ka yarayn 97.5 boqolkiiba oo aan ka badnayn 101.5 boqolkiiba C9H11F2N3O4·HCl, oo loo xisaabiyay sida-ay tahay.
[Taxadir-Gemcitabine Hydrochloride waa wakiil cytotoxic ah oo awood leh.Waa in aad looga taxadaro si looga hortago in la neefsado oo maqaarka la soo bandhigo.]
Baakadaha iyo kaydinta-Ku xafid weel cidhiidhi ah.
Calaamadeynta-Halka loogu talagalay in loogu isticmaalo diyaarinta foomamka qiyaasta qiyaasta la isku duro, calaamaddu waxay sheegaysaa inay nadiif tahay ama ay tahay in la sii wado habayn dheeraad ah inta lagu jiro diyaarinta foomamka qiyaasta qiyaasta la isku duro.
Heerarka Tixraaca USP <11>-
USP Cytosine RS
USP Endotoxin RS
USP Gemcitabine Hydrochloride RS
Aqoonsiga -
J: Nuugista Infrared <197K>.
B: Waxay buuxisay shuruudaha shaybaarada Chloride <191>.
Wareeg gaar ah <781S>: inta u dhaxaysa +43 iyo +50, at 20.
Xalka tijaabada: 10 mg halkii ml.
pH <791>: inta u dhaxaysa 2.0 iyo 3.0, ee xal ka kooban 10 mg halkii ml.
Hadhaaga dabka <281>: aan ka badnayn 0.1%.
Biraha culus, Habka I <231>: 0.001%.
Daahirnimada Chromatographic-
Xalka A- U wad sida lagu faray wajiga mobaylka ee Assay.
Xalka B- Diyaari methanol la sifeeyay oo soo degsaday.
Marxaladda mobilada-Isticmaal isku dhafka kala duwan ee Xalka A iyo Xalka B sida lagu faray nidaamka Chromatographic hoostiisa.Samee hagaajin, haddii loo baahdo (eeg Habboonaanta Nidaamka ee hoos timaada Chromatography 621).
Xalka ku habboonaanta nidaamka-u wad sida lagu faray Assay.
Xalka caadiga ah-Ku milmaan tirada saxda ah ee USP Gemcitabine Hydrochloride RS iyo USP Cytosine RS biyaha, oo ku milo tiro ahaan, iyo si tartiib tartiib ah haddii loo baahdo, si loo helo xal la og yahay oo ku saabsan 2 µg halkii ml kasta.
Tijaabada xalka-Ku wareeji qiyaastii 50 mg ee Gemcitabine Hydrochloride, si sax ah loo miisaamay, ilaa 25-mL weel mug leh, ku milmi oo ku mil biyo ilaa mug, oo qas.
Nidaamka Chromatographic (eeg Chromatography 621) -U wad sida lagu faray Assay.chromatograph-ka waxa loo habeeyey sidan soo socota.
Waqtiga (daqiiqado) Xalka A (%) Xalka B (%) Elution
0-8 97 3 isocratic
8–13 97®50 3®50 jaanis toosan
13–20 50 50 isocratic
20–25 50®97 50®3 dib-u-habaynta
Chromatograph ee xalka ku habboonaanta Nidaamka, oo qor jawaabaha ugu sarreeya sida lagu faray Habraaca: waqtiyada haynta qaraabo waxay ku dhow yihiin 0.5 ee gemcitabine -anomer iyo 1.0 ee gemcitabine;xallinta, R, inta u dhaxaysa gemcitabine -anomer iyo gemcitabine waa mid aan ka yarayn 8.0;iyo qodobka dabada ee gemcitabine kama badna 1.5.Chromatograph the Standard Xalka, oo qor jawaabaha ugu sarreeya sida lagu faray Habraaca: waqtiyada haynta qaraabo waxay ku dhow yihiin 0.1 ee cytosine iyo 1.0 ee gemcitabine;jaangooyada heerka qaraabo ee cirbadaha soo noqnoqda kama badna 2.0%.
Habka-Si gooni ah u duri mugga (qiyaastii 20 µL) ee xalka caadiga ah iyo xalka tijaabada chromatograph-ka, duub chromatogram-ka, oo cabbir dhammaan jawaabaha ugu sarreeya.Xisaabi boqolkiiba cytosine ee qaybta Gemcitabine ee ay qaadatay qaacidada:
2.5 (Cc / W) (rt / rs)
kaas oo Cc uu yahay fiirsashada USP Cytosine RS ee xalalka caadiga ah, µg halkii ml;W waa miisaanka, mg, ee Gemcitabine la qaaday;rt waa jawaabta ugu sarreysa ee cytosine ee xalka tijaabada;iyo rs waa jawaabta cytosine ee xalka Heerka: in aan ka badnayn 0.1% ee cytosine ayaa la helay.Xisaabi boqolkiiba wasakh kasta oo aan ahayn cytosine ee qaybta Gemcitabine ee ay qaadatay qaacidada:
2.5 (Cs / W) (ri / rs)
taas oo Cs ay tahay fiirsashada USP Gemcitabine Hydrochloride RS ee xalka caadiga ah, µg halkii mL;W waa miisaanka, mg, ee Gemcitabine la qaaday;ri waa jawaabta ugu sarreysa ee wasakh kasta oo ku jirta xalka Imtixaanka;iyo rs waa jawaabta ay sabab u tahay gemcitabine ee xalalka Heerka: aan ka badnayn 0.1% gemcitabine -anomer ama wax kasta oo kale oo nijaas ah ayaa la helaa;iyo wadarta dhammaan wasakhda aan ka badnayn 0.2%.Ka saar wadarta dhammaan wasakhda wax kasta oo ugu sarreeya ee ka hooseeya xadka tirada (0.02%).
Shuruudaha kale-Halka ay calaamaddu ku sheegayso in Gemcitabine Hydrochloride uu nadiif yahay, waxay buuxinaysaa shuruudaha Bakteeriyada endotoxins iyo dhalmo la'aanta ee hoos timaada Gemcitabine ee duritaanka.Halka calaamaddu ay sheegayso in Gemcitabine Hydrochloride ay tahay in lagu sameeyo habayn dheeraad ah inta lagu jiro diyaarinta foomamka qiyaasta qiyaasta la isku duro, waxay buuxisaa shuruudaha bakteeriyada endotoxins ee hoos yimaada Gemcitabine ee duritaanka.
Imtixaan-
Marxaladda wareegta- Diyaari xal la sifeeyey oo soo degey oo ka kooban 13.8 g oo ah sodium phosphate monobasic iyo 2.5 mL oo fosfooraska acid ah 1000 ml oo biyo ah.[xusuusnow-pH ee xalkani wuxuu u dhexeeyaa 2.4 iyo 2.6.]
Xalka ku habboonaanta nidaamka-Ku wareeji qiyaastii 10 mg oo Gemcitabine Hydrochloride ah fijaal yar, ku dar 4 mL oo xal ah oo ka kooban 168 mg oo potassium hydroxide ah halkii mL ee methanol, dabool si adag, iyo sonicate.Kuleylka 55 ilaa 6 ilaa 16 saacadood, u ogolow inaad qaboojiso, oo ku wareeji waxa ku jira 100-mL weel mug leh oo leh dhaqid is daba joog ah oo ah 1% (v/v) phosphoric acid.Ku qas 1% phosphoric acid ilaa mugga, oo qas.[xusuusin-Xalkan wuxuu ka kooban yahay 0.02 mg halkii ml oo gemcitabine α-anomer ah.]
U diyaargarowga caadiga ah-Ku milmaan tirada saxda ah ee USP Gemcitabine Hydrochloride RS ee biyaha, oo ku milo tiro ahaan, iyo si tartiib tartiib ah haddii loo baahdo, biyo si aad u hesho xal iyada oo la og yahay fiirsashada 0.1 mg halkii ml.
Diyaarinta Assay-Ku wareeji qiyaastii 20 mg ee Gemcitabine Hydrochloride, si sax ah loo miisaamay, ilaa 200-mL weel mug leh, ku milmi oo ku milmaan biyo mugga, oo qas.
Nadaamka Chromatographic (eeg Chromatography <621>)-Kromaatograph-ka dareeraha ah waxa uu ku qalabaysan yahay 275-nm detector iyo 4.6-mm × 25-cm tiir oo ka kooban 5-µm xirmo L7.Heerka socodka waa qiyaastii 1.2 mL daqiiqadii.Chromatograph ee xalka ku habboonaanta Nidaamka, oo qor jawaabaha ugu sarreeya sida lagu faray Habka: xallinta, R, inta u dhaxaysa gemcitabine -anomer iyo gemcitabine kama yarayn 8.0;iyo qodobka dabada ee laga go'aamiyay gemcitabine kama badna 1.5.Chromatograph ee heerka diyaarinta, oo diwaangeli jawaabaha ugu sarreeya sida lagu faray Habraaca: jaangooyada heerka qaraabo ee cirbadaha soo noqnoqda kama badna 1.0%.
Habka-Si gooni ah u duri mugga siman (qiyaastii 20 µL) ee diyaarinta Heerka iyo diyaarinta Assay chromatograph-ka, duub chromatogram-yada, oo cabbir jawaabaha meelaha ugu sarreeya.Xisaabi tirada, mg, ee C9H11F2N3O4·HCl ee qaybta Gemcitabine Hydrochloride ee ay qaadatay qaacidada:
200C (rU / rS)
taas oo C ay tahay xoojinta, mg per mL, ee USP Gemcitabine Hydrochloride RS ee diyaarinta Standard;iyo rU iyo rS waa jawaabaha ugu sarreeya ee laga helay diyaarinta Assay iyo heerka diyaarinta, siday u kala horreeyaan.