Gemcitabine Hydrochloride CAS 122111-03-9 API maʻamau USP35

ʻO Gemcitabine Hydrochloride
C9H11F2N3O4·HCl 299.66
Cytidine, 2′-deoxy-2′,2′-difluro-, monohydrochloride.
2'-Deoxy-2',2'-difluorocytidine monohydrochloride (β-isomer) [122111-03-9].
» Aia ka Gemcitabine Hydrochloride ma lalo o 97.5 pākēneka a ʻaʻole ʻoi aku ma mua o 101.5 pākēneka o C9H11F2N3O4·HCl, i helu ʻia ma ke kumu like.
[E akahele-ʻO Gemcitabine Hydrochloride kahi mea hana cytotoxic ikaika.Pono e mālama nui ʻia i mea e pale ai i ka hoʻohu ʻana i nā ʻāpana a hōʻike i ka ʻili iā ia.]
Hoʻopili a mālama ʻia - mālama i loko o nā pahu paʻa.
Labeling-Ma kahi i manaʻo ʻia e hoʻohana i ka hoʻomākaukau ʻana i nā ʻano mea hoʻohana injectable, ʻōlelo ka lepili he sterile a pono e hoʻokau ʻia i ka hana hou ʻana i ka wā o ka hoʻomākaukau ʻana i nā ʻano ʻano injectable.
Nā kūlana hōʻike USP <11>-
USP Cytosine RS
USP Endotoxin RS
USP Gemcitabine Hydrochloride RS
ʻike-
A: Infrared Absorption <197K>.
B: Hoʻokō ia i nā koi o nā hoʻokolohua no Chloride <191>.
Ka hoʻololi kikoʻī <781S>: ma waena o +43 a me +50, ma 20.
Haʻina hoʻāʻo: 10 mg no ka mL.
pH <791>: ma waena o 2.0 a me 3.0, i loko o kahi hopena i loaʻa ka 10 mg no ka mL.
ʻO ke koena ma ka ʻā ʻana <281>: ʻaʻole ʻoi aku ma mua o 0.1%.
Nā metala kaumaha, Keʻano I <231>: 0.001%.
Chromatographic maemae-
Hoʻonā A- E hoʻomau e like me ke kuhikuhi ʻana no ka pae Mobile i ka Assay.
Pane B-E hoʻomākaukau i ka methanol i kānana ʻia.
ʻĀpana paʻalima-E hoʻohana i nā hui like ʻole o ka Solution A a me ka Solution B e like me ke kuhikuhi ʻana ma lalo o ka ʻōnaehana Chromatographic.Hana i nā hoʻololi, inā pono (e nānā i ka System Suitability ma lalo o Chromatography 621).
ʻO ka hoʻonā kūpono o ka ʻōnaehana-E hoʻomau e like me ke kuhikuhi ʻana i ka Assay.
ʻO ka hoʻonā maʻamau-E hoʻoheheʻe i ka nui o ka USP Gemcitabine Hydrochloride RS a me USP Cytosine RS i ka wai, a hoʻoheheʻe me ka nui, a me ka stepwise inā pono, e loaʻa i kahi hopena i ʻike ʻia ma kahi o 2 µg per mL o kēlā me kēia.
ʻO ka hopena ho'āʻo-E hoʻololi i kahi 50 mg o Gemcitabine Hydrochloride, i kaupaona pono ʻia, i kahi pahu volumetric 25-mL, hoʻoheheʻe i loko a hoʻoheheʻe ʻia me ka wai i ka nui, a hui.
Pūnaehana Chromatographic (e nānā i ka Chromatography 621)-E hoʻomau e like me ke kuhikuhi ʻana ma lalo o ka Assay.Hoʻolālā ʻia ka chromatograph penei.
Manawa (minuke) Hoʻonā A (%) Haʻina B (%) Elution
0–8 97 3 hoʻokalakupua
8–13 97®50 3®50 kaha kaha laina
13–20 50 50 hoʻokalakupua
20–25 50®97 50®3 hoʻoponopono hou
Chromatograph the System suitability solution, and record the peak responses as directed for Procedure: the relative retention times are about 0.5 for gemcitabine -anomer and 1.0 for gemcitabine;ʻo ka hoʻonā, R, ma waena o gemcitabine -anomer a me gemcitabine ʻaʻole i emi iho ma mua o 8.0;a ʻaʻole ʻoi aku ka nui o ka huelo no gemcitabine ma mua o 1.5.Chromatograph the Standard solution, a hoʻopaʻa i nā pane kiʻekiʻe e like me ke kuhikuhi ʻana no ke Kaʻina Hana: ʻo nā manawa paʻa pili ma kahi o 0.1 no cytosine a me 1.0 no gemcitabine;ʻaʻole ʻoi aku ka nui o ka ʻokoʻa maʻamau no ka hoʻopiʻi hou ʻana ma mua o 2.0%.
Kaʻina hana-Hoʻokaʻawale i ka leo (e pili ana i 20 µL) o ka mea hoʻonā maʻamau a me ka hopena hoʻāʻo i loko o ka chromatograph, hoʻopaʻa i ka chromatogram, a ana i nā pane kiʻekiʻe a pau.E helu i ka pākēneka o ka cytosine ma ka ʻāpana o Gemcitabine i lawe ʻia e ke kumu:
2.5(Cc / W)(rt / rs)
i loko o ka Cc ka manaʻo o ka USP Cytosine RS i ka hopena maʻamau, ma µg no mL;ʻO W ke kaumaha, ma ka mg, o Gemcitabine i lawe ʻia;ʻO rt ka pane kiʻekiʻe no ka cytosine i ka hoʻonā Ho'āʻo;a ʻo rs ka pane no ka cytosine i ka hoʻonā maʻamau: ʻaʻole i ʻoi aku ma mua o 0.1% o ka cytosine i loaʻa.E helu i ka pākēneka o kēlā me kēia haumia ʻē aʻe ma mua o ka cytosine ma ka ʻāpana o Gemcitabine i lawe ʻia e ke kumu:
2.5(Cs / W)(ri / rs)
i loko o ka Cs ka manaʻo o ka USP Gemcitabine Hydrochloride RS i loko o ka hopena maʻamau, ma µg no mL;ʻO W ke kaumaha, ma ka mg, o Gemcitabine i lawe ʻia;ʻO ri ka pane kiʻekiʻe no kēlā me kēia haumia i loko o ka hoʻonā Ho'āʻo;a ʻo rs ka pane ma muli o ka gemcitabine i loko o ka solution Standard: ʻaʻole i ʻoi aku ma mua o 0.1% o ka gemcitabine -anomer a i ʻole nā ​​​​mea haumia ʻē aʻe i loaʻa;a ʻaʻole ʻoi aku ka nui o nā haumia a pau ma mua o 0.2%.E hoʻokaʻawale mai ka huina o nā haumia a pau i nā piko ma lalo o ka palena o ka quantitation (0.02%).
Nā koi ʻē aʻe-Ma kahi e ʻōlelo ai ka lepili he sterile ʻo Gemcitabine Hydrochloride, hoʻokō ia i nā koi no nā endotoxins Bacterial a me Sterility ma lalo o Gemcitabine for Injection.Ma kahi e ʻōlelo ai ka lepili e pono e hoʻokau hou ʻia ʻo Gemcitabine Hydrochloride i ka wā o ka hoʻomākaukau ʻana i nā ʻano hana injectable, e hoʻokō i nā koi no nā endotoxins Bacterial ma lalo o Gemcitabine for Injection.
hoʻāʻo-
ʻĀpana paʻa-E hoʻomākaukau i kahi hopena kānana a hoʻopau ʻia me 13.8 g o ka sodium phosphate monobasic a me 2.5 mL o ka waikawa phosphoric i 1000 mL o ka wai.[note-ʻO ka pH o kēia hopena ma waena o 2.4 a me 2.6.]
ʻO ka hoʻonā kūpono o ka ʻōnaehana-E hoʻololi i ka 10 mg o Gemcitabine Hydrochloride i kahi hue liʻiliʻi, e hoʻohui i 4 mL o kahi hopena i loaʻa ka 168 mg o ka potassium hydroxide no ka mL o ka methanol, pāpale paʻa, a me ka sonicate.E wela ma 55 no 6 a 16 mau hola, e ʻae i ka maʻalili, a e hoʻololi i nā mea i loko o kahi pahu volumetric 100-mL me ka holoi ʻana o 1% (v/v) phosphoric acid.E hoʻoheheʻe me 1% phosphoric acid i ka nui, a hui.[note-ʻO kēia hoʻonā ma kahi o 0.02 mg no ka mL o gemcitabine α-anomer.]
Hoʻomākaukau maʻamau-E hoʻoheheʻe i ka nui o ka USP Gemcitabine Hydrochloride RS i ka wai, a dilute quantitatively, a me ka stepwise inā pono, me ka wai e loaʻa ai kahi hopena i ʻike ʻia ma kahi o 0.1 mg no ka mL.
Hoʻomākaukau hoʻāʻo-Hoʻololi e pili ana i 20 mg o Gemcitabine Hydrochloride, i kaupaona pono ʻia, i kahi pahu volumetric 200-mL, hoʻoheheʻe i loko a hoʻoheheʻe ʻia me ka wai i ka nui, a hui pū.
Pūnaehana Chromatographic (e nānā i ka Chromatography <621>)-Ua hoʻolako ʻia ka chromatograph wai me kahi mea ʻike 275-nm a me kahi kolamu 4.6-mm × 25-cm i loaʻa iā 5-µm packing L7.ʻO ka nui o ke kahe ʻana ma kahi o 1.2 mL i kēlā me kēia minuke.Chromatograph the System suitability solution, and record the peak responses as directed for Procedure: the resolution, R, between the gemcitabine -anomer and gemcitabine is not less than 8.0;a ʻo ke kumu huelo i hoʻoholo ʻia mai ka gemcitabine ʻaʻole i ʻoi aku ma mua o 1.5.Chromatograph i ka hoʻomākaukau maʻamau, a hoʻopaʻa i nā pane kiʻekiʻe e like me ke kuhikuhi ʻana no ke Kaʻina Hana: ʻaʻole ʻoi aku ka ʻokoʻa maʻamau pili no ka hoʻopili hou ʻana ma mua o 1.0%.
Kaʻina hana-Hoʻokaʻawale i nā puke like (ma kahi o 20 µL) o ka hoʻomākaukau maʻamau a me ka hoʻomākaukau ʻana i ka Assay i loko o ka chromatograph, e hoʻopaʻa i nā chromatograms, a ana i nā pane no nā piko nui.E helu i ka nui, i ka mg, o C9H11F2N3O4·HCl i loko o ka hapa o Gemcitabine Hydrochloride i lawe ʻia e ke kumu:
200C(rU / rS)
i loko o ka C ka manaʻo, i ka mg per mL, o USP Gemcitabine Hydrochloride RS i ka hoʻomākaukau maʻamau;a ʻo rU a me rS nā pane kiʻekiʻe i loaʻa mai ka hoʻomākaukau Assay a me ka hoʻomākaukau maʻamau.