Gemcitabine Hydrochloride CAS 122111-03-9 API USP35 Ọkọlọtọ

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 nwere ọ bụghị ihe na-erughị pasent 97.5 na ọ bụghị karịa 101.5 pasent nke C9H11F2N3O4 · HCl, gbakọọ na ndabere.
[Akpachara anya-Gemcitabine Hydrochloride bụ ihe na-akpata cytotoxic nke nwere ike.Ekwesịrị ịkpachapụ anya nke ukwuu iji gbochie ikuru irighiri ihe na ikpughe akpụkpọ ahụ na ya.]
Nkwakọ ngwaahịa na nchekwa - Chekwaa n'ime akpa siri ike.
Labeling-Ebe e bu n'obi ka e jiri ya mee ihe n'ịkwadebe ụdị ọgwụgwọ injectable, akara ahụ na-ekwu na ọ dịghị mma ma ọ bụ na a ga-edozi ya n'ihu nhazi n'oge nkwadebe nke ụdị usoro onunu ogwu.
Ụkpụrụ ntụaka USP <11>-
USP Cytosine RS
USP Endotoxin RS
USP Gemcitabine Hydrochloride RS
njirimara-
A: Infrared absorption <197K>.
B: Ọ na-emezu ihe achọrọ maka ule maka Chloride <191>.
Ntụgharị a kapịrị ọnụ <781S>: n'etiti +43 na +50, na 20.
Ngwọta ule: 10 mg kwa ml.
pH <791>: n'etiti 2.0 na 3.0, na ngwọta nwere 10 mg kwa ml.
Ihe fọdụrụ na mgbanye <281>: ọ bụghị karịa 0.1%.
Ọla dị arọ, Usoro I <231>: 0.001%.
Chromatographic ịdị ọcha-
Ngwọta A- Gaba n'ihu dị ka akwadoro maka usoro mkpanaaka na Assay.
Ngwọta B- Kwadebe methanol akọrọ na degassed.
Usoro mkpanaaka-Jiri ngwakọta agbanwe agbanwe nke Ngwọta A na Ngwọta B dịka akwadoro n'okpuru sistemu Chromatographic.Mee mgbanwe, ọ bụrụ na ọ dị mkpa (lee Dabara Sistemu n'okpuru Chromatography 621).
Ngwọta ndabara sistemụ-Gaa n'ihu dị ka enyere ya na Assay.
Ọkọlọtọ ngwọta-Kwụsa USP Gemcitabine Hydrochloride RS na USP Cytosine RS n'ụzọ ziri ezi n'ime mmiri, na itughari quantitatively, na stepwise ma ọ bụrụ na ọ dị mkpa, iji nweta ngwọta na-enwe a maara mgbanye nke banyere 2 µg kwa ml nke ọ bụla.
Ngwọta nnwale - Nyefee ihe dị ka 50 mg nke Gemcitabine Hydrochloride, tụọ ya nke ọma, gaa na flask volumetric 25-mL, gbazee n'ime ma gbanye mmiri ka ọ bụrụ olu, ma gwakọta ya.
Sistemu chromatographic (lee Chromatography 621) -Gaa n'ihu dịka enyere ya n'okpuru nyocha.A na-ahazi chromatograph dị ka ndị a.
Oge (nkeji) Ngwọta A (%) Ngwọta B (%) Elution
0–8 97 3 isocratic
8–13 97®50 3®50 gradient linear
13–20 50 50 isocratic
20–25 50®97 50®3 nhazigharị
Chromatograph the System suitability solution, ma dekọọ nzaghachi kacha elu dị ka akwadoro maka Usoro: oge ​​njide ikwu ihe dị ka 0.5 maka gemcitabine -anomer na 1.0 maka gemcitabine;mkpebi ahụ, R, n'etiti gemcitabine -anomer na gemcitabine abụghị ihe na-erughị 8.0;na ihe ọdụdụ maka gemcitabine abụghị ihe karịrị 1.5.Chromatograph the Standard solution, wee dekọọ nzaghachi kacha elu dị ka akwadoro maka Usoro: oge ​​njide ikwu ihe dị ka 0.1 maka cytosine na 1.0 maka gemcitabine;Ọkọlọtọ ọkọlọtọ maka ntụtụ oyiri abụghị ihe karịrị 2.0%.
Usoro-gbanye otu olu (ihe dị ka 20 µL) nke ọkọlọtọ ọkọlọtọ na ngwọta nnwale n'ime chromatograph, dekọọ chromatogram, wee tụọ nzaghachi kacha elu.Gbakọọ pasent cytosine dị na mpaghara Gemcitabine nke usoro a were were:
2.5 (Cc / W) (rt / rs)
nke Cc bụ ntinye nke USP Cytosine RS na ngwọta ọkọlọtọ, na µg kwa ml;W bụ arọ, na mg, nke Gemcitabine weere;rt bụ nzaghachi kacha elu maka cytosine na ngwọta ule;na rs bụ nzaghachi maka cytosine na ngwọta Standard: ọ bụghị ihe karịrị 0.1% nke cytosine ka achọtara.Gbakọọ pasent nke adịghị ọcha ọ bụla na-abụghị cytosine na akụkụ Gemcitabine nke usoro a were were:
2.5 (Cs / W) (ri / rs)
nke Cs bụ ntinye nke USP Gemcitabine Hydrochloride RS na ngwọta ọkọlọtọ, na µg kwa ml;W bụ arọ, na mg, nke Gemcitabine weere;ri bụ nzaghachi kacha elu maka adịghị ọcha ọ bụla na ngwọta ule;na rs bụ nzaghachi n'ihi gemcitabine na Standard ngwọta: ọ bụghị karịa 0.1% nke gemcitabine-anomer ma ọ bụ onye ọ bụla ọzọ adịghị ọcha na-achọta;na nchikota nke adịghị ọcha niile abụghị ihe karịrị 0.2%.Wepụ na nchikota nke adịghị ọcha ọ bụla ọnụ ọgụgụ kasị elu n'okpuru oke nke nha (0.02%).
Ihe ndị ọzọ a chọrọ-Ebe akara ahụ na-ekwu na Gemcitabine Hydrochloride adịghị mma, ọ na-emezu ihe ndị a chọrọ maka nje bacteria endotoxins na Sterility n'okpuru Gemcitabine maka injection.Ebe akara na-ekwu na Gemcitabine Hydrochloride ga-edozi n'ihu nhazi n'oge nkwadebe nke injectable ụdị onunu ogwu, ọ na-emezu ihe a chọrọ maka nje endotoxins n'okpuru Gemcitabine maka injection.
Nyocha -
Usoro mkpanaaka - Kwadebe ihe nzacha na nke gbasasịa nke nwere 13.8 g nke monobasic sodium phosphate na 2.5 ml nke phosphoric acid na 1000 ml mmiri.[mara-PH nke ngwọta a dị n'etiti 2.4 na 2.6.]
Ngwọta dabara adaba sistemu - Nyefee ihe dị ka 10 mg nke Gemcitabine Hydrochloride na obere vial, tinye 4 ml nke ngwọta nwere 168 mg nke potassium hydroxide kwa ml nke methanol, okpu nke ọma, na sonicate.Kpoo ọkụ na 55 maka awa 6 ruo 16, kwe ka ọ dị jụụ, ma bufee ọdịnaya ahụ na 100-mL volumetric flask na nsonye 1% (v / v) phosphoric acid.Tinye 1% phosphoric acid ka ọ bụrụ olu, ma gwakọta ya.[mara-ihe ngwọta a nwere ihe dị ka 0.02 mg kwa ml nke gemcitabine α-anomer.]
Nkwadebe ọkọlọtọ-Gbasa oke USP Gemcitabine Hydrochloride RS nke a tụrụ n'ụzọ ziri ezi n'ime mmiri, wee gbagharịa n'ụzọ dị iche iche, na nzọụkwụ ọ bụla ma ọ bụrụ na ọ dị mkpa, na mmiri iji nweta ihe ngwọta na-enwe mkpokọta amara nke ihe dịka 0.1 mg kwa ml.
Nkwadebe nyocha- Nyefee ihe dị ka 20 mg nke Gemcitabine Hydrochloride, nke a tụrụ nke ọma, gaa na flask volumetric 200-mL, gbazee ma gbanye mmiri ka ọ bụrụ olu, ma gwakọta ya.
Usoro Chromatographic (lee Chromatography <621>) -Kromatograph mmiri mmiri nwere ihe nchọpụta 275-nm yana kọlụm 4.6-mm × 25-cm nke nwere 5-µm mbukota L7.Onu ogugu a bu ihe dika 1.2 ml kwa nkeji.Chromatograph the System suitability solution, ma dekọọ nzaghachi kacha elu dị ka eduzi maka Usoro: mkpebi, R, n'etiti gemcitabine -anomer na gemcitabine abụghị ihe na-erughị 8.0;na ihe ọdụdụ nke a na-ekpebi site na gemcitabine abụghị ihe karịrị 1.5.Chromatograph the Standard nkwadebe, na dekọọ nzaghachi kacha elu dị ka akwadoro maka Usoro: ihe ngbanwe ọkọlọtọ maka injections oyiri abụghị ihe karịrị 1.0%.
Usoro-iche iche nha nha (ihe dị ka 20 µL) nke nkwadebe ọkọlọtọ na nkwadebe Assay n'ime chromatograph, dekọọ chromatogram, wee tụọ nzaghachi maka ọnụ ọgụgụ ndị bụ isi.Gbakọọ ọnụọgụ, na mg, nke C9H11F2N3O4·HCl n'ime akụkụ Gemcitabine Hydrochloride nke usoro a were were:
200C (rU / rS)
nke C bụ ntinye uche, na mg kwa mL, nke USP Gemcitabine Hydrochloride RS na nkwadebe Standard;na rU na rS bụ nzaghachi kacha elu enwetara site na nkwadebe Assay na nkwado ọkọlọtọ, n'otu n'otu.