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 ya ƙunshi ba kasa da 97.5 bisa dari kuma bai wuce 101.5 bisa dari na C9H11F2N3O4·HCl, lissafta a kan as-shine tushe.
[Cution-Gemcitabine Hydrochloride wakili ne mai ƙarfi na cytotoxic.Yakamata a kula sosai don hana shakar barbashi da bayyanar da fata gareta.]
Marufi da ajiya-Ajiye a cikin matsuguni.
Lakabi-Inda aka yi nufin amfani da shi wajen shirya nau'ikan alluran allura, alamar ta bayyana cewa ba ta da lafiya ko kuma dole ne a ƙara sarrafa shi yayin shirye-shiryen fom ɗin allura.
Matsayin Magana na USP <11>-
USP Cytosin RS
USP Endotoxin RS
USP Gemcitabine Hydrochloride RS
Ganewa-
A: Ciwon Infrared <197K>.
B: Ya cika ka'idodin gwaje-gwaje don Chloride <191>.
Takamaiman juyawa <781S>: tsakanin +43 da +50, a 20.
Maganin gwaji: 10 MG kowace ml.
pH <791>: tsakanin 2.0 da 3.0, a cikin wani bayani dauke da 10 MG da ml.
Ragowa akan kunnawa <281>: bai wuce 0.1% ba.
Karfe masu nauyi, Hanyar I <231>: 0.001%.
Tsaftar Chromatographic-
Magani A- Ci gaba kamar yadda aka umarce shi don lokacin Wayar hannu a cikin Assay.
Magani B-Shirya tace da degassed methanol.
Lokacin wayar hannu-Yi amfani da gauraya masu canji na Magani A da Magani B kamar yadda aka umurce su a ƙarƙashin tsarin Chromatographic.Yi gyare-gyare, idan ya cancanta (duba Dacewar Tsarin ƙarƙashin Chromatography 621).
Maganin dacewa da tsarin-ci gaba kamar yadda aka umarce shi a cikin Assay.
Daidaitaccen bayani-Narke daidaitaccen adadin USP Gemcitabine Hydrochloride RS da USP Cytosine RS a cikin ruwa, kuma a tsarke ƙima, da mataki-mataki idan ya cancanta, don samun bayani yana da sananniya na kusan 2 µg kowace ml na kowane.
Magani na gwaji-Canja wurin kusan 50 MG na Gemcitabine Hydrochloride, daidai a auna, zuwa filaye mai girma na 25-mL, narke a ciki kuma a tsoma shi da ruwa zuwa girma, da haɗuwa.
Tsarin Chromatographic (duba Chromatography 621) - Ci gaba kamar yadda aka umarce shi a ƙarƙashin Assay.An tsara chromatograph kamar haka.
Lokaci (minti) Magani A (%) Magani B (%) Elution
0-8 97 3 masu son kai
8-13 97®50 3®50 layin layi
13-20 50 50 mai son kai
20-25 50®97 50®3 sake daidaitawa
Chromatograph da tsarin dacewa da tsarin, da kuma rikodin amsawar kololuwa kamar yadda aka tsara don Tsari: lokutan riƙewa na dangi kusan 0.5 don gemcitabine -anomer da 1.0 don gemcitabine;ƙuduri, R, tsakanin gemcitabine -anomer da gemcitabine ba kasa da 8.0;kuma ma'aunin wutsiya na gemcitabine bai wuce 1.5 ba.Chromatograph the Standard bayani, da kuma rikodin mafi girman martani kamar yadda aka ba da umarni don Tsari: lokutan riƙewar dangi kusan 0.1 don cytosine da 1.0 don gemcitabine;Matsakaicin ma'auni na dangi don maimaita injections bai wuce 2.0%.
Tsari-Na dabam allurar ƙara (kimanin 20 µL) na daidaitaccen bayani da gwajin gwaji a cikin chromatograph, yi rikodin chromatogram, da auna duk mafi girman martani.Yi lissafin adadin cytosine a cikin ɓangaren Gemcitabine da aka ɗauka ta dabara:
2.5 (Cc / W) (rt / rs)
a cikin abin da Cc shine ƙaddamar da USP Cytosine RS a cikin daidaitaccen bayani, a cikin µg kowace ml;W shine nauyin nauyi, a cikin mg, na Gemcitabine da aka ɗauka;rt shine mafi girman martani ga cytosine a cikin maganin gwajin;kuma rs shine mayar da martani ga cytosine a cikin Daidaitaccen bayani: ba a sami fiye da 0.1% na cytosine ba.Ƙididdige adadin kowane ƙazanta ban da cytosine a cikin ɓangaren Gemcitabine da aka ɗauka ta dabara:
2.5 (Cs / W) (ri / rs)
a cikin abin da Cs shine ƙaddamar da USP Gemcitabine Hydrochloride RS a cikin daidaitaccen bayani, a cikin µg kowace ml;W shine nauyin nauyi, a cikin mg, na Gemcitabine da aka ɗauka;ri shine mafi girman martani ga kowane rashin tsarki a cikin maganin gwajin;kuma rs shine amsawa saboda gemcitabine a cikin Ma'auni na Ma'auni: ba fiye da 0.1% na gemcitabine -anomer ko duk wani rashin tsarki na mutum yana samuwa;kuma jimillar duk najasa bai wuce 0.2% ba.Keɓe daga jimlar duk ƙazanta kowane kololuwa waɗanda ke ƙasa da iyakar ƙididdigewa (0.02%).
Sauran buƙatun-Inda alamar ta bayyana cewa Gemcitabine Hydrochloride ba ta da lafiya, ta cika buƙatun don ƙwayoyin cuta na endotoxins da Sterility a ƙarƙashin Gemcitabine don allura.Inda lakabin ya bayyana cewa Gemcitabine Hydrochloride dole ne a ƙaddamar da ƙarin aiki yayin shirye-shiryen nau'ikan nau'ikan alluran allura, ya dace da buƙatun ƙwayoyin endotoxins a ƙarƙashin Gemcitabine don allura.
Assay-
Wayar hannu lokaci-Shirya taceccen bayani mai tacewa wanda ke ɗauke da 13.8 g na monobasic sodium phosphate da 2.5 ml na phosphoric acid a cikin 1000 ml na ruwa.[bayanin kula-pH na wannan maganin yana tsakanin 2.4 da 2.6.]
Maganin dacewa da tsarin - Canja wurin kusan 10 MG na Gemcitabine Hydrochloride zuwa ƙaramin vial, ƙara 4 ml na maganin da ke ɗauke da 168 MG na potassium hydroxide a kowace ml na methanol, hula tam, da sonicate.Yi zafi a 55 na tsawon sa'o'i 6 zuwa 16, ba da izini don kwantar da hankali, da kuma canja wurin abin da ke ciki zuwa gilashin 100-mL mai girma tare da wankewa na 1% (v / v) phosphoric acid.Tsarma da 1% phosphoric acid zuwa girma, da kuma Mix.[bayanin kula-Wannan bayani ya ƙunshi kusan 0.02 MG kowace ml na gemcitabine α-anomer.]
Daidaitaccen shiri-Narke adadin USP Gemcitabine Hydrochloride RS daidai wanda aka auna a cikin ruwa, kuma a tsoma shi da yawa, kuma a mataki-mataki idan ya cancanta, da ruwa don samun bayani yana da sananniya na kusan 0.1 MG kowace ml.
Shirye-shiryen Assay-Canja wurin kusan 20 MG na Gemcitabine Hydrochloride, daidai a auna, zuwa filaye mai girma na 200-mL, narke a ciki kuma a tsoma shi da ruwa zuwa girma, da haɗuwa.
Tsarin Chromatographic (duba Chromatography <621>) -Chromatograph na ruwa yana sanye da na'urar ganowa 275-nm da ginshiƙin 4.6-mm × 25-cm wanda ya ƙunshi 5-µm tattara L7.Matsakaicin kwarara shine kusan 1.2 ml a minti daya.Chromatograph da tsarin dacewa da tsarin, da kuma rikodin amsawar kololuwa kamar yadda aka tsara don Tsarin: ƙuduri, R, tsakanin gemcitabine -anomer da gemcitabine ba kasa da 8.0;kuma abin da aka ƙaddara daga gemcitabine bai wuce 1.5 ba.Chromatograph da Daidaitaccen shiri, da rikodin mafi girman martani kamar yadda aka ba da umarni don Tsari: madaidaitan ma'auni don maimaita alluran bai wuce 1.0% ba.
Tsari-Na dabam allura daidai juzu'i (kimanin 20 µL) na daidaitaccen shiri da shirye-shiryen Assay a cikin chromatograph, yi rikodin chromatograms, da auna martani ga manyan kololuwa.Yi ƙididdige adadin, a cikin MG, na C9H11F2N3O4·HCl a cikin ɓangaren Gemcitabine Hydrochloride wanda aka ɗauka ta dabara:
200C (rU / rS)
wanda C shine maida hankali, a cikin MG da ml, na USP Gemcitabine Hydrochloride RS a cikin Shirye-shiryen Standard;da rU da rS sune mafi girman martanin da aka samu daga shirye-shiryen Assay da Daidaitaccen shiri, bi da bi.