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urupapuro

Ibicuruzwa

Acide ya Ursodeoxycholic (UDCA) ya Deebio yo kuvura amabuye


  • URUBANZA OYA.:128-13-2
  • Kode ya HS:3504.0090.00
  • Ibicuruzwa birambuye

    Ibicuruzwa

    Ibisobanuro

    1. Inyuguti: Ifu yera;impumuro nziza.Iki gicuruzwa gishobora gushonga muri Ethanol, ariko ntigishobora gukomera muri chloroform;gushonga muri acide glacial acetic, no gushonga muri sodium hydroxide ikizamini.

    2. Inzira: Sintetike.

    3. Ibyerekana kandi bikoreshwa: Mu kuvura amabuye ya gallone, indwara yumwijima ya cholestique, umwijima wamavuta, ubwoko butandukanye bwa hepatite, indwara yumwijima wuburozi, cholecystitis, cholecystitis na dyspepsia ya biliary, gastritis bile, nibindi.

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    Kuki?

    · Yakozwe mu mahugurwa ya GMP

    · Imyaka 27 ya enzyme ya biologiya R&D amateka

    · Ibikoresho bibisi birashobora gukurikiranwa

    · Kubahiriza ibipimo byabakiriya nibigo

    · Kohereza mu bihugu n'uturere birenga 30

    · Ifite ubushobozi bwo gucunga neza sisitemu nka US FDA, Ubuyapani PMDA, Koreya yepfo MFDS, nibindi.

    Ibisobanuro

    Ibizamini

    Ukurikije ibipimo byimbere hamwe nibisanzwe byabakiriya

    KUBONA

    Ifu yera cyangwa hafi yera.

    GUSHYIRA MU RWEGO

    Hagati ya 200 ° C na 205 ° C.

    KUBONA UMWIHARIKO

    +57.0 〜 + 62.0 °

    GUTAKAZA KUMUKA

    ≤0.5%

    GUSIGA KUBITEKEREZO

    ≤0.1%

    ASSAY

    98.5% 〜101.5% (Ibintu byumye)

    KUBONA (HPLC)

    ≥98.5%

    KUBONA BIFITANYE ISANO (HPLC)

    .5 1.5% (Chenodeoxycholicacid)

    Ntibimenyekana

    ≤0.1% (Umwanda utazwi)

    0,05%

    ≤0.1% (Lithocholicacid)

    Ntibimenyekana

    .5 1.5% (Igiteranyo)

    0,10%

    KUBONA BIFITANYE ISANO (TLC)

    ≤O.05% (aside Lithocholike)

    Bikubiyemo

    .5 1.5% (Chenodeoxycholicacid)

    Bikubiyemo

    GUKURIKIRA

    Acetone : ≤5000ppm

    URUBUGA RWA MICROBIAL YUBUNTU

    < 103cfu / g

    UMWAKA UFATANYIJE UMWAKA / KUBARA MOLDS

    < 102cfu / g

    E.COLI

    Bikubiyemo

    SALMONELLAE

    Bikubiyemo

    UMWANZURO

    Yujuje ibyangombwa


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