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Ubushobozi Bwinshi Ubushinwa Heparin Sodium


  • URUBANZA OYA.:9041-08-1
  • Kode ya HS:3001.9010.00
  • Serivisi ya dosiye:Igishinwa-GMP 、 DMF
  • Ibipimo bya Pharmacopoeia:EP / USP
  • Ibicuruzwa birambuye

    Ibicuruzwa

    Turagerageza kuba indashyikirwa, duhuza abakiriya ”, twizera kuzaba itsinda ryiza ry’ubufatanye n’ubucuruzi bwiganje ku bakozi, abatanga isoko ndetse n’abakiriya, bamenya kugabana agaciro no gukomeza kwamamaza kuri High PerformanceUbushinwa Heparin Sodium, Ntabwo gusa dutanga ubuziranenge buhebuje kubakiriya bacu, ariko inyongera niyo ikomeye ni serivisi zacu zikomeye hiyongereyeho igiciro cyo kugurisha.
    Turagerageza kuba indashyikirwa, dushyira hamwe abakiriya ”, twizera kuzaba itsinda ryiza ry’ubufatanye n’ubucuruzi bwiganje ku bakozi, abatanga isoko n’abakiriya, bamenya kugabana agaciro no gukomeza kwamamaza kuriUbushinwa Heparin Sodium, Guhaza kwabakiriya nigihe cyose dushakisha, gushiraho agaciro kubakiriya burigihe ninshingano zacu, umubano muremure wigihe kirekire hagati yubucuruzi nicyo dukora.Twabaye umufatanyabikorwa wizewe rwose mubibazo byawe mubushinwa.Nibyo, izindi serivisi, nkubujyanama, zirashobora gutangwa.

    Ibisobanuro

    1. Inyuguti: Ifu yera cyangwa hafi yera, hygroscopique cyane.

    2. Inkomoko: mucosa amara.

    3. Inzira: Sodium ya Heparin ikurwa muri mucosa nziza yo mu mara.

    4. Ibyerekana kandi bikoreshwa: Iki gicuruzwa gikoreshwa cyane cyane mukurinda indwara ya tromboembolique, cyane cyane ikenewe mugukenera anticoagulant byihuse, nka: 1. 1. Trombose ikaze cyangwa idakira cyangwa nta maraso akomeye atembera neza ihinduka ryimpyiko (PE) .Heparin Irashobora kwaguka kwa embolus kugirango ikore umwanya wa trombolysis yumubiri.2. Kwirinda no kuvura fibrillation ya Atrial hamwe na embolism.3. Kuvura hakiri kare gukwirakwiza imitsi y'amaraso (DIC).4. Kwirinda no kuvura periferique arterial trombose cyangwa infirasiyo ya myocardial.5. Ibindi muri vitro anticoagulation: nko kubaga umutima-mitsi, kubagwa kwa vitro, hemodialysis, angiography, nabyo birashobora gukoreshwa muguterwa cyangwa gutegura amaraso, kuri ubu ibimenyetso byingenzi byerekana imiti ya heparin ni trombose ndende (DVT), PE na trombose mu barwayi bafite ibyago byinshi.

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    Kuki?

    · Yatsinze abashinwa GMP

    · Imyaka 27 ya enzyme ya biologiya R&D amateka

    · Ibikoresho bibisi birashobora gukurikiranwa

    · Kurikiza USP 、 EP hamwe nibisanzwe byabakiriya

    · Kohereza mu bihugu n'uturere birenga 30

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

    Ibisobanuro

    Ibizamini

    Ibisobanuro bya sosiyete

    EP

    USP

    Inyuguti

    Ifu yera cyangwa hafi yera, hygroscopique cyane

    Kumenyekanisha

    Thrombotest: Ihuza

    Indangamuntu ya Chromatografiya: Ihuza

    1H NMR Ikirangantego: Ihuza

    1H NMR Ikirangantego: Ihuza

    Amazi ya Chromatografiya: Ihuza

    Uburemere-buringaniye bwa molekuline: 15000 ~ 19000

    Sodium: Ihuza

    Sodium: Ihuza

    Kurwanya ibintu Xa kugereranya anti-factor IIa: 0.9 ~ 1.1

    Kurwanya ibintu Xa kugereranya anti-factor IIa: 0.9 ~ 1.1

    Ibizamini

    Kugaragara no kurangi

    Ibisobanuro: Birasobanutse, Ibara: kuri 5 cyangwa byiza

    ————

    Azote

    1.5 ~ 2,5% substance ibintu byumye)

    1.3 ~ 2,5% substance ibintu byumye)

    Nucleotidic umwanda

    A260≤ 0.15 (4mg / ml)

    ≤ 0.1 (w / w)

    Ibintu bifitanye isano

    Guhuza

    ————

    Imipaka yagalactosamine muri hexosamine yose

    ————

    ≤ 1.0%

    Kurenza urugero rwa chondroitine sulfate

    ————

    Guhuza

    pH

    5.5 ~ 8.0 (1%)

    5.5 ~ 7.5 (1%)

    Gutakaza kumisha

    ≤ 8.0% (60 ℃ Kuma muri Vacuum, 3h)

    ≤ 5.0% (60 ℃ Kuma muri Vacuum, 3h)

    Ibisigisigi byo gutwikwa

    ————

    28.0% ~ 41.0%

    Indwara ya bagiteri

    ≤ 0.01 IU / Igice mpuzamahanga cya Heparin

    ≤ 0.03 USP U / Ishami mpuzamahanga rya Heparin

    Icyuma kiremereye

    ≤ 30ppm

    ≤ 30ppm

    Sodium

    10.5 ~ 13.5% substance ibintu byumye)

    ————

    Poroteyine

    ≤ 0.5% substance ibintu byumye)

    ≤ 0.1% ratio Ikigereranyo cy'uburemere)

    Igikorwa

    ≥ 180 IU / mg substance ibintu byumye)

    ≥ 180 USP U / mg substance ibintu byumye)

    Microbial Impurities

    TAMC

    ≤ 1000cfu / g

    ≤ 1000cfu / g

    TYMC

    C 100cfu / g

    C 100cfu / g

    E.coli

    Guhuza

    Guhuza

    Staphylococcus aureus

    Guhuza

    Guhuza

    Salmonella

    Guhuza

    Guhuza

    Turagerageza kuba indashyikirwa, duhuza abakiriya ”, twizera kuzaba itsinda ryiza ry’ubufatanye n’ubucuruzi bwiganje ku bakozi, abatanga isoko ndetse n’abakiriya, bamenya kugabana agaciro no gukomeza kwamamaza kuri High PerformanceUbushinwa Heparin SodiumNtabwo gusa dutanga ubuziranenge bwo hejuru kubakiriya bacu, ariko byongeye kandi byingenzi ni serivisi zacu zikomeye hiyongereyeho igiciro cyo kugurisha.
    Ubushobozi Bwinshi Ubushinwa Heparin, Guhaza kwabakiriya nigihe cyose dushakisha, guha agaciro abakiriya burigihe ninshingano zacu, umubano muremure wigihe kirekire hagati yubucuruzi nicyo dukora.Twabaye umufatanyabikorwa wizewe rwose mubibazo byawe mubushinwa.Nibyo, izindi serivisi, nkubujyanama, zirashobora gutangwa.


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