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Unikezelo olukhawulezayo China Chemicals Heparin Sodium


  • INOMBOLO YECAS.9041-08-1
  • IKHOWUDI ye-HS:3001.9010.00
  • Inkonzo Yefayile:IsiTshayina-GMP, iDMF
  • Pharmacopoeia umgangatho:EP/USP
  • Iinkcukacha zeMveliso

    Iithegi zeMveliso

    Ifemu yethu ibigxile kwisicwangciso sophawu.Ukwaneliseka kwabathengi yeyona ntengiso yethu ilungileyo.Sikwabonelela ngomboneleli we-OEM yonikezelo olukhawulezayo lweeChemical zaseChinaIsodium yeHeparin, Uphuculo olungapheliyo kunye nokuzabalazela ukunqongophala kwe-0% yimigaqo-nkqubo yethu yomgangatho ophambili emibini.Ukuba ufuna nantoni na, ungaze uthandabuze ukunxibelelana nathi.
    Ifemu yethu ibigxile kwisicwangciso sophawu.Ukwaneliseka kwabathengi yeyona ntengiso yethu ilungileyo.Sikwabonelela ngomboneleli we-OEMIsodium yeHeparin, Sikholelwa kumgangatho kunye nokwaneliseka kwabathengi okuphunyezwe liqela labantu abazinikele kakhulu.Iqela lenkampani yethu lisebenzisa itekhnoloji ye-cutting-edge lihambisa iimpahla ezikumgangatho ophezulu ezithandwa kakhulu kwaye zixatyiswa ngabathengi bethu kwihlabathi liphela.

    Iinkcukacha

    1. Abalinganiswa: Umgubo omhlophe okanye ophantse ube mhlophe, one-hygroscopic kakhulu.

    2. Umthombo: I-porcine intestine mucosa.

    3. Inkqubo: I-sodium ye-Heparin ikhutshwe kwi-porcine intestine mucosa enempilo.

    4. Izibonakaliso kunye nokusetyenziswa: Le mveliso isetyenziselwa ukuthintela isifo se-thromboembolic, ngokukodwa ifanelekileyo kwimfuno ye-anticoagulant ngokukhawuleza, njengale: 1. I-thrombosis ebukhali okanye engapheliyo ye-venous thrombosis okanye akukho tshintsho olubalulekileyo lokuhamba kwegazi oluguquguqukayo lwe-pulmonary embolism (PE) .Heparin inokumisa ukwandiswa kwe-embolus ukwenza ixesha lokuzivelela kwe-thrombolysis yomzimba.2. Ukuthintela kunye nokunyangwa kwe-Atrial fibrillation nge-embolism.3. Unyango lwe-early diffuse intravascular coagulation (DIC).4. Ukuthintela kunye nokunyangwa kwe-peripheral arterial thrombosis okanye i-myocardial infarction.5. Enye i-in vitro anticoagulation: efana notyando lwentliziyo, ukujikeleza kwe-vitro, i-hemodialysis, i-angiography, nayo ingasetyenziselwa utofelo-gazi okanye ukulungiswa kwe-specimen yegazi, okwangoku iimpawu eziphambili zokusetyenziswa kwe-heparin yi-deep vein thrombosis(DVT), i-PE kunye ne-thrombosis. kwizigulane ezisengozini enkulu.

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    Kutheni sisi?

    Upase iGMP yaseTshayina

    · Iminyaka engama-27 yembali ye-enzyme yebhayoloji ye-R&D

    ·Imathiriyeli ekrwada iyalandeleka

    ·Thobela USP,EP kunye nomgangatho wabathengi

    ·Thumela ngaphandle kumazwe angaphezu kwama-30 kunye nemimandla

    ·Unamandla olawulo lwenkqubo esemgangathweni efana ne-US FDA, Japan PMDA, South Korea MFDS, njl.

    Inkcazo

    Izinto zovavanyo

    Inkcazo yeNkampani

    EP

    USP

    Abalinganiswa

    Umgubo omhlophe okanye ophantse ube mhlophe, one-hygroscopic kakhulu

    Ukuchongwa

    I-Thrombotest: Iyahambelana

    Isazisi seChromatographic: Iyahambelana

    1I-H NMR Spectrum: Iyahambelana

    1I-H NMR Spectrum: Iyahambelana

    Ulwelo lweChromatography: Iyahambelana

    Ubunzima bobunzima bemolekyuli: 15000 ~ 19000

    ISodium: Iyahambelana

    ISodium: Iyahambelana

    I-Anti-factor Xa ukuya kwi-anti-factor IIa ratio: 0.9 ~ 1.1

    I-Anti-factor Xa ukuya kwi-anti-factor IIa ratio: 0.9 ~ 1.1

    Iimvavanyo

    Ukucaca kunye nombala

    Ukucaca: Cacileyo, Umbala: ngo-5 okanye ngaphezulu

    ————

    Nitrogen

    1.5-2.5% (into eyomileyo)

    1.3-2.5% (into eyomileyo)

    Ukungcola kwe-Nucleotidic

    A260≤ 0.15(4mg/ml)

    ≤ 0.1 (w/w)

    Izinto ezinxulumeneyo

    Iyahambelana

    ————

    Umda wegalactosamine kwihexosamine iyonke

    ————

    ≤ 1.0%

    I-Oversulfate chondroitin sulfate

    ————

    Iyahambelana

    pH

    5.5-8.0 (1%)

    5.5-7.5(1%)

    Ilahleko ekomisweni

    ≤ 8.0% (60℃ Yomile kwiVacuum, 3h)

    ≤ 5.0% (60℃ Yomile kwiVacuum, 3h)

    Intsalela ekutshisweni

    ————

    28.0%~41.0%

    I-endotoxin yebhaktheriya

    ≤ 0.01 IU / Iyunithi yamazwe ngamazwe yeHeparin

    ≤ 0.03 USP U / Iyunithi yamazwe ngamazwe yeHeparin

    Intsimbi enzima

    ≤ 30ppm

    ≤ 30ppm

    Isodium

    10.5-13.5% (into eyomileyo)

    ————

    Iiprotheyini

    ≤ 0.5% (into eyomileyo)

    ≤ 0.1% (Umlinganiselo wobunzima)

    Umsebenzi

    ≥ 180 IU/mg (into eyomileyo)

    ≥ 180 USP U/mg (into eyomileyo)

    Ukungcola kweMicrobial

    TAMC

    ≤ 1000cfu/g

    ≤ 1000cfu/g

    I-TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Iyahambelana

    Iyahambelana

    Staphylococcus aureus

    Iyahambelana

    Iyahambelana

    Salmonella

    Iyahambelana

    Iyahambelana

    Ifemu yethu ibigxile kwisicwangciso sophawu.Ukwaneliseka kwabathengi yeyona ntengiso yethu ilungileyo.Sikwabonelela ngomboneleli we-OEM yokuhanjiswa ngokukhawuleza kweChina iChemicals Heparin Sodium, ukuphuculwa okungapheliyo kunye nokuzabalazela ukusilela kwe-0% yimigaqo-nkqubo yethu yomgangatho ophambili emibini.Ukuba ufuna nantoni na, ungaze uthandabuze ukunxibelelana nathi.
    Ukuhanjiswa ngokukhawuleza kwe-China Anticoagulant, i-Pharmaceutical Intermediates, Sikholelwa kumgangatho kunye nokwaneliseka kwabathengi okuphunyezwe liqela labantu abazinikele kakhulu.Iqela lenkampani yethu lisebenzisa itekhnoloji ye-cutting-edge lihambisa iimpahla ezikumgangatho ophezulu ezithandwa kakhulu kwaye zixatyiswa ngabathengi bethu kwihlabathi liphela.


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