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Umgangatho ophakamileyo waseTshayina we-Pharmaceutical CAS 679809-58-6 Enoxaparin Sodium Antiviral Enoxaparin Sodium Enoxaparin


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

    Iithegi zeMveliso

    Siyazingca ngolonwabo olukhulu lomthengi kunye nokwamkelwa okubanzi ngenxa yokuqhubeka sisukela phezulu koluhlu ngalunye kwisisombululo kunye nokulungiswa koMgangatho oPhezulu waseTshayina Pharmaceutical CAS 679809-58-6Enoxaparin sodiumI-Antiviral Enoxaparin Sodium Enoxaparin, Singomnye wabavelisi abakhulu be-100% eTshayina.Iinkampani ezinkulu ezininzi zokurhweba zingenisa iimpahla ezivela kuthi, ke siya kukubonelela ngeyona thegi yexabiso isebenzayo kunye nawo wonke umgangatho ofanayo ukuba unomdla kuthi.
    Siyazingca ngolonwabo olukhulu lomthengi kunye nokwamkelwa okubanzi ngenxa yokuqhubeka sisukela phezulu kuluhlu ngalunye kwisisombululo kunye nokulungiswaEnoxaparin yaseTshayina, Enoxaparin sodium, Ulawulo olungqongqo lwekhwalithi lwenziwa kwikhonkco nganye yenkqubo yonke yemveliso.Sithemba ngokunyanisekileyo ukuseka intsebenziswano enobuhlobo kunye neyokuncedana kunye nawe.Ngokusekwe kurhwebo olukumgangatho ophezulu kunye nenkonzo egqibeleleyo yokuthengisa / emva kokuthengisa ngumbono wethu, abanye abathengi baye basebenzisane nathi ngaphezulu kweminyaka emi-5.

    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

    Siyazingca ngolonwabo olukhulu lomthengi kunye nokwamkelwa okubanzi ngenxa yokuphikelela kwethu kokusukela phezulu koluhlu ngalunye kwisisombululo kunye nokulungiswa koMgangatho oPhezulu waseTshayina Pharmaceutical CAS 679809-58-6 Enoxaparin Sodium Antiviral Enoxaparin Sodium Enoxaparin, Singomnye wabathengi. inkulu 100% abavelisi China.Iinkampani ezinkulu ezininzi zokurhweba zingenisa iimpahla ezivela kuthi, ke siya kukubonelela ngeyona thegi yexabiso isebenzayo kunye nawo wonke umgangatho ofanayo ukuba unomdla kuthi.
    Umgangatho ophezuluEnoxaparin yaseTshayina, I-Enoxaparin Sodium, ulawulo olungqongqo lwekhwalithi lwenziwa kwikhonkco nganye yenkqubo yonke yemveliso.Sithemba ngokunyanisekileyo ukuseka intsebenziswano enobuhlobo kunye nentsebenziswano kunye nawe.Ngokusekwe kurhwebo olukumgangatho ophezulu kunye nenkonzo egqibeleleyo yokuthengisa / emva kokuthengisa ngumbono wethu, abanye abathengi baye basebenzisane nathi ngaphezulu kweminyaka emi-5.


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