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Izinkampani Zokukhiqiza zase-China Organic Intermediate Kallikrein CAS 9001-01-8 Ikhwalithi ephezulu


  • INOMBOLO YECAS.9001-01-8
  • IKHODI YE-HS:3507.9090.90
  • Isevisi Yefayela:I-Chinese-GMP, i-DMF
  • I-Pharmacopoeia ejwayelekile:I-JP/CP
  • Imininingwane Yomkhiqizo

    Omaka bomkhiqizo

    Mayelana nezintengo ezincintisanayo zokuthengisa, sikholwa ukuthi uzobe usesha kude nakude nanoma yini engasehlula.Sizosho ngokuqiniseka okuphelele ukuthi ngamanani anjalo amahle kakhulu kumanani anjalo siphansi kakhulu ezinkampanini Zokukhiqiza ze-China Organic Intermediate Kallikrein CAS 9001-01-8 Ikhwalithi Ephezulu, Siyakwamukela wonke amaklayenti ahlala nakwamanye amazwe ukuthi aye enkampanini yethu, ukuze enze ubumbano. isikhathi eside esihle ngokubambisana kwethu.
    Mayelana nezintengo ezincintisanayo zokuthengisa, sikholwa ukuthi uzobe usesha kude nakude nanoma yini engasehlula.Sizosho ngokuqiniseka okuphelele ukuthi ngamanani anjalo amahle kakhulu singabaphansi kakhulu kuwoI-China Chemical, Umuthi, Njengoba siyizixazululo eziphezulu zefekthri yethu, uchungechunge lwethu lwezixazululo luhloliwe futhi lwasizuza izitifiketi zeziphathimandla ezinolwazi.Ukuze uthole amapharamitha engeziwe nemininingwane yohlu lwezinto, qiniseka ukuthi uchofoza inkinobho ukuze uthole ulwazi olwengeziwe.

    Imininingwane

    1. Izinhlamvu: Impushana emhlophe noma ecishe ibe mhlophe, engenaphunga.

    2. Ukukhipha Umthombo: Amanyikwe engulube.

    3. Inqubo: I-Kallidinogenase ikhishwa kumanyikwe engulube enempilo.

    4. Izinkomba kanye nokusetshenziswa:Lo mkhiqizo ungasetshenziselwa izifo ezihlukahlukene zenhliziyo nemithambo yegazi, njengesifo senhliziyo, i-cerebral arteriosclerosis, i-cerebral thrombosis, ukuphazamiseka kokunikezwa kwegazi kwe-retinal kanye nesifo se-vascular peripheral.Ukuba nomthelela ongcono wokwelapha ocwaningweni lwakamuva lokuvikela i-microangiopathy yesifo sikashukela kanye ne-nephropathy yesifo sikashukela, kunganciphisa ukukhishwa kwe-albumin.Idatha yomtholampilo ekhaya naphesheya iphakamisa ukuthi ingakhuphula ukusebenza kwesidoda kanye nenani lokukhiqiza, futhi inomphumela othile wokwelapha ekwelapheni ubunyumba bowesilisa.

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    Kungani sisi?

    ·Kwenziwe ku-workshop ye-GMP

    ·Iminyaka engama-27 yomlando we-enzyme yebhayoloji ye-R&D

    ·Izinto ezingavuthiwe ziyalandeleka

    ·Thobela izinga lamakhasimende

    ·Thumela emazweni nasezifundeni ezingaphezu kuka-30

    ·Inekhono lokuphatha uhlelo lwekhwalithi njenge-US FDA, Japan PMDA, South Korea MFDS, njll.

    Ukucaciswa

    Izinto Zokuhlola

    Ukucaciswa Kwenkampani

    CP

    JP

    Izinhlamvu

    Impushana emhlophe noma ecishe ibe mhlophe, engenaphunga

    Impushana emhlophe kuya kokuncane, ayinaphunga noma iqulekile

    Ukuhlonza

    R (isilinganiso se-hydrolysis): 0.12–0.17

    R (isilinganiso se-hydrolysis): 0.12–0.16

    I-Liquid Chromatography: Iyavumelana

    Mina : ≤ 0.2

    Izivivinyo

    pH

    5.5-7.5 (300unit/ml)

    5.5–7.5(1g/300ml)

    Ukucaca kwesixazululo

    Sula (2mg/ml)

    ————

    Amafutha

    ≤ 5.0mg/g

    ≤ 1.0mg/g

    Kininase

    ————

    R Inani:≥ 0.8

    Into efana ne-trypsin

    ————

    T Inani:≤ 0.05

    I-Protease

    A280≤ 0.2

    A280≤ 0.2

    Ukulahlekelwa ekomisweni

    ≤ 5.0% (60℃ Yomisa ku-Vacuum, 4h)

    ≤ 2.0% (60℃ Yomisa ku-Vacuum, 4h)

    Izinsalela ekushiseni

    ≤ 3.0%

    ≤ 3.0%

    Umsebenzi wokukhipha i-Kinin

    ————

    ≥ 500ng bradykinin okulingana/umzuzu/iyunithi ngeyunithi ngayinye

    Ubumsulwa

    ≥ 75% (okomlomo)

    ————

    ≥ 90% (umjovo)

    I-endotoxin yebhaktheriya

    ≤ 2.5 EU/iyunithi (yomjovo)

    ————

    Isivivinyo

    Umsebenzi wama-enzyme

    ————

    ≥ 25 iyunithi/mg

    Umsebenzi othize

    ≥ 300 iyunithi/mg amaprotheni (omlomo)

    ≥ 100 iyunithi/mg amaprotheni

    ≥ 600 unit/mg protein (yomjovo)

    Ukungcola Kwe-Microbial

    I-TAMC

    ≤ 1000cfu/g (okomlomo)

    ≤ 1000cfu/g

    ≤ 100cfu/g (yomjovo)

    I-TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Kuyavumelana

    Kuyavumelana

    I-Salmonella

    Kuyavumelana

    Kuyavumelana

    Mayelana nezintengo ezincintisanayo zokuthengisa, sikholwa ukuthi uzobe usesha kude nakude nanoma yini engasehlula.Sizosho ngokuqiniseka okuphelele ukuthi ngamanani anjalo amahle kakhulu kumanani anjalo siphansi kakhulu ezinkampanini Zokukhiqiza ze-China Organic Intermediate Kallikrein CAS 9001-01-8 Ikhwalithi Ephezulu, Siyakwamukela wonke amaklayenti ahlala nakwamanye amazwe ukuthi aye enkampanini yethu, ukuze enze ubumbano. isikhathi eside esihle ngokubambisana kwethu.
    Izinkampani Zokukhiqiza zeI-China Chemical, Umuthi, Njengoba siyizixazululo eziphezulu zefekthri yethu, uchungechunge lwethu lwezixazululo luhloliwe futhi lwasizuza izitifiketi zeziphathimandla ezinolwazi.Ukuze uthole amapharamitha engeziwe nemininingwane yohlu lwezinto, qiniseka ukuthi uchofoza inkinobho ukuze uthole ulwazi olwengeziwe.


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