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Ikhwalithi Enhle Ikhwalithi Ephakeme I-Pancreatin CAS 8049-47-6 enenani Elingcono Kakhulu


  • Inombolo ye-CAS:8049-47-6
  • IKHODI YE-HS:3507.9090.90
  • Isevisi Yefayela:I-Chinese-GMP/EU-GMP/DMF/EU-DMF
  • I-Pharmacopoeia ejwayelekile:EP/USP/CP
  • Imininingwane Yomkhiqizo

    Omaka bomkhiqizo

    Inhlangano yethu igcizelela kakhulu ukuphatha, ukwethulwa kwabasebenzi abanekhono, kanye nokwakhiwa kweqembu, ukuzama kanzima ukuthuthukisa ikhwalithi nokuqaphela izikweletu zamalungu eqembu.Inhlangano yethu ithole ngempumelelo Isitifiketi se-IS9001 kanye Nesitifiketi Se-European CE Sekhwalithi Enhle Yekhwalithi Ephezulu Pancreatin CAS 8049-47-6 Ngenani Elingcono Kakhulu, Ukubona kuyakholelwa!Siwamukela ngobuqotho amathuba amasha aphesheya okusungula ukusebenzisana kwenkampani futhi silindele ukuhlanganisa ukusebenzelana nawo wonke amakhasimende asenesikhathi eside asungulwa.
    Inhlangano yethu igcizelela kakhulu ukuphatha, ukwethulwa kwabasebenzi abanekhono, kanye nokwakhiwa kweqembu, ukuzama kanzima ukuthuthukisa ikhwalithi nokuqaphela izikweletu zamalungu eqembu.Inhlangano yethu ithole ngempumelelo Isitifiketi se-IS9001 kanye Nesitifiketi se-European CE seI-China CAS 8049-47-6 kanye Nekhwalithi Ephezulu, Izixazululo zethu zikhiqizwa ngezinto ezinhle kakhulu zokusetshenziswa.Njalo nje, sihlala sithuthukisa uhlelo lokukhiqiza.Ukuze siqinisekise ikhwalithi engcono nesevisi, manje besigxile enqubweni yokukhiqiza.Sithole ukunconywa okuphezulu nguzakwethu.Sibheke ngabomvu ukusungula ubudlelwano bebhizinisi nawe.

    Imininingwane

    1. Izinhlamvu: I-Pancreatin iyimpushana ensundu kancane, e-amorphous noma insundu kancane ukuya kugranule enombala kakhilimu.Yakhiwa i-amylase, i-lipase ne-protease.

    2. Ukukhipha Umthombo: Amanyikwe engulube.

    3. inqubo: I-Pancreatin ikhishwa kuma-pancreas enempilo ngobuchwepheshe bethu obukhethekile bokukhipha.

    4 .Izinkomba kanye nokusetshenziswa: I-Pancreatin iyingxube yama-enzyme amaningana okugaya akhiqizwa amanyikwe engulube.Ingasetshenziswa embonini yezemithi, ukucutshungulwa kokudla, ukushuka, ukuwasha neminye imikhakha, enezinhlelo eziningi ezahlukene.

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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

    EP

    USP

    Izinhlamvu

    Impushana

    Impushana ensundu kancane, e-amorphous

    Impushana ensundu kancane, e-amorphous

    Impushana ensundu kancane, e-amorphous

    I-Granule

    Igranule enombala onsundu kancane ukuya kokhilimu

    Igranule enombala onsundu kancane ukuya kokhilimu

    Igranule enombala onsundu kancane ukuya kokhilimu

    Ukuhlonza

    ————

    Kuyavumelana

    ————

    Izivivinyo

    Okuqukethwe kwamafutha

    ≤20mg/g

    ≤ 5.0%

    ≤3.0%(<3USP);≤ 6.0%(≥3USP)

    Ukulahlekelwa ekomisweni

    ≤5.0% 105℃, 4h

    ≤ 5.0% 670Pa 60℃, 4h

    ≤ 5.0%Yomisa ku-Vacuum 60℃, 4h

    I-solvent eyinsalela

    ————

    ≤ 0.5%Ngokuya nge-EP(5.4)

    ≤ 0.5%Ngokuya nge-USP(467)

    Usayizi wezinhlayiya

    ————

    Ngokusho kwe-EP(2.1.4&2.9.12)

    Ngokusho kwe-USP(811)

    Isivivinyo

    I-Protease

    ≥600U/g

    1.0–5.2Ph.Eur.U/mg

    100-450USP.U/mg

    I-Amylase

    ≥7000U/g

    12.0-80.0Ph.Eur.U/mg

    100-500USP.U/mg

    Lipase

    ≥4000U/g

    15.0–130Ph.Eur.U/mg

    10–90USP.U/mg

    Ukungcola Kwe-Microbial

    I-TAMC

    ≤ 10000cfu/g

    ≤ 10000cfu/g

    ≤ 10000cfu/g

    I-TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Kuyavumelana

    Kuyavumelana

    Kuyavumelana

    I-Salmonella

    Kuyavumelana

    Kuyavumelana

    Kuyavumelana

    Inhlangano yethu igcizelela kakhulu ukuphatha, ukwethulwa kwabasebenzi abanekhono, kanye nokwakhiwa kweqembu, ukuzama kanzima ukuthuthukisa ikhwalithi nokuqaphela izikweletu zamalungu eqembu.Inhlangano yethu ithole ngempumelelo Isitifiketi se-IS9001 kanye Nesitifiketi Se-European CE Sekhwalithi Enhle Yekhwalithi Ephezulu Pancreatin CAS 8049-47-6 Ngenani Elingcono Kakhulu, Ukubona kuyakholelwa!Siwamukela ngobuqotho amathuba amasha aphesheya okusungula ukusebenzisana kwenkampani futhi silindele ukuhlanganisa ukusebenzelana nawo wonke amakhasimende asenesikhathi eside asungulwa.
    Ikhwalithi EnhleI-China CAS 8049-47-6 kanye Nekhwalithi Ephezulu, Izixazululo zethu zikhiqizwa ngezinto ezinhle kakhulu zokusetshenziswa.Njalo nje, sihlala sithuthukisa uhlelo lokukhiqiza.Ukuze siqinisekise ikhwalithi engcono nesevisi, manje besigxile enqubweni yokukhiqiza.Sithole ukunconywa okuphezulu nguzakwethu.Sibheke ngabomvu ukusungula ubudlelwano bebhizinisi nawe.


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