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Imikhiqizo

I-Pancreatin ye-Deebio ene-Powder, Granule kanye ne-Pellet


  • Inombolo ye-CAS:8049-47-6
  • IKHODI YE-HS:3507.9090.90
  • Imininingwane Yomkhiqizo

    Omaka bomkhiqizo

    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?

    Ikhiqizwe ku-workshop ye-GMP

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

    ·Izinto ezingavuthiwe ziyalandeleka

    ·Thobela izinga lamakhasimende

    Thekelisa 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

    I-granule enombala onsundu kancane ukuya kokhilimu

    I-granule enombala onsundu kancane ukuya kokhilimu

    I-granule 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

    1.05.2Ph.Eur.U/mg

    100450USP.U/mg

    I-Amylase

    ≥7000U/g

    12.080.0Ph.Eur.U/mg

    100500USP.U/mg

    Lipase

    ≥4000U/g

    15.0130Ph.Eur.U/mg

    1090USP.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


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