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Iimveliso

Umzi-mveliso we-OEM woKutya kwiBanga leMpahla ekrwada iPancreatin yokugaya kunye neSatifikethi se-GMP


  • Inombolo yeCAS:8049-47-6
  • IKHOWUDI ye-HS:3507.9090.90
  • Inkonzo Yefayile:IsiTshayina-GMP/EU-GMP/DMF/EU-DMF
  • Pharmacopoeia umgangatho:EP/USP/CP
  • Iinkcukacha zeMveliso

    Iithegi zeMveliso

    Umgangatho ophezulu uza 1st;uncedo luphambili;ishishini loshishino yintsebenziswano” yintanda-bulumko yethu yoshishino ehlala ijongwa kwaye ilandelwa lishishini lethu le-OEM Factory ye-Food Grade Raw Material Pancreatin yeDigestion kunye neSatifikethi se-GMP, Sidlala indima ephambili ekuboneleleni abathengi ngempahla elungileyo ekumgangatho ophezulu kwaye inobundlongondlongo. amatyala.
    Umgangatho ophezulu uza 1st;uncedo luphambili;ishishini loshishino yintsebenziswano” yintanda-bulumko yethu yoshishino ehlala ijongwa kwaye ilandelwa lishishini lethu ukuzeI-China Pancreatic Enzyme Umgubo wePancreatin kunye nomgubo wokugaya wePancreatic Enzyme Powder, Iimveliso zethu zithunyelwa kwihlabathi liphela.Abathengi bethu bahlala benelisekile ngomgangatho wethu othembekileyo, iinkonzo ezijoliswe kubathengi kunye namaxabiso akhuphisanayo.Injongo yethu “kukuqhubeka sifumana ukuthembeka kwakho ngokunikela iinzame zethu ekuphuculeni rhoqo iimveliso kunye neenkonzo zethu ukuze siqinisekise ulwaneliseko lwabasebenzisi bethu bokugqibela, abathengi, abasebenzi, ababoneleli kunye noluntu lwehlabathi esisebenzisana kulo”.

    Iinkcukacha

    1. Abalinganiswa: I-Pancreatin ngumgubo kancinane omdaka, o-amorphous okanye umdaka kancinci ukuya kwigranule enombala okhrimu.Iqulethwe yi-amylase, i-lipase kunye ne-protease.

    2. Ukukhutshwa Umthombo: Ipancreas yehagu.

    3. Inkqubo: I-Pancreatin itsalwa kwi-pancreas enempilo ye-porcine ngeteknoloji yethu yokukhupha iteknoloji ekhethekileyo.

    4 .Izibonakaliso kunye nokusetyenziswa: I-Pancreatin ngumxube wee-enzyme ezininzi zokugaya eziveliswa yi-pancreas ye-porcine.Ingasetyenziswa kwishishini lamachiza, ukusetyenzwa kokutya, ukuthambisa, ukuhlamba kunye nezinye iindawo, ezinoluhlu olubanzi lwezicelo.

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    Kutheni sisi?

    ·Iveliswe kwiworkshop yeGMP

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

    ·Imathiriyeli ekrwada iyalandeleka

    ·Thobela umgangatho 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

    CP

    EP

    USP

    Abalinganiswa

    Umgubo

    Umgubo kancinane omdaka, oneamorphous

    Umgubo kancinane omdaka, oneamorphous

    Umgubo kancinane omdaka, oneamorphous

    Igranule

    Igranule emdaka kancinci ukuya kumbala wekhrim

    Igranule emdaka kancinci ukuya kumbala wekhrim

    Igranule emdaka kancinci ukuya kumbala wekhrim

    Ukuchongwa

    ————

    Iyahambelana

    ————

    Iimvavanyo

    Umxholo wamafutha

    ≤20mg/g

    ≤ 5.0%

    ≤3.0%(<3USP);≤ 6.0%(≥3USP)

    Ilahleko ekomisweni

    ≤5.0% 105℃, 4h

    ≤ 5.0% 670Pa 60℃, 4h

    ≤ 5.0% Yomile kwiVacuum 60℃, 4h

    Isinyibilikisi esishiyekileyo

    ————

    ≤ 0.5% Ngokungqinelana ne-EP(5.4)

    ≤ 0.5%Ngokungqinelana ne-USP(467)

    Ubungakanani besuntswana

    ————

    Ngokwe-EP(2.1.4&2.9.12)

    Ngokutsho kweUSP(811)

    Isivavanyi

    Iprotease

    ≥600U/g

    1.0~5.2Ph.Eur.U/mg

    100-450USP.U/mg

    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 kweMicrobial

    TAMC

    ≤ 10000cfu/g

    ≤ 10000cfu/g

    ≤ 10000cfu/g

    I-TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Iyahambelana

    Iyahambelana

    Iyahambelana

    Salmonella

    Iyahambelana

    Iyahambelana

    Iyahambelana

    Umgangatho ophezulu uza 1st;uncedo luphambili;ishishini loshishino yintsebenziswano” yintanda-bulumko yethu yoshishino ehlala ijongwa kwaye ilandelwa lishishini lethu le-OEM Factory ye-Food Grade Raw Material Pancreatin yeDigestion kunye neSatifikethi se-GMP, Sidlala indima ephambili ekuboneleleni abathengi ngempahla elungileyo ekumgangatho ophezulu kwaye inobundlongondlongo. amatyala.
    OEM Factory forI-China Pancreatic Enzyme Umgubo wePancreatin kunye nomgubo wokugaya wePancreatic Enzyme Powder, Iimveliso zethu zithunyelwa kwihlabathi liphela.Abathengi bethu bahlala benelisekile ngomgangatho wethu othembekileyo, iinkonzo ezijoliswe kubathengi kunye namaxabiso akhuphisanayo.Injongo yethu “kukuqhubeka sifumana ukuthembeka kwakho ngokunikela iinzame zethu ekuphuculeni rhoqo iimveliso kunye neenkonzo zethu ukuze siqinisekise ulwaneliseko lwabasebenzisi bethu bokugqibela, abathengi, abasebenzi, ababoneleli kunye noluntu lwehlabathi esisebenzisana kulo”.


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