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Iimveliso eziTsha ezishushu iPancreatin (iNombolo ye-CAS 8049-47-6) iFactory ye-GMP eqinisekisiweyo


  • 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

    Sihlala sifumana umsebenzi ukuba sibe ngabasebenzi ababambekayo ukuqinisekisa ukuba sinokukunika ngokulula umgangatho ophezulu kunye nelona xabiso likhulu kwiiMveliso eziTsha eziTshayo zePancreatin (iNombolo ye-CAS 8049-47-6) i-GMP Factory Cetificied, Kuphela ukufezekisa. imveliso esemgangathweni okanye inkonzo yokwanelisa imfuno yomthengi, zonke iimveliso zethu ziye zahlolwa ngokungqongqo phambi kokuba zithunyelwe.
    Sihlala sifumana umsebenzi wenziwe ukuba sibe ngabasebenzi ababambekayo ukuqinisekisa ukuba sinokukunika ngokulula owona mgangatho uphakamileyo kunye nexabiso elikhuluChina Pancreatin kunye 8049-47-6, Ngokuqhubeka nokusungula izinto ezintsha, siya kukunika izinto ezibaluleke ngakumbi kunye neenkonzo, kwaye senze igalelo kuphuhliso loshishino lweemoto ekhaya nakwamanye amazwe.Bobabini abarhwebi basekhaya nabangaphandle bamkelekile ngamandla ukuba bahlanganyele nathi ukuze sikhule kunye.

    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

    Sihlala sifumana umsebenzi ukuba sibe ngabasebenzi ababambekayo ukuqinisekisa ukuba sinokukunika ngokulula umgangatho ophezulu kunye nelona xabiso likhulu kwiiMveliso eziTsha eziTshayo zePancreatin (iNombolo ye-CAS 8049-47-6) i-GMP Factory Cetificied, Kuphela ukufezekisa. imveliso esemgangathweni okanye inkonzo yokwanelisa imfuno yomthengi, zonke iimveliso zethu ziye zahlolwa ngokungqongqo phambi kokuba zithunyelwe.
    Iimveliso eziNtsha ezishushuChina Pancreatin kunye 8049-47-6, Ngokuqhubeka nokusungula izinto ezintsha, siya kukunika izinto ezibaluleke ngakumbi kunye neenkonzo, kwaye senze igalelo kuphuhliso loshishino lweemoto ekhaya nakwamanye amazwe.Bobabini abarhwebi basekhaya nabangaphandle bamkelekile ngamandla ukuba bahlanganyele nathi ukuze sikhule kunye.


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