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Umzi-mveliso waMahla wesampulu yeMpahla ekrwada yeMpahla yePancreatin CAS 8049-47-6


  • 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

    Ukuphucula rhoqo inkqubo yolawulo ngomthetho othi "onyanisekileyo, ukholo oluhle kakhulu kunye nomgangatho ophezulu zisisiseko sophuhliso lweshishini", sithatha ngokubanzi isiseko seemveliso ezinxulumene namazwe ngamazwe, kwaye sihlala siphuhlisa iimveliso ezintsha ukuzalisekisa iminxeba yabathengi beFactory yaMahla yesampulu yeMpahla ekrwada yePancreatin CAS 8049-47-6, Okwangoku, sijonge phambili kwintsebenziswano enkulu ngakumbi nabathengi baphesheya ngokweenzuzo ezifanayo.Nceda ufumane amava simahla ukuze uqhagamshelane nathi ukuze ufumane iinkcukacha ezithe vetshe.
    Ukuphucula rhoqo inkqubo yolawulo ngomthetho othi "onyanisekileyo, ukholo oluhle kakhulu kunye nomgangatho ophezulu zisisiseko sophuhliso lweshishini", sithatha ngokubanzi isiseko seemveliso ezinxulumene namazwe ngamazwe, kwaye sihlala siphuhlisa iimveliso ezintsha ukuzalisekisa iminxeba yabathengi beChina Pancreatin kunye Pancreatin Powder, Umzi-mveliso wethu uxhotyiswe ngoncedo olupheleleyo kwi-10000 yeemitha zesikwere, esenza sikwazi ukwanelisa ukuvelisa kunye nokuthengisa uninzi lweemveliso zenxalenye yemoto kunye nezisombululo.Inzuzo yethu yinqanaba elipheleleyo, umgangatho ophezulu kunye nexabiso elikhuphisanayo!Ngokusekwe kuloo nto, iimpahla zethu zizuza ukunconywa okuphezulu kokubini ekhaya nakwamanye amazwe.

    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

    Ukuphucula rhoqo inkqubo yolawulo ngomthetho othi "onyanisekileyo, ukholo oluhle kakhulu kunye nomgangatho ophezulu zisisiseko sophuhliso lweshishini", sithatha ngokubanzi isiseko seemveliso ezinxulumene namazwe ngamazwe, kwaye sihlala siphuhlisa iimveliso ezintsha ukuzalisekisa iminxeba yabathengi beFactory yaMahla yesampulu yeMpahla ekrwada yePancreatin CAS 8049-47-6, Okwangoku, sijonge phambili kwintsebenziswano enkulu ngakumbi nabathengi baphesheya ngokweenzuzo ezifanayo.Nceda ufumane amava simahla ukuze uqhagamshelane nathi ukuze ufumane iinkcukacha ezithe vetshe.
    Factory Free isampuliChina Pancreatin kunye Pancreatin Powder, Umzi-mveliso wethu uxhotyiswe ngoncedo olupheleleyo kwi-10000 yeemitha zesikwere, esenza sikwazi ukwanelisa ukuvelisa kunye nokuthengisa uninzi lweemveliso zenxalenye yemoto kunye nezisombululo.Inzuzo yethu yinqanaba elipheleleyo, umgangatho ophezulu kunye nexabiso elikhuphisanayo!Ngokusekwe kuloo nto, iimpahla zethu zizuza ukunconywa okuphezulu kokubini ekhaya nakwamanye amazwe.


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