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Ixabiso loKhuphiswano lweBanga lokuTya laseTshayina iPancreatin yokugaya kunye neSatifikethi se-ISO (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

    Sinesinye sezona zixhobo zivelisa izinto ezintsha, iinjineli ezinamava kunye nabaqeqeshiweyo kunye nabasebenzi, baqaphela iinkqubo zokuphatha ezisemgangathweni kunye neqela elinobuhlobo elinamava okufumana ingeniso phambi / emva kokuthengisa ngeXabiso loKhuphiswano lweChina iBanga lokuTya iPancreatin yeDigestion kunye neSatifikethi se-ISO ( I-CAS 8049-47-6), Ishishini lethu lakhula ngokukhawuleza ngobukhulu kunye nokuthandwa ngenxa yokuzinikela ngokupheleleyo kwimveliso ekumgangatho ophezulu, ixabiso elikhulu leemveliso kunye nomnikezeli wabathengi omangalisayo.
    Sinesinye sezona zixhobo zivelisa izinto ezintsha, iinjineli ezinamava kunye nabaqeqeshiweyo kunye nabasebenzi, baqaphela iinkqubo zokuphatha ezisemgangathweni kunye neqela elinobuhlobo elinamava okufumana inkxaso kwangaphambili / emva kokuthengisaChina Pancreatic Enzyme Pancreatin Powder, Umgubo we-Enzyme ye-Digestive Pancreatic, Ngemigangatho ephezulu yomgangatho wemveliso kunye nenkonzo, iimpahla zethu zithunyelwe kumazwe angaphezu kwama-25 njenge-USA, CANADA, GERMANY, FRANCE, UAE, Malaysia kunye nokunye.Sivuyiswe kakhulu ukukhonza abathengi abavela kulo lonke ilizwe. ihlabathi!

    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

    Sinesinye sezona zixhobo zivelisa izinto ezintsha, iinjineli ezinamava kunye nabaqeqeshiweyo kunye nabasebenzi, baqaphela iinkqubo zokuphatha ezisemgangathweni kunye neqela elinobuhlobo elinamava okufumana ingeniso phambi / emva kokuthengisa ngeXabiso loKhuphiswano lweChina iBanga lokuTya iPancreatin yeDigestion kunye neSatifikethi se-ISO ( I-CAS 8049-47-6), Ishishini lethu lakhula ngokukhawuleza ngobukhulu kunye nokuthandwa ngenxa yokuzinikela ngokupheleleyo kwimveliso ekumgangatho ophezulu, ixabiso elikhulu leemveliso kunye nomnikezeli wabathengi omangalisayo.
    Ixabiso loKhuphiswano lweChina Pancreatic Enzyme Pancreatin Powder, Umgubo we-Enzyme ye-Digestive Pancreatic, Ngemigangatho ephezulu yomgangatho wemveliso kunye nenkonzo, iimpahla zethu zithunyelwe kumazwe angaphezu kwama-27 njenge-USA, CANADA, GERMANY, FRANCE, UAE, Malaysia kunye nokunye.Sivuyiswe kakhulu ukukhonza abathengi abavela kulo lonke ilizwe. ihlabathi!


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