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Ubonelelo lweOEM China CAS 8049-47-6 Enzyme Powder Pancreatin elona xabiso lilungileyo


  • 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

    Amaziko ethu axhotyiswe ngokufanelekileyo kunye nomgangatho ophezulu wolawulo oluphezulu kuzo zonke izigaba zesizukulwana kusenza ukuba siqinisekise ulwaneliseko lomthengi olupheleleyo lwe-OEM Supply China CAS 8049-47-6 Enzyme Powder Pancreatin ngeXabiso Elihle, Siyakwamkela ukuba ngokuqinisekileyo undwendwele iyunithi yethu yokuvelisa. kwaye ulindele ukudala ubudlelwane bombutho owamkelayo kunye nabathengi endlwini yakho naphesheya kolwandle ngaphakathi kufutshane nekamva elibonakalayo.
    Amaziko ethu axhotyiswe kakuhle kunye nolawulo olukumgangatho ophezulu obalaseleyo kuzo zonke izigaba zesizukulwana sisenza ukuba siqinisekise ukoneliseka komthengi ngokupheleleyoPancreatin yaseTshayina, Ukongezwa kokutya, Ngamava aphantse abe ngama-30 kwishishini, siqinisekile ngenkonzo ekumgangatho ophezulu, umgangatho kunye nokuhanjiswa.Samkela ngokufudumeleyo abathengi abavela kwihlabathi liphela ukusebenzisana nenkampani yethu kuphuhliso olufanayo.

    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

    Amaziko ethu axhotyiswe ngokufanelekileyo kunye nomgangatho ophezulu wolawulo oluphezulu kuzo zonke izigaba zesizukulwana kusenza ukuba siqinisekise ulwaneliseko lomthengi olupheleleyo lwe-OEM Supply China CAS 8049-47-6 Enzyme Powder Pancreatin ngeXabiso Elihle, Siyakwamkela ukuba ngokuqinisekileyo undwendwele iyunithi yethu yokuvelisa. kwaye ulindele ukudala ubudlelwane bombutho owamkelayo kunye nabathengi endlwini yakho naphesheya kolwandle ngaphakathi kufutshane nekamva elibonakalayo.
    Ubonelelo lweOEMPancreatin yaseTshayina, Ukongezwa kokutya, Ngamava aphantse abe ngama-30 kwishishini, siqinisekile ngenkonzo ekumgangatho ophezulu, umgangatho kunye nokuhanjiswa.Samkela ngokufudumeleyo abathengi abavela kwihlabathi liphela ukusebenzisana nenkampani yethu kuphuhliso olufanayo.


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