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Iimveliso

Ukubonelelwa ngoMgangatho oPhezulu woMsebenzi we-Enzyme Powder Pancreatin


  • 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

    ukuqhubeka nokuphucula, ukuba sisisombululo esithile siphezulu ngokuhambelana neemfuno zomgangatho wentengiso kunye nomthengi.Inkampani yethu inenkqubo yoqinisekiso ebalaseleyo eneneni isekwe kuMgangatho oLungileyo woBonelelo oluPhezulu loMsebenzi we-Enzyme Powder Pancreatin, kwaye kukho abahlobo abambalwa bamazwe aphesheya abeze kubona, okanye basiphathise ukubathengela ezinye izinto.Ungamkeleka kakhulu ukuba ufike eTshayina, kwisixeko sethu nakwifektri yethu!
    ukuqhubeka nokuphucula, ukuba sisisombululo esithile siphezulu ngokuhambelana neemfuno zomgangatho wentengiso kunye nomthengi.Inkampani yethu inenkqubo yoqinisekiso egqwesileyo emiselwe yonaChina Material Pancreatin kunye Enzyme Powder Pancreatin, Iqela lethu lobunjineli bezakhono liya kuhlala likulungele ukukusebenzela ukubonisana kunye nempendulo.Siyakwazi ukukunika iisampulu zasimahla zokuhlangabezana neemfuno zakho.Iinzame ezigqwesileyo ziya kuveliswa ukukunika inkonzo efanelekileyo kunye neemveliso.Nabani na ocinga ngenkampani yethu kunye nentengiso, khumbula ukunxibelelana nathi ngokusithumelela ii-imeyile okanye uqhagamshelane nathi ngokukhawuleza.Njengendlela yokwazi ukuthengisa kwethu kunye nokuqina.okuninzi ngakumbi, ungaza kumzi-mveliso wethu ukuze ufumane oko.Siya kuhlala sisamkela iindwendwe ezivela kwihlabathi liphela kwishishini lethu ukuze sakhe ubudlelwane benkampani nathi.Qiniseka ukuba uziva ukhululekile ukunxibelelana nathi ngeshishini kwaye sikholelwa ukuba siza kwabelana ngamava aphezulu asebenzayo kunye nabo bonke abarhwebi bethu.

    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

    ukuqhubeka nokuphucula, ukuba sisisombululo esithile siphezulu ngokuhambelana neemfuno zomgangatho wentengiso kunye nomthengi.Inkampani yethu inenkqubo yoqinisekiso ebalaseleyo eneneni isekwe kuMgangatho oLungileyo woBonelelo oluPhezulu loMsebenzi we-Enzyme Powder Pancreatin, kwaye kukho abahlobo abambalwa bamazwe aphesheya abeze kubona, okanye basiphathise ukubathengela ezinye izinto.Ungamkeleka kakhulu ukuba ufike eTshayina, kwisixeko sethu nakwifektri yethu!
    Umgangatho olungileyoChina Material Pancreatin kunye Enzyme Powder Pancreatin, Iqela lethu lobunjineli bezakhono liya kuhlala likulungele ukukusebenzela ukubonisana kunye nempendulo.Siyakwazi ukukunika iisampulu zasimahla zokuhlangabezana neemfuno zakho.Iinzame ezigqwesileyo ziya kuveliswa ukukunika inkonzo efanelekileyo kunye neemveliso.Nabani na ocinga ngenkampani yethu kunye nentengiso, khumbula ukunxibelelana nathi ngokusithumelela ii-imeyile okanye uqhagamshelane nathi ngokukhawuleza.Njengendlela yokwazi ukuthengisa kwethu kunye nokuqina.okuninzi ngakumbi, ungaza kumzi-mveliso wethu ukuze ufumane oko.Siya kuhlala sisamkela iindwendwe ezivela kwihlabathi liphela kwishishini lethu ukuze sakhe ubudlelwane benkampani nathi.Qiniseka ukuba uziva ukhululekile ukunxibelelana nathi ngeshishini kwaye sikholelwa ukuba siza kwabelana ngamava aphezulu asebenzayo kunye nabo bonke abarhwebi bethu.


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