• Iimveliso
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Iimveliso

Umzi-mveliso ubonelela ngokuthe ngqo eChina Ucoceko lweMathiriyeli eRaw Pancreatin/Pancreatic Enzyme/Izithako zePharma ezisebenzayo


  • 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

    Ugxininiso lwethu kufuneka lube kukuhlanganisa kunye nokuphucula umgangatho kunye nokulungiswa kweemveliso zangoku, okwangoku sihlala siseka iimveliso ezintsha ukuhlangabezana neemfuno zabathengi abakhethekileyo kwiFactory Ukubonelela ngokuthe ngqo iChina Purity Raw Material Pancreatin/I-Pancreatic Enzyme/Izithako ze-Pharma eziSebenzayo, iLebhu yethu ngoku “yiLebhu yeSizwe ye-turbo ye-injini ye-diesel ” , kwaye singabasebenzi abaqeqeshiweyo be-R&D kunye neziko lovavanyo elipheleleyo.
    Ugxininiso lwethu kufuneka lube kukuhlanganisa kunye nokuphucula umgangatho kunye nokulungiswa kweemveliso zangoku, okwangoku sihlala siseka iimveliso ezintsha ukuhlangabezana neemfuno zabathengi abakhethekileyoPancreatin yaseTshayina, I-Pancreatic Enzyme, Zonke iimpahla zethu zithunyelwa kumazwe angaphandle kubathengi base-UK, eJamani, eFransi, eSpain, e-USA, eKhanada, e-Iran, e-Iraq, kuMbindi Mpuma nase-Afrika.Iimveliso zethu kunye nezisombululo zamkelwe kakuhle ngabaxumi bethu ngomgangatho ophezulu, amaxabiso akhuphisanayo kunye nezona ndlela zilungileyo.Sinethemba lokuseka ubudlelwane beshishini nabo bonke abathengi kwaye sizise imibala emihle ngakumbi ebomini.

    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

    Sinikezela ngokuthe ngqoPancreatin yaseTshayina, I-Pancreatic Enzyme, Zonke iimpahla zethu zithunyelwa kumazwe angaphandle kubathengi base-UK, eJamani, eFransi, eSpain, e-USA, eKhanada, e-Iran, e-Iraq, kuMbindi Mpuma nase-Afrika.Iimveliso zethu kunye nezisombululo zamkelwe kakuhle ngabaxumi bethu ngomgangatho ophezulu, amaxabiso akhuphisanayo kunye nezona ndlela zilungileyo.Sinethemba lokuseka ubudlelwane beshishini nabo bonke abathengi kwaye sizise imibala emihle ngakumbi ebomini.


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