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Umgangatho oPhezulu woMgangatho oPhezulu wePancreatin 8049-47-6 ngexabiso elifanelekileyo iMveliso yeSatifikethi seGMP


  • 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

    Sizibophelele ekunikezeni ixabiso elinobundlongondlongo, iimpahla ezikhethekileyo ezisemgangathweni olungileyo, ngokunjalo nokuhanjiswa okukhawulezayo koMgangatho oPhezulu woMgangatho oPhezulu wePancreatin 8049-47-6 ngeXabiso eliQhelekileyo leMveliso yeSatifikethi se-GMP, ixabiso elithengisiweyo elinobundlongondlongo elinomgangatho ophezulu kunye neenkonzo ezanelisayo zisenza sizuze. abathengi abaninzi.sinqwenela ukusebenza kunye nawe kwaye sijonge uphuculo olufanayo.
    Sizibophelele ekunikezeni ixabiso elinobundlobongela, iimpahla ezikhethekileyo ezisemgangathweni, ngokunjalo nokuhanjiswa ngokukhawulezaChina Pancreatin kunye 8049-47-6, Besithe gqolo sandisa imarike ngaphakathi eRomania ukongeza ekulungiseleleni ukuthengisa izinto ezikumgangatho ophezulu ezidityaniswe nomshicileli kwit shirt ukuze ukwazi eRomania.Uninzi lwabantu lukholelwa ngokuqinileyo ukuba sinakho konke ukukunika izisombululo ezonwabileyo.

    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

    Sizibophelele ekunikezeni ixabiso elinobundlongondlongo, iimpahla ezikhethekileyo ezisemgangathweni olungileyo, ngokunjalo nokuhanjiswa okukhawulezayo koMgangatho oPhezulu woMgangatho oPhezulu wePancreatin 8049-47-6 ngeXabiso eliQhelekileyo leMveliso yeSatifikethi se-GMP, ixabiso elithengisiweyo elinobundlongondlongo elinomgangatho ophezulu kunye neenkonzo ezanelisayo zisenza sizuze. abathengi abaninzi.sinqwenela ukusebenza kunye nawe kwaye sijonge uphuculo olufanayo.
    Umgangatho ophezulu weChina Pancreatin kunye 8049-47-6, Besithe gqolo sandisa imarike ngaphakathi eRomania ukongeza ekulungiseleleni ukuthengisa izinto ezikumgangatho ophezulu ezidityaniswe nomshicileli kwit shirt ukuze ukwazi eRomania.Uninzi lwabantu lukholelwa ngokuqinileyo ukuba sinakho konke ukukunika izisombululo ezonwabileyo.


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