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Ixabiso eliphantsi kakhulu elithembekileyo uMboneleli oPhezulu oPhezulu wePancreatin CAS 8049-47-6 ngeXabiso eliPhezulu


  • 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

    Ngoku sinabasebenzi abambalwa abagqwesileyo abathengi abalunge kakhulu kwintengiso kunye nentengiso, i-QC, kwaye sisebenza kunye neentlobo zengxaki enzima ngelixa sikwindlela yokudala yexabiso eliphantsi kakhulu elithembekileyo uMboneleli woMgangatho oPhezulu wePancreatin CAS 8049-47-6 ngeXabiso Elihle, Ukuba kufanelekile. uzingela umgangatho ophezulu, ukuhanjiswa ngokukhawuleza, okona kubaluleke kakhulu emva komboneleli kunye nomthengisi omkhulu weendleko e-China kwintsebenziswano yenkampani yexesha elide, siya kuba lolona khetho lwakho lusebenzayo.
    Ngoku sinabathengi abambalwa abagqwesileyo abagqwesileyo kwintengiso kunye nentengiso, i-QC, kwaye sisebenza kunye neentlobo zengxaki enzima ngelixa sikwindlela yokudala.I-China yeMichiza emihle kunye neMichiza yeMichiza yemihla ngemihla yeMathiriyeli ekrwada, Umgaqo wethu "yimfezeko kuqala, umgangatho ophezulu".Ngoku sinethemba lokubonelela ngenkonzo ebalaseleyo kunye neempahla ezifanelekileyo.Sithemba ngokunyanisekileyo ukuba singaseka intsebenziswano yokuphumelela ishishini nawe kwixesha elizayo!

    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

    Ngoku sinabasebenzi abambalwa abagqwesileyo abathengi abalunge kakhulu kwintengiso kunye nentengiso, i-QC, kwaye sisebenza kunye neentlobo zengxaki enzima ngelixa sikwindlela yokudala yexabiso eliphantsi kakhulu elithembekileyo uMboneleli woMgangatho oPhezulu wePancreatin CAS 8049-47-6 ngeXabiso Elihle, Ukuba kufanelekile. uzingela umgangatho ophezulu, ukuhanjiswa ngokukhawuleza, okona kubaluleke kakhulu emva komboneleli kunye nomthengisi omkhulu weendleko e-China kwintsebenziswano yenkampani yexesha elide, siya kuba lolona khetho lwakho lusebenzayo.
    Ixabiso eliphantsi kakhuluI-China yeMichiza emihle kunye neMichiza yeMichiza yemihla ngemihla yeMathiriyeli ekrwada, Umgaqo wethu "yimfezeko kuqala, umgangatho ophezulu".Ngoku sinethemba lokubonelela ngenkonzo ebalaseleyo kunye neempahla ezifanelekileyo.Sithemba ngokunyanisekileyo ukuba singaseka intsebenziswano yokuphumelela ishishini nawe kwixesha elizayo!


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