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I-OEM China China Medical Graderaw Material Pancreatin for Digestion kunye ne-ISO Certificate (CAS 8049-47-6)


  • 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

    ngenxa yoncedo olugqwesileyo, iintlobo ngeentlobo zeemveliso ezikumgangatho ophezulu kunye nezisombululo, iindleko ezindlongondlongo kunye nonikezelo olusebenzayo, siyakuvuyela ukuthandwa okubalaseleyo phakathi kwabathengi bethu.Silishishini elinamandla kunye nemarike ebanzi ye-OEM China China Medical Graderaw Material Pancreatin for Digestion kunye neSatifikethi se-ISO (CAS 8049-47-6), Naziphi na iimfuno ezivela kuwe ziya kuhlawulwa ngengqwalasela yethu enkulu!
    ngenxa yoncedo olugqwesileyo, iintlobo ngeentlobo zeemveliso ezikumgangatho ophezulu kunye nezisombululo, iindleko ezindlongondlongo kunye nonikezelo olusebenzayo, siyakuvuyela ukuthandwa okubalaseleyo phakathi kwabathengi bethu.Sishishini elinamandla kunye nemarike ebanziChina Pancreatic Enzyme Pancreatin Powder, Umgubo wokugaya wePancreatic Enzyme, Ngamava ayo okuvelisa atyebileyo, iimveliso ezikumgangatho ophezulu kunye nezisombululo, kunye nenkonzo egqibeleleyo emva kokuthengiswa, inkampani iye yazuza igama elihle kwaye ibe yenye yeshishini elidumileyo elikhethekileyo kwi-series.Sinethemba elinyanisekileyo lokuseka ubudlelwane beshishini kunye nawe kwaye landelani inzuzo.

    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

    ngenxa yoncedo olugqwesileyo, iintlobo ngeentlobo zeemveliso ezikumgangatho ophezulu kunye nezisombululo, iindleko ezindlongondlongo kunye nonikezelo olusebenzayo, siyakuvuyela ukuthandwa okubalaseleyo phakathi kwabathengi bethu.Silishishini elinamandla kunye nemarike ebanzi ye-OEM China China Medical Graderaw Material Pancreatin for Digestion kunye neSatifikethi se-ISO (CAS 8049-47-6), Naziphi na iimfuno ezivela kuwe ziya kuhlawulwa ngengqwalasela yethu enkulu!
    OEM ChinaChina Pancreatic Enzyme Pancreatin Powder, Umgubo wokugaya wePancreatic Enzyme, Ngamava ayo okuvelisa atyebileyo, iimveliso ezikumgangatho ophezulu kunye nezisombululo, kunye nenkonzo egqibeleleyo emva kokuthengiswa, inkampani iye yazuza igama elihle kwaye ibe yenye yeshishini elidumileyo elikhethekileyo kwi-series.Sinethemba elinyanisekileyo lokuseka ubudlelwane beshishini kunye nawe kwaye landelani inzuzo.


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