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OEM Factory yeChikafu Giredhi Raw Material Pancreatin yeDigestion ine GMP Chitupa


  • Nhamba yeCAS:8049-47-6
  • HS CODE:3507.9090.90
  • Faira Service:Chinese-GMP/EU-GMP/DMF/EU-DMF
  • Pharmacopoeia standard:EP/USP/CP
  • Product Detail

    Product Tags

    Yepamusoro-soro inouya yekutanga;rubatsiro rwuri pamberi;bhizinesi bhizinesi kubatana ”ndihwo huzivi hwebhizinesi redu rinogara richicherechedzwa uye kuteverwa nebhizinesi redu reOEM Factory yeChikafu Giredhi Raw Material Pancreatin yeDigestion ine GMP Chitupa, Isu tinotora basa rinotungamira mukupa vatengi zvinhu zvakanaka zvemhando yepamusoro mupi uye ane hukasha. mhosva.
    Yepamusoro-soro inouya yekutanga;rubatsiro rwuri pamberi;bhizinesi bhizinesi kushandira pamwe ”ndihwo huzivi hwebhizinesi rebhizinesi iro rinogara richicherechedzwa uye richiteverwa nebhizinesi reduChina Pancreatic Enzyme Pancreatin Powder uye Digestive Pancreatic Enzyme Powder, Zvigadzirwa zvedu zvinotengeswa kunze kwenyika.Vatengi vedu vanogara vachigutsikana nemhando yedu yakavimbika, masevhisi anotungamirwa nevatengi uye mitengo yemakwikwi.Basa redu ndere "kuenderera mberi nekuwana kuvimbika kwako nekuzvipira kuedza kwedu mukuvandudza nguva dzose kwezvigadzirwa nemasevhisi edu kuitira kuti tive nechokwadi chekugutsikana kwevashandisi vedu vekupedzisira, vatengi, vashandi, vatengesi uye nharaunda dzepasirese dzatinobatirana".

    Detail

    1. Hunhu: Pancreatin ipfumbu yakati rebei, amorphous poda kana kuti shava zvishoma kune granule ine ruvara rwekrimu.Iyo inoumbwa neamylase, lipase uye protease.

    2. Kubvisa Kunobva: Porcine pancreas.

    3. maitiro: Pancreatin inotorwa kubva kune ine hutano porcine pancreas neyedu chete activation-extraction tekinoroji.

    4 .Zviratidzo uye kushandiswa: Pancreatin musanganiswa wema enzymes akawanda ekugaya anogadzirwa nepancreas yenguruve.Inogona kushandiswa muindasitiri yemishonga, kugadzira chikafu, kusukwa, kuwacha nemimwe minda, ine huwandu hwakawanda hwekushandisa.

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    Sei isu?

    · Yakagadzirwa muGMP musangano

    · Makore makumi maviri nemanomwe ebhayoloji enzyme R&D nhoroondo

    ·Maraw materials anotarisika

    ·Kutevedzera mwero wevatengi

    ·Tumira kunze kwenyika dzinopfuura makumi matatu nematunhu

    ·Ane kugona kwemhando yekutonga system seUS FDA, Japan PMDA, South Korea MFDS, nezvimwe.

    Tsanangudzo

    Test Items

    Kutsanangurwa kwekambani

    CP

    EP

    USP

    Vanhu

    Upfu

    Hupfu hwakasvibira zvishoma, amorphous

    Hupfu hwakasvibira zvishoma, amorphous

    Hupfu hwakasvibira zvishoma, amorphous

    Granule

    Granule ine ruvara rutsvuku zvishoma kune runyoro

    Granule ine ruvara rutsvuku zvishoma kune runyoro

    Granule ine ruvara rutsvuku zvishoma kune runyoro

    Identification

    ————

    Conforms

    ————

    Miedzo

    Mafuta emukati

    ≤20mg/g

    ≤ 5.0%

    ≤3.0%(<3USP);≤ 6.0%(≥3USP)

    Kurasikirwa pakuomeswa

    ≤5.0% 105℃, 4h

    ≤ 5.0% 670Pa 60℃, 4h

    ≤ 5.0%Dry in Vacuum 60℃, 4h

    Residual solvent

    ————

    ≤ 0.5%Maererano neEP(5.4)

    ≤ 0.5%Maererano neUSP(467)

    Chikamu saizi

    ————

    Zvinoenderana neEP(2.1.4&2.9.12)

    Maererano neUSP(811)

    Assay

    Protease

    ≥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

    Kusvibiswa kweMicrobial

    TAMC

    ≤ 10000cfu/g

    ≤ 10000cfu/g

    ≤ 10000cfu/g

    TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Conforms

    Conforms

    Conforms

    Salmonella

    Conforms

    Conforms

    Conforms

    Yepamusoro-soro inouya yekutanga;rubatsiro rwuri pamberi;bhizinesi bhizinesi kubatana ”ndihwo huzivi hwebhizinesi redu rinogara richicherechedzwa uye kuteverwa nebhizinesi redu reOEM Factory yeChikafu Giredhi Raw Material Pancreatin yeDigestion ine GMP Chitupa, Isu tinotora basa rinotungamira mukupa vatengi zvinhu zvakanaka zvemhando yepamusoro mupi uye ane hukasha. mhosva.
    OEM Factory yeChina Pancreatic Enzyme Pancreatin Powder uye Digestive Pancreatic Enzyme Powder, Zvigadzirwa zvedu zvinotengeswa kunze kwenyika.Vatengi vedu vanogara vachigutsikana nemhando yedu yakavimbika, masevhisi anotungamirwa nevatengi uye mitengo yemakwikwi.Basa redu ndere "kuenderera mberi nekuwana kuvimbika kwako nekuzvipira kuedza kwedu mukuvandudza nguva dzose kwezvigadzirwa nemasevhisi edu kuitira kuti tive nechokwadi chekugutsikana kwevashandisi vedu vekupedzisira, vatengi, vashandi, vatengesi uye nharaunda dzepasirese dzatinobatirana".


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