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Hunhu Hwepamusoro hwePancreatin 8049-47-6 ine Mutengo Unonzwisisika GMP Chigadzirwa Chetifiketi


  • 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

    Isu tanga takazvipira kupa hukasha hunokosha, zvinhu zvakasarudzika zvemhando yepamusoro, sezvakangoita kukurumidza kuendesa Yemhando yepamusoro Pancreatin 8049-47-6 ine Inonzwisisika Mutengo GMP Setifiketi Chigadzirwa, Hukasha kutengesa mutengo nemhando yepamusoro uye masevhisi anogutsa anoita kuti tiwane. vateki vakawanda.tinoda kushanda newe uye kutsvaga kuvandudzwa kwakafanana.
    Isu tanga takazvipira kupa hukasha kukosha, yakasarudzika zvinhu zvakanaka mhando, zvakafanana nekukasira kuendesa kune.China Pancreatin uye 8049-47-6, Isu tanga tichigara tichiwedzera musika mukati meRomania pamwe nekugadzirira kubaya mune zvekuwedzera zvemhando yepamusoro zvekutengesa zvakabatana neprinta pat shirt kuitira kuti iwe ugone Romania.Vanhu vazhinji vanotenda zvakasimba kuti tine simba rose rekukupa mhinduro dzinofadza.

    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

    Isu tanga takazvipira kupa hukasha hunokosha, zvinhu zvakasarudzika zvemhando yepamusoro, sezvakangoita kukurumidza kuendesa Yemhando yepamusoro Pancreatin 8049-47-6 ine Inonzwisisika Mutengo GMP Setifiketi Chigadzirwa, Hukasha kutengesa mutengo nemhando yepamusoro uye masevhisi anogutsa anoita kuti tiwane. vateki vakawanda.tinoda kushanda newe uye kutsvaga kuvandudzwa kwakafanana.
    High Quality forChina Pancreatin uye 8049-47-6, Isu tanga tichigara tichiwedzera musika mukati meRomania pamwe nekugadzirira kubaya mune zvekuwedzera zvemhando yepamusoro zvekutengesa zvakabatana neprinta pat shirt kuitira kuti iwe ugone Romania.Vanhu vazhinji vanotenda zvakasimba kuti tine simba rose rekukupa mhinduro dzinofadza.


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