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Pancreatin yeDeebio ine Kugadzira Hupfu, Granule uye Pellet


  • Nhamba yeCAS:8049-47-6
  • HS CODE:3507.9090.90
  • Product Detail

    Product Tags

    Detail

    1. Hunhu: Pancreatin ipfumbu yakati rebei, amorphous powder kana kuti shava zvishoma kusvika kugranule yeruvara 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 hushoma, hupfu hweamorphous

    Hupfu hushoma, hupfu hweamorphous

    Hupfu hushoma, hupfu hweamorphous

    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

    1.05.2Ph.Eur.U/mg

    100450USP.U/mg

    Amylase

    ≥7000U/g

    12.080.0Ph.Eur.U/mg

    100500USP.U/mg

    Lipase

    ≥4000U/g

    15.0130Ph.Eur.U/mg

    1090USP.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


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