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Pancreatin o Deebio me te hanga o te paura, te kirikiri me te pellet


  • Tau CAS:8049-47-6
  • Waehere HS:3507.9090.90
  • Ratonga Kōnae:Hainamana-GMP/EU-GMP/DMF/EU-DMF
  • Paerewa Pharmacopoeia:EP/USP/CP
  • Taipitopito Hua

    Tohu Hua

    Taipitopito

    1. Nga Tohu: Ko te Pancreatin he paku parauri, he paura amorphous, he paku parauri ranei ki te kirikiri kirikiri.Ko te amylase, te lipase me te protease.

    2. Puna Tangohanga: Porcine pancreas.

    3. te tukanga: Ka tangohia te Pancreatin mai i te pancreas poaka hauora e to tatou hangarau whakahohe-tangohanga motuhake.

    4 .Nga tohu me nga whakamahinga: Ko te Pancreatin he ranunga o te maha o nga whākōkī kūnatu i mahia e te pancreas o te porcine.Ka taea te whakamahi i roto i te ahumahi rongoa, te tukatuka kai, te tanning, te horoi me etahi atu mara, me te maha o nga tono.

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    Whakatakotoranga

    Nga Tuemi Whakamatau

    Whakatakotoranga Kamupene

    CP

    EP

    USP

    Ngā Pūāhua

    Paura

    He paura paku parauri, amorphous

    He paura paku parauri, amorphous

    He paura paku parauri, amorphous

    Granule

    He kirikiri paku parauri ki te kirikiri-tae

    He kirikiri paku parauri ki te kirikiri-tae

    He kirikiri paku parauri ki te kirikiri-tae

    Tautuhinga

    ————

    Ka rite

    ————

    Nga whakamatautau

    Ngako ngako

    ≤20mg/g

    ≤ 5.0%

    ≤3.0%(<3USP)≤ 6.0%(≥3USP)

    Ngaronga i te whakamaroke

    ≤5.0% 105℃, 4h

    ≤ 5.0% 670Pa 60 ℃, 4h

    ≤ 5.0%Maroke i roto i te korehau 60 ℃, 4h

    Te toenga whakarewa

    ————

    ≤ 0.5%E ai ki te EP(5.4)

    ≤ 0.5%E ai ki te USP(467)

    Te rahi o te matūriki

    ————

    E ai ki te EP(2.1.4&2.9.12)

    E ai ki te USP(811)

    Te whakamatautau

    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

    Nga poke moroiti

    TAMC

    ≤ 10000cfu/g

    ≤ 10000cfu/g

    ≤ 10000cfu/g

    TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    Ka rite

    Ka rite

    Ka rite

    Haramona

    Ka rite

    Ka rite

    Ka rite


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