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Pancreatin de Deebio cum Formula Pulvis, Granule et Pellet'


  • CAS Number:8049-47-6
  • HS CODEX:3507.9090.90
  • Tabularium Service:Seres-GMP/EU-GMP/DMF/EU-DMF
  • Pharmacopoeia vexillum:EP/USP/CP
  • Product Detail

    Product Tags

    Detail

    1. Characteres: Pancreatinus est subrubra, amorphosus pulvis vel paulo brunneus ad granulum crepis-coloratum.Componitur ex amylase, lipase et protease.

    2. Extraction Source: Pancreas Porcine.

    3. processum: Pancreatinum e pancreate porcino sano extractum per technologiam nostram exclusivam activationis-extractionis.

    4 .Indicationes et usus: Pancreatin est mixtura plurium enzymorum digestivorum a pancreate porcino productorum.Adhiberi potest in pharmaceutica industria, processus cibi, tanning, lavacro et aliis campis, amplis applicationibus.

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    quare nos?

    · Produci in officina GMP

    · XXVII annos biologicos enzyme R&D history

    · Rudis materia deprauationis

    · parere mos vexillum

    · Export ut supra XXX regiones et regiones

    · Facultatem administrationis qualitatis habet ut FDA, Iaponia PMDA, Corea Meridiana MFDS, etc.

    Specification

    Test Items

    Societas Specification

    CP

    EP

    USP

    Characteres

    Pulvis

    A leviter brunneis, amorpho pulveris

    A leviter brunneis, amorpho pulveris

    A leviter brunneis, amorpho pulveris

    Granule

    A leviter brunneis usque ad granulum GILVUS

    A leviter brunneis usque ad granulum GILVUS

    A leviter brunneis usque ad granulum GILVUS

    Lepidium sativum

    ----

    Conforms

    ----

    Tests

    Adipem content

    ≤20mg/g*

    ≤ 5.0%

    ≤3.0%(<3USP).≤ 6.0%(≥3USP)

    Damnum in siccitate

    ≤5.0% 105℃, 4h

    ≤ 5.0% 670Pa 60℃, 4h

    ≤ 5.0% Siccare in Vacuo 60℃, 4h

    RELICTUM solvendo

    ----

    ≤ 0.5% Secundum EP (5.4)

    ≤ 0.5% Secundum USP (467)

    Magnitudo particula

    ----

    Secundum EP(2.1.4&2.9.12)

    Secundum USP (DCCCXI)

    Assay

    Protease

    ≥600U/g

    1.0~5.2Ph.Eur.U/mg

    100~450USP.U/mg

    Lumbricus

    ≥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

    Microbial immunditias

    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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