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Pancreatin nke Deebio nwere nhazi ntụ ntụ, granule na pellet


  • Nọmba CAS:8049-47-6
  • Koodu HS:3507.9090.90
  • Ọrụ faịlụ:Chinese-GMP/EU-GMP/DMF/EU-DMF
  • Ọkọlọtọ Pharmacopoeia:EP/USP/CP
  • Nkọwa ngwaahịa

    Mkpado ngwaahịa

    Nkọwa

    1. Ihe odide: Pancreatin bụ obere aja aja, ntụ ntụ amorphous ma ọ bụ obere aja aja na granule na-acha ude.Ọ mejupụtara amylase, lipase na protease.

    2. Isi mmalite: Porcine pancreas.

    Usoro 3.: A na-ewepụta Pancreatin na pancreas nke ọma site na teknụzụ mwepu mwepu nke anyị.

    4 .Ngosipụta na ojiji: Pancreatin bụ ngwakọta nke ọtụtụ enzymes digestive nke pancreas na-emepụta.Enwere ike iji ya na ụlọ ọrụ ọgwụ, nhazi nri, tanning, ịsacha na mpaghara ndị ọzọ, yana ngwa ngwa dị iche iche.

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    Gịnị mere anyị?

    · Emepụtara na ogbako GMP

    · afọ 27 nke akụkọ ihe mere eme nke enzyme R&D

    · A na-achọpụta ihe ọkụkụ

    · Soro ọkọlọtọ ndị ahịa

    · Mbupụ gaa na mba na mpaghara iri atọ

    · Nwere ikike nke njikwa sistemụ dị mma dịka US FDA, Japan PMDA, South Korea MFDS, wdg.

    Nkọwapụta

    Nnwale ihe

    Nkọwapụta ụlọ ọrụ

    CP

    EP

    USP

    Ndị agwa

    Ntụ ntụ

    Obere agba aja aja, ntụ ntụ amorphous

    Obere agba aja aja, ntụ ntụ amorphous

    Obere agba aja aja, ntụ ntụ amorphous

    Granule

    Granule dị ntakịrị aja aja ruo ude

    Granule dị ntakịrị aja aja ruo ude

    Granule dị ntakịrị aja aja ruo ude

    njirimara

    ————

    Dabara

    ————

    Nnwale

    Ọdịnaya abụba

    ≤20mg/g

    ≤5.0%

    ≤3.0% (<3USP);≤ 6.0% (≥3USP)

    Ọnwụ na ihicha

    ≤5.0% 105℃, 4h

    ≤ 5.0% 670Pa 60℃, 4h

    ≤ 5.0% Akọrọ na Vacuum 60℃, 4h

    Ihe mgbaze fọdụrụnụ

    ————

    ≤ 0.5% Dị ka EP (5.4) si kwuo

    ≤ 0.5% Dị ka USP (467) si kwuo

    Nha urughuru

    ————

    Dabere na EP (2.1.4 & 2.9.12)

    Dabere na USP (811)

    Nyocha

    Mgbochi

    ≥600U/g

    1.05.2 Ph.Eur.U/mg

    100450USP.U/mg

    Amylase

    ≥7000U/g

    12.080.0Ph.Eur.U/mg

    100500USP.U/mg

    Lipase

    ≥4000U/g

    15.0130 Ph.Eur.U/mg

    1090USP.U/mg

    Microbial adịghị ọcha

    TAMC

    ≤10000cfu/g

    ≤10000cfu/g

    ≤10000cfu/g

    TYMC

    ≤100cfu/g

    ≤100cfu/g

    ≤100cfu/g

    E.coli

    Dabara

    Dabara

    Dabara

    Salmonella

    Dabara

    Dabara

    Dabara


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