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Ibicuruzwa bishya bishyushye Pancreatin (CAS No 8049-47-6) Uruganda rwa GMP rwamenyekanye


  • Umubare CAS:8049-47-6
  • Kode ya HS:3507.9090.90
  • Serivisi ya dosiye:Igishinwa-GMP / EU-GMP / DMF / EU-DMF
  • Ibipimo bya Pharmacopoeia:EP / USP / CP
  • Ibicuruzwa birambuye

    Ibicuruzwa

    Buri gihe tubona akazi ko kuba abakozi bifatika kugirango tumenye neza ko dushobora kuguha byoroshye ibyiza-byiza kandi byiza cyane kubicuruzwa bishya bishyushye Pancreatin (CAS No 8049-47-6) Uruganda rwa GMP rwabigenewe, Gusa kubigeraho ibicuruzwa byiza cyangwa serivisi nziza kugirango ibyo abakiriya bakeneye, ibicuruzwa byacu byose byagenzuwe neza mbere yo koherezwa.
    Buri gihe tubona akazi ko kuba abakozi bifatika kugirango tumenye neza ko dushobora kuguha byoroshye ibyiza-byiza kandi byiza cyane kuriUbushinwa Pancreatin na 8049-47-6, Mugukomeza guhanga udushya, tuzaguha ibintu byinshi na serivisi bifite agaciro, kandi tunatanga umusanzu mugutezimbere inganda zimodoka mugihugu ndetse no mumahanga.Abacuruzi bo mu gihugu ndetse n’abanyamahanga barahawe ikaze cyane kwifatanya natwe kugirango dukure hamwe.

    Ibisobanuro

    1. Inyuguti: Pancreatine ni umutuku wijimye, ifu ya amorphous cyangwa igikara gito kugeza kuri granule y'amabara.Igizwe na amylase, lipase na protease.

    2. Inkomoko yo gukuramo: pancreas pancreas.

    3. inzira: Pancreatine ikurwa muri pancreas nzima hamwe na tekinoroji yihariye yo gukuramo-gukuramo.

    4 .Ibyerekana no gukoresha: Pancreatin ni uruvange rw'imisemburo myinshi igogorwa na pancreas ya pcine.Irashobora gukoreshwa mu nganda zimiti, gutunganya ibiryo, gutunganya, gukaraba no mubindi bice, hamwe nibikorwa byinshi.

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    Kuki?

    · Yakozwe mu mahugurwa ya GMP

    · Imyaka 27 ya enzyme ya biologiya R&D amateka

    · Ibikoresho bibisi birashobora gukurikiranwa

    · Kurikiza amahame y'abakiriya

    · Kohereza mu bihugu n'uturere birenga 30

    · Ifite ubushobozi bwo gucunga neza sisitemu nka US FDA, Ubuyapani PMDA, Koreya yepfo MFDS, nibindi.

    Ibisobanuro

    Ibizamini

    Ibisobanuro bya sosiyete

    CP

    EP

    USP

    Inyuguti

    Ifu

    Ifu yijimye gato, ifu ya amorphous

    Ifu yijimye gato, ifu ya amorphous

    Ifu yijimye gato, ifu ya amorphous

    Granule

    Ibara ryijimye gato kugeza kuri cream-granule

    Ibara ryijimye gato kugeza kuri cream-granule

    Ibara ryijimye gato kugeza kuri cream-granule

    Kumenyekanisha

    ————

    Guhuza

    ————

    Ibizamini

    Ibinure

    ≤20mg / g

    ≤ 5.0%

    ≤3.0% (<3USP) ; ≤ 6.0% (≥3USP)

    Gutakaza kumisha

    ≤5.0% 105 ℃, 4h

    ≤ 5.0% 670Pa 60 ℃, 4h

    ≤ 5.0% Kuma muri Vacuum 60 ℃, 4h

    Ibisigisigi

    ————

    ≤ 0.5% Ukurikije EP (5.4)

    ≤ 0.5% Ukurikije USP (467)

    Ingano y'ibice

    ————

    Ukurikije EP (2.1.4 & 2.9.12)

    Ukurikije USP (811)

    Suzuma

    Kurinda

    00600U / g

    1.0 ~ 5.2Ph.Eur.U / mg

    100 ~ 450USP.U / mg

    Amylase

    0007000U / g

    12.0 ~ 80.0Ph.Eur.U / mg

    100 ~ 500USP.U / mg

    Lipase

    0004000U / g

    15.0 ~ 130Ph.Eur.U / mg

    10 ~ 90USP.U / mg

    Microbial Impurities

    TAMC

    ≤ 10000cfu / g

    ≤ 10000cfu / g

    ≤ 10000cfu / g

    TYMC

    C 100cfu / g

    C 100cfu / g

    C 100cfu / g

    E.coli

    Guhuza

    Guhuza

    Guhuza

    Salmonella

    Guhuza

    Guhuza

    Guhuza

    Buri gihe tubona akazi ko kuba abakozi bifatika kugirango tumenye neza ko dushobora kuguha byoroshye ibyiza-byiza kandi byiza cyane kubicuruzwa bishya bishyushye Pancreatin (CAS No 8049-47-6) Uruganda rwa GMP rwabigenewe, Gusa kubigeraho ibicuruzwa byiza cyangwa serivisi nziza kugirango ibyo abakiriya bakeneye, ibicuruzwa byacu byose byagenzuwe neza mbere yo koherezwa.
    Ibicuruzwa bishya bishyushyeUbushinwa Pancreatin na 8049-47-6, Mugukomeza guhanga udushya, tuzaguha ibintu byinshi na serivisi bifite agaciro, kandi tunatanga umusanzu mugutezimbere inganda zimodoka mugihugu ndetse no mumahanga.Abacuruzi bo mu gihugu ndetse n’abanyamahanga barahawe ikaze cyane kwifatanya natwe kugirango dukure hamwe.


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