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Ibicuruzwa

Ubwiza buhanitse bwa Pancreatin yo mu rwego rwo hejuru 8049-47-6 hamwe nigiciro cyiza GMP Icyemezo cyibicuruzwa


  • 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

    Twiyemeje gutanga agaciro gakomeye, ibicuruzwa bidasanzwe bifite ireme ryiza, kimwe no gutanga byihuse kubwiza buhanitse bwa Pancreatin yo mu rwego rwo hejuru 8049-47-6 hamwe nigiciro cyiza cya GMP Icyemezo cyibicuruzwa, Igurisha ryibiciro hamwe na serivise nziza kandi zishimishije bituma twinjiza abaguzi benshi cyane.twifuza gukorana nawe kandi dushakisha iterambere rusange.
    Twiyemeje gutanga agaciro gakomeye, ibicuruzwa bidasanzwe bifite ireme, kimwe no gutanga byihuseUbushinwa Pancreatin na 8049-47-6Twakomeje kwagura isoko muri Rumaniya usibye kwitegura gukubita ibicuruzwa byiza bihebuje bihujwe na printer ku ishati kugirango ubashe Romania.Abantu benshi bizera badashidikanya ko dufite ubushobozi bwose bwo kuguha ibisubizo bishimishije.

    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

    Twiyemeje gutanga agaciro gakomeye, ibicuruzwa bidasanzwe bifite ireme ryiza, kimwe no gutanga byihuse kubwiza buhanitse bwa Pancreatin yo mu rwego rwo hejuru 8049-47-6 hamwe nigiciro cyiza cya GMP Icyemezo cyibicuruzwa, Igurisha ryibiciro hamwe na serivise nziza kandi zishimishije bituma twinjiza abaguzi benshi cyane.twifuza gukorana nawe kandi dushakisha iterambere rusange.
    Ubuziranenge bwo hejuruUbushinwa Pancreatin na 8049-47-6Twakomeje kwagura isoko muri Rumaniya usibye kwitegura gukubita ibicuruzwa byiza bihebuje bihujwe na printer ku ishati kugirango ubashe Romania.Abantu benshi bizera badashidikanya ko dufite ubushobozi bwose bwo kuguha ibisubizo bishimishije.


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