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Jumlo Warshada Daawada Graderaw Material Pancreatin ee Dheefshiidka oo wata Shahaadada GMP


  • Lambarka CAS:8049-47-6
  • HS code:3507.9090.90
  • Adeegga Faylka:Shiine-GMP/EU-GMP/DMF/EU-DMF
  • Heerka Pharmacopoeia:EP/USP/CP
  • Faahfaahinta Alaabta

    Tags Product

    Si aan kuu fududeyno oo aan u weyneyno shirkadeena, waxaan sidoo kale ku leenahay kormeerayaal kooxda QC waxaanan kuu xaqiijineynaa taageeradayada ugu weyn iyo badeecada ama adeegga Warshada Jumladeedka Caafimaadka Graderaw Material Pancreatin ee dheefshiidka oo wata Shahaadada GMP, Kuwa raacaya tayada Hi-, Hi-stable, Qaybaha qiimaha qallafsan, magaca ururka ayaa ah doorashadaada ugu weyn!
    Si aan kuu fududeyno oo aan u weyneyno shirkadeena, waxaan sidoo kale ku leenahay kormeerayaal kooxda QC ah oo aan kuu xaqiijino taageeradayada ugu weyn iyo badeecada ama adeegayadaShiineeska Pancreatic Budada Pankreatitin iyo Enzyme Budada Dheefshiidka, Waxaan u hoggaansamaan macmiilka 1st, tayada sare 1st, horumarinta joogtada ah, faa'iido wadaaga iyo mabaadi'da guul-guul.Marka lala kaashado macaamilka, waxaan siinaa dukaameeyaha adeeg tayo sare leh.Xiriir ganacsi oo wanaagsan oo la sameeyay anagoo adeegsanayna iibsadaha Zimbabwe gudaha ganacsiga, waxaan sameynay sumad iyo sumcad u gaar ah.Isla wakhtigaas, si kal iyo laab ah ku soo dhawoow rajada cusub iyo kuwii hore ee shirkadeena si ay u tagaan ugana xaajoodaan ganacsiyada yaryar.

    Faahfaahin

    1. Dabeecadaha: Pancreatin waa budo yar oo bunni ah, budo amorphous ah ama wax yar oo bunni ilaa midab kareem leh.Waxay ka kooban tahay amylase, lipase iyo protease.

    2. Isha Soosaarka: Beeryarada Porcine.

    3. habka: Pancreatin waxaa laga soo saaray beeryarada doofaarka caafimaadka qaba iyadoo la adeegsanayo tignoolajiyada firfircoonida-saarista.

    4. Tilmaamaha iyo isticmaalka: Pancreatin waa isku dhafka dhowr enzymes dheefshiidka oo ay soo saarto xameetida porcine.Waxaa loo isticmaali karaa warshadaha dawooyinka, diyaarinta cuntada, haragga, dhaqida iyo beeraha kale, oo leh codsiyo kala duwan.

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    Waa maxay sababta?

    Waxa lagu soo saaray aqoon-is-weydaarsiga GMP

    · 27 sano oo enzyme noole R&D taariikhda

    Walxaha ceeriin waa la raadin karaa

    U hoggaansamaan heerka macaamiisha

    Dhoofinta in ka badan 30 waddan iyo gobollo

    Inuu leeyahay awoodda maaraynta nidaamka tayada sida US FDA, Japan PMDA, South Korea MFDS, iwm.

    Tilmaamid

    Walxaha Tijaabada

    Tilmaamaha Shirkadda

    CP

    EP

    USP

    Jilayaasha

    Budada

    Wax yar oo bunni ah, budo amorphous ah

    Wax yar oo bunni ah, budo amorphous ah

    Wax yar oo bunni ah, budo amorphous ah

    Granule

    Granule wax yar ka brown ah oo midab kareem ah

    Granule wax yar ka brown ah oo midab kareem ah

    Granule wax yar ka brown ah oo midab kareem ah

    Aqoonsiga

    ————

    waafaqsan

    ————

    Tijaabooyin

    Dufanka ku jira

    ≤20mg/g

    ≤ 5.0%

    ≤3.0%(<3USP);≤ 6.0%(≥3USP)

    Luminta qalajinta

    ≤5.0% 105℃, 4saac

    ≤ 5.0% 670Pa 60℃, 4saac

    ≤ 5.0% Ku qallaji Vacuum 60℃, 4saac

    Walxaha haraaga ah

    ————

    ≤ 0.5% Marka loo eego EP(5.4)

    ≤ 0.5% Marka loo eego USP(467)

    Cabbirka walxaha

    ————

    Marka loo eego EP (2.1.4&2.9.12)

    Marka loo eego USP(811)

    Qiimayn

    Protease

    ≥600U/g

    1.0~5.2Ph.Eur.U/mg

    100~450USP.U/mg

    Amylase

    ≥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

    Waxyeellada Microbial

    TAMC

    ≤ 10000cfu/g

    ≤ 10000cfu/g

    ≤ 10000cfu/g

    TYMC

    ≤ 100cfu/g

    ≤ 100cfu/g

    ≤ 100cfu/g

    E.coli

    waafaqsan

    waafaqsan

    waafaqsan

    Salmonella

    waafaqsan

    waafaqsan

    waafaqsan

    Si aan kuu fududeyno oo aan u weyneyno shirkadeena, waxaan sidoo kale ku leenahay kormeerayaal kooxda QC waxaanan kuu xaqiijineynaa taageeradayada ugu weyn iyo badeecada ama adeegga Warshada Jumladeedka Caafimaadka Graderaw Material Pancreatin ee dheefshiidka oo wata Shahaadada GMP, Kuwa raacaya tayada Hi-, Hi-stable, Qaybaha qiimaha qallafsan, magaca ururka ayaa ah doorashadaada ugu weyn!
    Jumlo warshadeedShiineeska Pancreatic Budada Pankreatitin iyo Enzyme Budada Dheefshiidka, Waxaan u hoggaansamaan macmiilka 1st, tayada sare 1st, horumarinta joogtada ah, faa'iido wadaaga iyo mabaadi'da guul-guul.Marka lala kaashado macaamilka, waxaan siinaa dukaameeyaha adeeg tayo sare leh.Xiriir ganacsi oo wanaagsan oo la sameeyay anagoo adeegsanayna iibsadaha Zimbabwe gudaha ganacsiga, waxaan sameynay sumad iyo sumcad u gaar ah.Isla wakhtigaas, si kal iyo laab ah ku soo dhawoow rajada cusub iyo kuwii hore ee shirkadeena si ay u tagaan ugana xaajoodaan ganacsiyada yaryar.


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