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Alaabta

Warshada OEM ee Qalab Ceyriin ah oo Qalab ah oo loogu talagalay 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

    Tayada sare waxay timaadaa 1aad;caawimada ayaa ugu horraysa;ganacsiga ganacsiga waa iskaashiga" waa falsafada ganacsiga our ganacsiga kaas oo si joogto ah loo arkay oo ay eryan by our ganacsi for OEM Warshadda for Food Fasalka Raw Material Pancreatin ee dheefshiidka la Shahaadada GMP, Waxaan ka ciyaarnaa door hoggaamineed in qalabaynta macaamiisha alaab tayo wanaagsan bixiye weyn iyo dagaal badan. eedeymaha.
    Tayada sare waxay timaadaa 1aad;caawimada ayaa ugu horraysa;ganacsiga ganacsigu waa iskaashi" waa falsafada ganacsiga ganacsiga taas oo si joogto ah loo arkay oo ay ku raad by ganacsigeenuShiineeska Pancreatic Budada Pankreatitin iyo Enzyme Budada Dheefshiidka, Badeecadahayaga waxaa loo dhoofiyaa adduunka oo dhan.Macaamiishayadu waxay had iyo jeer ku qanacsan yihiin tayadayada la isku halayn karo, adeegyada macaamiisha ku jihaysan iyo qiimaha tartanka.Hadafkayagu waa "inaan sii wadno si aan u kasbano daacadnimadaada anagoo u hurayna dadaalkeena horumarinta joogtada ah ee alaabtayada iyo adeegyadayada si aan u hubinno qanacsanaanta isticmaalayaashayada, macaamiisheena, shaqaalaha, alaab-qeybiyeyaasha iyo bulshooyinka caalamka ee aan iska kaashano".

    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

    Tayada sare waxay timaadaa 1aad;caawimada ayaa ugu horraysa;ganacsiga ganacsiga waa iskaashiga" waa falsafada ganacsiga our ganacsiga kaas oo si joogto ah loo arkay oo ay eryan by our ganacsi for OEM Warshadda for Food Fasalka Raw Material Pancreatin ee dheefshiidka la Shahaadada GMP, Waxaan ka ciyaarnaa door hoggaamineed in qalabaynta macaamiisha alaab tayo wanaagsan bixiye weyn iyo dagaal badan. eedeymaha.
    Warshada OEM eeShiineeska Pancreatic Budada Pankreatitin iyo Enzyme Budada Dheefshiidka, Badeecadahayaga waxaa loo dhoofiyaa adduunka oo dhan.Macaamiishayadu waxay had iyo jeer ku qanacsan yihiin tayadayada la isku halayn karo, adeegyada macaamiisha ku jihaysan iyo qiimaha tartanka.Hadafkayagu waa "inaan sii wadno si aan u kasbano daacadnimadaada anagoo u hurayna dadaalkeena horumarinta joogtada ah ee alaabtayada iyo adeegyadayada si aan u hubinno qanacsanaanta isticmaalayaashayada, macaamiisheena, shaqaalaha, alaab-qeybiyeyaasha iyo bulshooyinka caalamka ee aan iska kaashano".


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