Qalabkayaga si fiican u qalabaysan iyo nidaaminta tayada wanaagsan ee dhammaan heerarka wax soo saarka ayaa noo suurtagelinaya in aan dammaanad qaadno ku qanacsanaanta iibsadaha ee qiimo dhimista Weyn ee Qalabka Ceyriinka ee Pharmaceutical Pancreatin CAS 8049-47-6 alaabta iyo adeegyada dhaqaale.
Qalabkayaga oo si fiican u qalabaysan iyo nidaaminta tayada wanaagsan ee dhammaan heerarka wax soo saarka ayaa noo suurtageliya inaan dammaanad qaadno wadarta ku qanacsanaanta iibsadahaShiinaha Pancreatin iyo Pancreatin Powder, Shirkadeena waxay ku shaqeyneysaa mabda'a hawlgalka "xunnimo ku salaysan, iskaashiga abuuray, dadka u janjeedha, iskaashiga guul-guul".Waxaan rajeyneynaa inaan xiriir saaxiibtinimo la yeelan karno ganacsatada adduunka oo dhan.
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.
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.
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 |
Qalabkayaga si fiican u qalabaysan iyo nidaaminta tayada wanaagsan ee dhammaan heerarka wax soo saarka ayaa noo suurtagelinaya in aan dammaanad qaadno ku qanacsanaanta iibsadaha ee qiimo dhimista Weyn ee Qalabka Ceyriinka ee Pharmaceutical Pancreatin CAS 8049-47-6 alaabta iyo adeegyada dhaqaale.
qiimo dhimis weynShiinaha Pancreatin iyo Pancreatin Powder, Shirkadeena waxay ku shaqeyneysaa mabda'a hawlgalka "xunnimo ku salaysan, iskaashiga abuuray, dadka u janjeedha, iskaashiga guul-guul".Waxaan rajeyneynaa inaan xiriir saaxiibtinimo la yeelan karno ganacsatada adduunka oo dhan.