Kayayyaki
Pancreatin na Deebio tare da Formulation na Foda, Granule da Pellet
Daki-daki
1. Halaye: Pancreatin ɗan launin ruwan kasa ne, foda mai amorphous ko ɗan launin ruwan kasa zuwa granule mai launin kirim.Ya ƙunshi amylase, lipase da protease.
2. Tushen hakar: Porcine pancreas.
3. tsari: Ana fitar da Pancreatin daga lafiyayyen porcine pancreas ta hanyar fasahar cirewa na musamman.
4 .Alamomi da amfani: Pancreatin cakude ne na enzymes masu narkewa da yawa da ƙwayar porcine ke samarwa.Ana iya amfani dashi a cikin masana'antar harhada magunguna, sarrafa abinci, tanning, wankewa da sauran fannoni, tare da aikace-aikacen da yawa.
Me yasa mu?
· An yi shi a cikin taron GMP
· 27 shekaru na nazarin halittu enzyme R&D tarihi
Ana iya gano albarkatun kasa
· Bi daidaitattun abokin ciniki
· Fitarwa zuwa ƙasashe da yankuna sama da 30
Yana da ikon sarrafa tsarin inganci kamar US FDA, Japan PMDA, Koriya ta Kudu MFDS, da dai sauransu.
Ƙayyadaddun bayanai
| Kayan Gwaji | Ƙayyadaddun Kamfanin | |||
| CP | EP | USP | ||
| Halaye | Foda | Dan kadan launin ruwan kasa, foda amorphous | Dan kadan launin ruwan kasa, foda amorphous | Dan kadan launin ruwan kasa, foda amorphous |
| Granule | Dan kadan launin ruwan kasa zuwa granule mai launin kirim | Dan kadan launin ruwan kasa zuwa granule mai launin kirim | Dan kadan launin ruwan kasa zuwa granule mai launin kirim | |
| Ganewa | ———— | Ya dace | ———— | |
| Gwaji | Abun ciki mai kitse | ≤20mg/g | ≤ 5.0% | ≤3.0% (<3USP);≤ 6.0% (≥3USP) |
| Asarar bushewa | ≤5.0% 105℃, 4h | ≤ 5.0% 670Pa 60℃, 4h | ≤ 5.0% Bushewa a cikin Vacuum 60℃, 4h | |
| Ragowar sauran ƙarfi | ———— | ≤ 0.5% bisa ga EP (5.4) | ≤ 0.5% bisa ga USP(467) | |
| Girman barbashi | ———— | A cewar EP (2.1.4 & 2.9.12) | A cewar USP (811) | |
| Assay | 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 | |
| Najasa Na Ƙanƙara | TAMC | ≤ 10000cfu/g | ≤ 10000cfu/g | ≤ 10000cfu/g |
| Farashin TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g | |
| E.coli | Ya dace | Ya dace | Ya dace | |
| Salmonella | Ya dace | Ya dace | Ya dace | |
