1. Characters: Pancreatin waa budo yar oo bunni ah, budo amorphous ah ama wax yar oo bunni ah ilaa midab kareem ah.Waxay ka kooban tahay amylase, lipase iyo protease.
2. Isha Soosaarka: Beeryarada Porcine.
3. habka: Pancreatin waxaa laga soosaaraa beeryarada doofaarka caafimaadka leh anagoo adeegsanayna tignoolajiyada firfircoonida-saarista.
4. Tilmaamaha iyo isticmaalka: Pancreatin waa isku-dar ah dhowr enzymes dheefshiidka oo ay soo saarto ganaca ee porcine.Waxaa loo isticmaali karaa warshadaha dawooyinka, diyaarinta cuntada, haragga, dhaqida iyo beeraha kale, oo leh noocyo kala duwan oo codsiyo ah.
Waxa lagu soo saaray aqoon-is-weydaarsiga GMP
· 27 sano oo enzyme bayooloji R&D taariikhda
Qalabka ceeriin waa la raadin karaa
U hoggaansamaan heerka macaamiisha
Dhoofinta in ka badan 30 waddan iyo gobollo
Inuu leeyahay awoodda maamulka 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 | |
dareere 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 | Proteine | ≥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 | |
wasakhda Microbial | TAMC | ≤ 10000cfu/g | ≤ 10000cfu/g | ≤ 10000cfu/g |
TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | waafaqsan | waafaqsan | waafaqsan | |
Salmonella | waafaqsan | waafaqsan | waafaqsan |