O a matou fale faʻapipiʻi lelei ma sili lelei lelei faʻatonutonu i laʻasaga uma o le gaosiga e mafai ai ona matou faʻamaonia le faʻamalieina o le au faʻatau mo le faʻaitiitiga tele o Pharmaceutical Raw Materials Powder Pancreatin CAS 8049-47-6, Matou te folafola atu e taumafai i le mea sili e laveaʻiina oe i le tulaga maualuga ma oloa ma auaunaga tau tamaoaiga.
O a matou fale faʻapipiʻi lelei ma le lelei lelei e faʻatonutonu i laʻasaga uma o gaosiga e mafai ai ona matou faʻamaonia le faamalieina atoa o tagata faʻatau moSaina Pancreatin ma Pancreatin Powder, O loʻo galue la matou kamupani i le faʻatonuga o le "faʻamaoni-faʻavae, galulue faʻatasi, faʻavae tagata, manumalo-manumalo galulue faatasi".Matou te faʻamoemoe e mafai ona matou maua se mafutaga faauo ma tagata fai pisinisi mai le lalolagi atoa.
1. Uiga: Pancreatin e la'ititi enaena, efuefu pa'u po'o enaena enaena i le kulimi-lanu pa'u.E aofia ai amylase, lipase ma protease.
2. Punavai Aveesea: Porcine pancreas.
3. fa'agaioiga: O le Pancreatin e maua mai le pancreas porcine maloloina e ala i la tatou fa'atekonolosi fa'ato'aga-fa'aoso.
4 . Fa'ailoga ma fa'aoga: Pancreatin o se fa'afefiloi o le tele o enzymes fa'amamago e gaosia e le pancreas o pua'a.E mafai ona faʻaaogaina i le falemaʻi falemaʻi, gaosiga o meaʻai, tanning, fufuluina ma isi fanua, faʻatasi ai ma le tele o faʻaoga.
· Faia i le aʻoga GMP
· 27 tausaga o biological enzyme R&D talafaasolopito
· E mafai ona su'eina mea mata'utia
· Ia tausisia tulaga fa'atau
· Auina atu i fafo i le silia ma le 30 atunuu ma itulagi
· O loʻo i ai le gafatia o pulega lelei faʻapitoa e pei ole US FDA, Iapani PMDA, Korea i Saute MFDS, ma isi.
Mea Su'ega | Kamupani Fa'amatalaga | |||
CP | EP | USP | ||
Uiga | Pauta | Ose pauta enaena enaena, amorphous | Ose pauta enaena enaena, amorphous | Ose pauta enaena enaena, amorphous |
Granule | Ose pa'u enaena enaena i le kulimi | Ose pa'u enaena enaena i le kulimi | Ose pa'u enaena enaena i le kulimi | |
Fa'ailoaga | ———— | Fa'atatau | ———— | |
Su'ega | mea ga'o | ≤20mg/g | ≤ 5.0% | ≤3.0%(<3USP);≤ 6.0%(≥3USP) |
Ma'imau ile fa'amago | ≤5.0% 105℃, 4h | ≤ 5.0% 670Pa 60℃, 4h | ≤ 5.0% Fa'amamago i le Vacuum 60℃, 4h | |
Soli totoe | ———— | ≤ 0.5%E tusa ai ma le EP(5.4) | ≤ 0.5%E tusa ai ma le USP(467) | |
Lapopo'a o vaega | ———— | E tusa ai ma le EP(2.1.4&2.9.12) | E tusa ai ma le USP(811) | |
Su'ega | Protease | ≥600U/g | 1.0~5.2Ph.Eur.U/mg | 100~450USP.U/mg |
Amilase | ≥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 | |
Microbial le mama | TAMC | ≤ 10000cfu/g | ≤ 10000cfu/g | ≤ 10000cfu/g |
TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | Fa'atatau | Fa'atatau | Fa'atatau | |
Salmonella | Fa'atatau | Fa'atatau | Fa'atatau |
O a matou fale faʻapipiʻi lelei ma sili lelei lelei faʻatonutonu i laʻasaga uma o le gaosiga e mafai ai ona matou faʻamaonia le faʻamalieina o le au faʻatau mo le faʻaitiitiga tele o Pharmaceutical Raw Materials Powder Pancreatin CAS 8049-47-6, Matou te folafola atu e taumafai i le mea sili e laveaʻiina oe i le tulaga maualuga ma oloa ma auaunaga tau tamaoaiga.
Pa'u teleSaina Pancreatin ma Pancreatin Powder, O loʻo galue la matou kamupani i le faʻatonuga o le "faʻamaoni-faʻavae, galulue faʻatasi, faʻavae tagata, manumalo-manumalo galulue faatasi".Matou te faʻamoemoe e mafai ona matou maua se mafutaga faauo ma tagata fai pisinisi mai le lalolagi atoa.