1. Yam ntxwv: Pancreatin yog xim av me ntsis, amorphous hmoov los yog me ntsis xim av rau cream-xim granule.Nws yog tsim los ntawm amylase, lipase thiab protease.
2. Extraction Source: Porcine pancreas.
3. txheej txheem: Pancreatin yog muab rho tawm los ntawm kev noj qab haus huv porcine pancreas los ntawm peb tshwj xeeb ua kom-extraction technology.
4 .Indications thiab siv: Pancreatin yog ib tug sib tov ntawm ob peb digestive enzymes uas ua los ntawm lub pancreas ntawm porcine.Nws tuaj yeem siv rau hauv kev lag luam tshuaj, kev ua zaub mov, tanning, ntxuav thiab lwm yam, nrog rau ntau yam kev siv.
· Ua nyob rau hauv GMP Rhiav
· 27 xyoo ntawm biological enzyme R & D keeb kwm
· Cov ntaub ntawv nyoos yog traceable
· Ua raws li cov neeg siv khoom tus qauv
· Export rau ntau tshaj 30 lub teb chaws thiab cheeb tsam
· Muaj peev xwm ntawm kev tswj xyuas zoo xws li US FDA, Nyiv PMDA, Kaus Lim Qab Teb MFDS, thiab lwm yam.
Cov khoom kuaj | Tuam txhab Specification | |||
CP | EP | USP | ||
Cov cim | Hmoov | Ib me ntsis xim av, amorphous hmoov | Ib me ntsis xim av, amorphous hmoov | Ib me ntsis xim av, amorphous hmoov |
Granule | Ib me ntsis xim av rau cream-xim granule | Ib me ntsis xim av rau cream-xim granule | Ib me ntsis xim av rau cream-xim granule | |
Kev txheeb xyuas | —————— | Ua raws | —————— | |
Kev sim | Cov ntsiab lus rog | ≤ 20mg / g | ≤ 5.0% | ≤3.0% (<3USP).≤ 6.0% (≥3USP) |
Poob rau ziab | ≤5.0% 105 ℃, 4h | ≤ 5.0% 670Pa 60 ℃, 4h | ≤ 5.0% Qhuav hauv Nqus 60 ℃, 4h | |
Residual kuab tshuaj | —————— | ≤ 0.5% Raws li EP(5.4) | ≤ 0.5% Raws li USP(467) | |
Particle loj | —————— | Raws li EP(2.1.4 & 2.9.12) | Raws li USP (811) | |
Assay | Protease | ≥600U / g | 1.0~5.2 Ph.Eur.U/mg | 100~450 USP.U/mg |
Amylase | ≥7000U / g | 12.0 Nws~80.0 Ph.Eur.U/mg | 100~500 USP.U / mg | |
Lipase | ≥4000U / g | 15.0 Nws~130 Ph.Eur.U/mg | 10~90 USP.U/mg | |
Microbial impurities | TAMC | ≤ 10000cfu / g | ≤ 10000cfu / g | ≤ 10000cfu / g |
TYMC | ≤ 100cfu / g | ≤ 100cfu / g | ≤ 100cfu / g | |
E.coli | Ua raws | Ua raws | Ua raws | |
Salmonella | Ua raws | Ua raws | Ua raws |