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1. Makhalidwe: Pancreatin ndi ufa wofiirira pang'ono, wonyezimira pang'ono kapena wofiirira pang'ono mpaka granule wamtundu wa kirimu.Zimapangidwa ndi amylase, lipase ndi protease.
2. Kuchotsa Gwero: Nkhumba za nkhumba.
3. Njira: Pancreatin imachotsedwa ku nkhumba yathanzi ya nkhumba ndiukadaulo wathu wokhawokha wotulutsa.
4 .Zizindikiro ndi ntchito: Pancreatin ndi chisakanizo cha michere yambiri ya m'mimba yopangidwa ndi kapamba wa nkhumba.Itha kugwiritsidwa ntchito m'makampani opanga mankhwala, kukonza chakudya, kuwotcha, kutsuka ndi zina, ndikugwiritsa ntchito zosiyanasiyana.
· Zapangidwa mu GMP workshop
· Zaka 27 za mbiri ya biological enzyme R&D
·Zida zopangira ndi zopezeka
· Tsatirani muyezo wamakasitomala
· Tumizani kumayiko ndi zigawo zopitilira 30
·Ali ndi luso loyang'anira machitidwe abwino monga US FDA, Japan PMDA, South Korea MFDS, etc.
Zinthu Zoyesa | Mafotokozedwe a Kampani | |||
CP | EP | USP | ||
Makhalidwe | Ufa | Ufa wofiirira pang'ono, wa amorphous | Ufa wofiirira pang'ono, wa amorphous | Ufa wofiirira pang'ono, wa amorphous |
Granule | Granule yofiirira pang'ono mpaka yamtundu wa kirimu | Granule yofiirira pang'ono mpaka yamtundu wa kirimu | Granule yofiirira pang'ono mpaka yamtundu wa kirimu | |
Chizindikiritso | ———— | Zimagwirizana | ———— | |
Mayesero | Mafuta okhutira | ≤20mg/g | ≤ 5.0% | ≤3.0%(<3USP);≤ 6.0%(≥3USP) |
Kutaya pakuyanika | ≤5.0% 105 ℃, 4h | ≤ 5.0% 670Pa 60℃, 4h | ≤ 5.0% Yanikani mu Vacuum 60 ℃, 4h | |
Zosungunulira zotsalira | ———— | ≤ 0.5%Malinga ndi EP(5.4) | ≤ 0.5% molingana ndi USP(467) | |
Tinthu kukula | ———— | Malinga ndi EP(2.1.4&2.9.12) | Malinga ndi USP(811) | |
Kuyesa | 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 | |
Zowonongeka za Microbial | Mtengo wa TAMC | ≤ 10000cfu/g | ≤ 10000cfu/g | ≤ 10000cfu/g |
Mtengo wa TYMC | ≤ 100cfu/g | ≤ 100cfu/g | ≤ 100cfu/g | |
E.coli | Zimagwirizana | Zimagwirizana | Zimagwirizana | |
Salmonella | Zimagwirizana | Zimagwirizana | Zimagwirizana |
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