China Pancreatin wa Deebio Wopanga Ufa, Granule ndi Pellet fakitale ndi opanga |Deebiotech

Pancreatin of Deebio yokhala ndi Ufa, Granule ndi Pellet Featured Image

Pancreatin wa Deebio ndi Mapangidwe a ufa, Granule ndi Pellet

Nambala ya CAS:8049-47-6

HS KODI:3507.9090.90

Ntchito Yafayilo:Chinese-GMP/EU-GMP/DMF/EU-DMF

Pharmacopoeia muyezo:EP/USP/CP

Titumizireni imelo chitsanzo chaulere

Tsatanetsatane wa Zamalonda

Zolemba Zamalonda

Tsatanetsatane

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.

Chifukwa chiyani ife?

· 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.

Kufotokozera

Zinthu Zoyesa		Mafotokozedwe a Kampani
Zinthu Zoyesa		CP	EP	USP
Makhalidwe	Ufa	Ufa wofiirira pang'ono, wa amorphous	Ufa wofiirira pang'ono, wa amorphous	Ufa wofiirira pang'ono, wa amorphous
Makhalidwe	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