Ubushinwa Pancreatin ya Deebio hamwe no gukora ifu, Granule na Pellet uruganda nababikora |Deebiotech

Pancreatin ya Deebio hamwe no gukora ifu, Granule na Pellet

Umubare CAS:8049-47-6

Kode ya HS:3507.9090.90

Serivisi ya dosiye:Igishinwa-GMP / EU-GMP / DMF / EU-DMF

Ibipimo bya Pharmacopoeia:EP / USP / CP

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Ibicuruzwa birambuye

Ibicuruzwa

Ibisobanuro

1. Inyuguti: Pancreatine ni umutuku wijimye, ifu ya amorphous cyangwa igikara gito kugeza kuri granule y'amabara.Igizwe na amylase, lipase na protease.

2. Inkomoko yo gukuramo: pancreas pancreas.

3. inzira: Pancreatine ikurwa muri pancreas nzima hamwe na tekinoroji yihariye yo gukuramo-gukuramo.

4 .Ibyerekana no gukoresha: Pancreatin ni uruvange rw'imisemburo myinshi igogorwa na pancreas ya pcine.Irashobora gukoreshwa mu nganda zimiti, gutunganya ibiryo, gutunganya, gukaraba no mubindi bice, hamwe nibikorwa byinshi.

Kuki？

· Yakozwe mu mahugurwa ya GMP

· Imyaka 27 ya enzyme ya biologiya R&D amateka

· Ibikoresho bibisi birashobora gukurikiranwa

· Kurikiza amahame y'abakiriya

· Kohereza mu bihugu n'uturere birenga 30

· Ifite ubushobozi bwo gucunga neza sisitemu nka US FDA, Ubuyapani PMDA, Koreya yepfo MFDS, nibindi.

Ibisobanuro

Ibizamini		Ibisobanuro bya sosiyete
Ibizamini		CP	EP	USP
Inyuguti	Ifu	Ifu yijimye gato, ifu ya amorphous	Ifu yijimye gato, ifu ya amorphous	Ifu yijimye gato, ifu ya amorphous
Inyuguti	Granule	Ibara ryijimye gato kuri cream-amabara ya granule	Ibara ryijimye gato kuri cream-amabara ya granule	Ibara ryijimye gato kuri cream-amabara ya granule
Kumenyekanisha		————	Guhuza	————
Ibizamini	Ibinure	≤20mg / g	≤ 5.0%	≤3.0% (<3USP)；≤ 6.0% (≥3USP)
	Gutakaza kumisha	≤5.0% 105 ℃, 4h	≤ 5.0% 670Pa 60 ℃, 4h	≤ 5.0% Kuma muri Vacuum 60 ℃, 4h
	Ibisigisigi	————	≤ 0.5% Ukurikije EP (5.4)	≤ 0.5% Ukurikije USP (467)
	Ingano y'ibice	————	Ukurikije EP (2.1.4 & 2.9.12)	Ukurikije USP (811)
Suzuma	Kurinda	00600U / g	1.0～5.2Ph.Eur.U / mg	100～450USP.U / mg
	Amylase	0007000U / g	12.0～80.0Ph.Eur.U / mg	100～500USP.U / mg
	Lipase	0004000U / g	15.0～130Ph.Eur.U / mg	10～90USP.U / mg
Microbial Impurities	TAMC	≤ 10000cfu / g	≤ 10000cfu / g	≤ 10000cfu / g
	TYMC	C 100cfu / g	C 100cfu / g	C 100cfu / g
	E.coli	Guhuza	Guhuza	Guhuza
	Salmonella	Guhuza	Guhuza	Guhuza