Pancreatin ya Deebio hamwe no gukora ifu, Granule na Pellet

Pancreatin of Deebio with Formulation of Powder, Granule and Pellet Featured Image

Pancreatin ya Deebio hamwe no gukora ifu, Granule na Pellet

Umubare CAS:8049-47-6

Kode ya HS:3507.9090.90

Ibisobanuro birambuye

Ibiranga ibicuruzwa

Ibisobanuro

1. Inyuguti: Pancreatin ni ifu yijimye gato, ifu ya amorphous cyangwa ibara ryijimye kugeza kuri granule y'amabara.Igizwe na amylase, lipase na protease.

2. Inkomoko yo gukuramo: Porcine pancreas.

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

4 .Ibyerekana no gukoresha: Pancreatin ni uruvange rwimisemburo myinshi igogorwa na pancreas ya pcine.Irashobora gukoreshwa muruganda rwa farumasi, gutunganya ibiryo, gutunganya, gukaraba no mubindi bice, hamwe nibikorwa byinshi.

Kuki twe？

· Yakozwe mu mahugurwa ya GMP

· Imyaka 27 ya enzyme ya biologiya R&D amateka

· Ibikoresho bibisi birashobora gukurikiranwa

· Kurikiza ibipimo byabakiriya

· Kohereza mu bihugu 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	Icyatsi kibisi kugeza kuri cream-granule	Icyatsi kibisi kugeza kuri cream-granule	Icyatsi kibisi kugeza kuri cream-granule
Kumenyekanisha		————	Guhindura	————
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
	Igisigara gisigaye	————	≤ 0.5% Ukurikije EP (5.4)	≤ 0.5% Ukurikije USP (467)
	Ingano ya Particle	————	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
	Umunwa	0004000U / g	15.0～130Ph.Eur.U / mg	10～90USP.U / mg
Microbial Impurities	TAMC	00 10000cfu / g	00 10000cfu / g	00 10000cfu / g
	TYMC	C 100cfu / g	C 100cfu / g	C 100cfu / g
	E.coli	Guhindura	Guhindura	Guhindura
	Salmonella	Guhindura	Guhindura	Guhindura