China Pancreatin ea Deebio e entsoeng ka Powder, Granule le Pellet fektheri le bahlahisi |Deebiotech

Pancreatin ea Deebio e nang le Sebopeho sa Powder, Granule le Pellet Featured Image

Pancreatin ea Deebio e nang le Powder, Granule le Pellet

Nomoro ea CAS:8049-47-6

HS CODE:3507.9090.90

Tšebeletso ea Faele:Sechaena-GMP/EU-GMP/DMF/EU-DMF

Pharmacopoeia standard:EP/USP/CP

Re romelle lengolo-tsoibila mahala sampole

Lintlha tsa Sehlahisoa

Li-tag tsa Sehlahisoa

Lintlha

1. Litlhaku: Pancreatin ke phofshoana e sootho hanyane, ea amorphous kapa e sootho hanyane ho isa ho granule ea 'mala oa tranelate.E entsoe ka amylase, lipase le protease.

2. Mohloli oa Mohloli: Li-pancreas tsa Porcine.

3. Ts'ebetso: Pancreatin e ntšoa ho li-pancreas tse phetseng hantle ka theknoloji ea rona e ikhethileng ea ho ntša.

4 .Lipontšo le tšebeliso: Pancreatin ke motsoako oa li-enzyme tse ngata tsa tšilo tse hlahisoang ke manyeme a porcine.E ka sebelisoa indastering ea meriana, ho lokisa lijo, ho suha matlalo, ho hlatsoa le masimo a mang, ka mefuta e mengata ea lits'ebetso.

Hobaneng rona?

·E hlahisoa ka har'a workshop ea GMP

· Lilemo tse 27 tsa nalane ea enzyme ea bioloji ea R&D

· Lisebelisuoa tse tala lia lateloa

·Latela maemo a bareki

· Romella kantle ho naha le libakeng tse fetang 30

·E na le bokhoni ba tsamaiso ea boleng bo kang US FDA, Japan PMDA, South Korea MFDS, joalo-joalo.

Tlhaloso

Lintho tsa Tlhahlobo		Tlhaloso ea Khampani
Lintho tsa Tlhahlobo		CP	EP	USP
Litlhaku	Phofo	Phofo e sootho hanyane, ea amorphous	Phofo e sootho hanyane, ea amorphous	Phofo e sootho hanyane, ea amorphous
Litlhaku	Granule	Granule e sootho hanyane ho isa ho tranelate	Granule e sootho hanyane ho isa ho tranelate	Granule e sootho hanyane ho isa ho tranelate
Boitsebiso		————	E lumellana	————
Liteko	Mafura a mafura	≤20mg/g	≤ 5.0%	≤3.0%(<3USP);≤ 6.0%(≥3USP)
	Tahlehelo ka ho omisa	≤5.0% 105℃, 4h	≤ 5.0% 670Pa 60℃, 4h	≤ 5.0%Dry in Vacuum 60℃, 4h
	Mokelikeli o setseng	————	≤ 0.5% Ho latela EP(5.4)	≤ 0.5% Ho latela USP(467)
	Boholo ba likaroloana	————	Ho latela EP(2.1.4&2.9.12)	Ho latela USP(811)
Tlhahlobo	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
Litšila tsa Microbial	TAMC	≤ 10000cfu/g	≤ 10000cfu/g	≤ 10000cfu/g
	TYMC	≤ 100cfu/g	≤ 100cfu/g	≤ 100cfu/g
	E.coli	E lumellana	E lumellana	E lumellana
	Salmonella	E lumellana	E lumellana	E lumellana