Pancreatin na Deebio tare da Formulation na Foda, Granule da Pellet

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

Pancreatin na Deebio tare da Formulation na Foda, Granule da Pellet

Lambar CAS:8049-47-6

HS CODE:3507.9090.90

Cikakken Bayani

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Daki-daki

1. Halaye: Pancreatin ɗan launin ruwan kasa ne, amorphous foda ko ɗan ƙaramin launin ruwan kasa zuwa granule mai launin kirim.Ya ƙunshi amylase, lipase da protease.

2. Tushen hakar: Porcine pancreas.

3. tsari: Ana fitar da Pancreatin daga lafiyayyen porcine pancreas ta hanyar fasahar cirewa ta mu ta musamman.

4 .Alamomi da amfani: Pancreatin cakude ne na enzymes masu narkewa da yawa waɗanda ƙwayar porcine ke samarwa.Ana iya amfani dashi a cikin masana'antar harhada magunguna, sarrafa abinci, tanning, wankewa da sauran fannoni, tare da aikace-aikacen da yawa.

Me yasa mu?

· An yi shi a cikin taron GMP

· 27 shekaru na nazarin halittu enzyme R&D tarihi

Ana iya gano albarkatun kasa

· Bi daidaitattun abokin ciniki

· Fitarwa zuwa ƙasashe da yankuna sama da 30

Yana da ikon sarrafa tsarin inganci kamar US FDA, Japan PMDA, Koriya ta Kudu MFDS, da dai sauransu.

Ƙayyadaddun bayanai

Kayan Gwaji		Ƙayyadaddun Kamfanin
Kayan Gwaji		CP	EP	USP
Halaye	Foda	Dan kadan launin ruwan kasa, foda amorphous	Dan kadan launin ruwan kasa, foda amorphous	Dan kadan launin ruwan kasa, foda amorphous
Halaye	Granule	Dan kadan launin ruwan kasa zuwa granule mai launin kirim	Dan kadan launin ruwan kasa zuwa granule mai launin kirim	Dan kadan launin ruwan kasa zuwa granule mai launin kirim
Ganewa		————	Ya dace	————
Gwaji	Abun ciki mai kitse	≤20mg/g	≤ 5.0%	≤3.0% (<3USP);≤ 6.0% (≥3USP)
	Asarar bushewa	≤5.0% 105℃, 4h	≤ 5.0% 670Pa 60℃, 4h	≤ 5.0% Bushewa a cikin Vacuum 60℃, 4h
	Ragowar sauran ƙarfi	————	≤ 0.5% bisa ga EP (5.4)	≤ 0.5% bisa ga USP(467)
	Girman barbashi	————	A cewar EP (2.1.4 & 2.9.12)	A cewar USP (811)
Assay	Kariya	≥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
Najasa Na Ƙanjasa	TAMC	≤ 10000cfu/g	≤ 10000cfu/g	≤ 10000cfu/g
	Farashin TYMC	≤ 100cfu/g	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Ya dace	Ya dace	Ya dace
	Salmonella	Ya dace	Ya dace	Ya dace