I-Pancreatin ye-Deebio kunye noKuqulunqwa kwePowder, iGranule kunye nePellet

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

I-Pancreatin ye-Deebio kunye noKuqulunqwa kwePowder, iGranule kunye nePellet

Inombolo yeCAS:8049-47-6

IKHOWUDI ye-HS:3507.9090.90

Iinkcukacha zeMveliso

Iithegi zeMveliso

Iinkcukacha

1. Abalinganiswa: I-Pancreatin ngumgubo omdaka kancinane, o-amorphous okanye umdaka kancinci ukuya kwigranule enombala okhrimu.Iqulethwe yi-amylase, i-lipase kunye ne-protease.

2. Ukukhutshwa Umthombo: Ipancreas yehagu.

3. Inkqubo: I-Pancreatin itsalwa kwi-pancreas enempilo ye-porcine ngeteknoloji yethu yokukhupha iteknoloji ekhethekileyo.

4 .Izibonakaliso kunye nokusetyenziswa: I-Pancreatin ngumxube wee-enzyme ezininzi zokugaya eziveliswa yi-pancreas ye-porcine.Ingasetyenziswa kwishishini lamayeza, ukusetyenzwa kokutya, ukuthambisa, ukuhlamba kunye nezinye iindawo, ezinoluhlu olubanzi lwezicelo.

Kutheni sisi?

·Iveliswe kwiworkshop yeGMP

· Iminyaka engama-27 yembali ye-enzyme yebhayoloji ye-R&D

·Imathiriyeli ekrwada iyalandeleka

·Thobela umgangatho wabathengi

·Thumela ngaphandle kumazwe angaphezu kwama-30 kunye nemimandla

·Unamandla olawulo lwenkqubo esemgangathweni efana ne-US FDA, Japan PMDA, South Korea MFDS, njl.

Inkcazo

Izinto zovavanyo		Inkcazo yeNkampani
Izinto zovavanyo		CP	EP	USP
Abalinganiswa	Umgubo	Umgubo kancinane omdaka, oneamorphous	Umgubo kancinane omdaka, oneamorphous	Umgubo kancinane omdaka, oneamorphous
Abalinganiswa	Igranule	Igranule emdaka kancinci ukuya kombala okhrimu	Igranule emdaka kancinci ukuya kombala okhrimu	Igranule emdaka kancinci ukuya kombala okhrimu
Ukuchongwa		————	Iyahambelana	————
Iimvavanyo	Umxholo wamafutha	≤20mg/g	≤ 5.0%	≤3.0%(<3USP);≤ 6.0%(≥3USP)
	Ilahleko ekomisweni	≤5.0% 105℃, 4h	≤ 5.0% 670Pa 60℃, 4h	≤ 5.0% Yomile kwiVacuum 60℃, 4h
	Isinyibilikisi esishiyekileyo	————	≤ 0.5% Ngokungqinelana ne-EP(5.4)	≤ 0.5%Ngokungqinelana ne-USP(467)
	Ubungakanani besuntswana	————	Ngokwe-EP(2.1.4&2.9.12)	Ngokutsho kwe-USP(811)
Isivavanyi	Iprotease	≥600U/g	1.0～5.2Ph.Eur.U/mg	I-100～450USP.U/mg
	Amylase	≥7000U/g	12.0～80.0Ph.Eur.U/mg	I-100～500USP.U/mg
	Lipase	≥4000U/g	15.0～130Ph.Eur.U/mg	10～90USP.U/mg
Ukungcola kweMicrobial	TAMC	≤ 10000cfu/g	≤ 10000cfu/g	≤ 10000cfu/g
	I-TYMC	≤ 100cfu/g	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Iyahambelana	Iyahambelana	Iyahambelana
	Salmonella	Iyahambelana	Iyahambelana	Iyahambelana