China Pancreatin nke Deebio na Formulation nke ntụ ntụ, Granule na Pellet factory na ndị na-emepụta |Deebiotech

Pancreatin nke Deebio nwere nhazi ntụ ntụ, granule na pellet

Nọmba CAS:8049-47-6

Koodu HS:3507.9090.90

Ọrụ faịlụ:Chinese-GMP/EU-GMP/DMF/EU-DMF

Ọkọlọtọ Pharmacopoeia:EP/USP/CP

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Nkọwa ngwaahịa

Mkpado ngwaahịa

Nkọwa

1. Ihe odide: Pancreatin bụ obere aja aja, ntụ ntụ amorphous ma ọ bụ obere aja aja na granule na-acha ude.Ọ mejupụtara amylase, lipase na protease.

2. Isi mmalite: Porcine pancreas.

Usoro 3.: A na-ewepụta Pancreatin na pancreas nke ọma site na teknụzụ mwepu mwepu nke anyị.

4 .Ngosipụta na ojiji: Pancreatin bụ ngwakọta nke ọtụtụ enzymes digestive nke pancreas na-emepụta.Enwere ike iji ya na ụlọ ọrụ ọgwụ, nhazi nri, tanning, ịsacha na mpaghara ndị ọzọ, yana ngwa ngwa dị iche iche.

Gịnị mere anyị?

· Emepụtara na ogbako GMP

· afọ 27 nke akụkọ ihe mere eme nke enzyme R&D

· A na-achọpụta ihe ọkụkụ

· Soro ọkọlọtọ ndị ahịa

· Mbupụ gaa na mba na mpaghara iri atọ

· Nwere ikike nke njikwa sistemụ dị mma dịka US FDA, Japan PMDA, South Korea MFDS, wdg.

Nkọwapụta

Nnwale ihe		Nkọwapụta ụlọ ọrụ
Nnwale ihe		CP	EP	USP
Ndị agwa	Ntụ ntụ	Obere agba aja aja, ntụ ntụ amorphous	Obere agba aja aja, ntụ ntụ amorphous	Obere agba aja aja, ntụ ntụ amorphous
Ndị agwa	Granule	Granule dị ntakịrị aja aja ruo ude	Granule dị ntakịrị aja aja ruo ude	Granule dị ntakịrị aja aja ruo ude
njirimara		————	Dabara	————
Nnwale	Ọdịnaya abụba	≤20mg/g	≤5.0%	≤3.0% (<3USP);≤ 6.0% (≥3USP)
	Ọnwụ na ihicha	≤5.0% 105℃, 4h	≤ 5.0% 670Pa 60℃, 4h	≤ 5.0% Akọrọ na Vacuum 60℃, 4h
	Ihe mgbaze fọdụrụnụ	————	≤ 0.5% Dị ka EP (5.4) si kwuo	≤ 0.5% Dị ka USP (467) si kwuo
	Nha urughuru	————	Dabere na EP (2.1.4 & 2.9.12)	Dabere na USP (811)
Nyocha	Mgbochi	≥600U/g	1.0～5.2 Ph.Eur.U/mg	100～450USP.U/mg
	Amylase	≥7000U/g	12.0～80.0Ph.Eur.U/mg	100～500USP.U/mg
	Lipase	≥4000U/g	15.0～130 Ph.Eur.U/mg	10～90USP.U/mg
Microbial adịghị ọcha	TAMC	≤10000cfu/g	≤10000cfu/g	≤10000cfu/g
	TYMC	≤100cfu/g	≤100cfu/g	≤100cfu/g
	E.coli	Dabara	Dabara	Dabara
	Salmonella	Dabara	Dabara	Dabara