China Pancreatin of Deebio with Formulation of Powder, Granule and Pellet factory and manufacturers

Pancreatin of Deebio with Formulation of Powder, Granule and Pellet

CAS Number: 8049-47-6

HS CODE: 3507.9090.90

File Service: Chinese-GMP/EU-GMP/DMF/EU-DMF

Pharmacopoeia standard: EP/USP/CP

Send email to us free sample

Product Detail

Product Tags

Detail

1. Characters: Pancreatin is a slightly brown, amorphous powder or slightly brown to cream-coloured granule. It is composed of amylase, lipase and protease.

2. Extraction Source: Porcine pancreas.

3. process: Pancreatin is extracted from healthy porcine pancreas by our exclusive activation-extraction technology.

4 .Indications and uses: Pancreatin is a mixture of several digestive enzymes produced by the pancreas of porcine. It can be used in the pharmaceutical industry, food processing, tanning, washing and other fields, with a wide range of applications.

Why us？

·Produced in GMP workshop

·27 years of biological enzyme R&D history

·Raw materials are traceable

·Comply with customer standard

·Export to over 30 countries and regions

·Has the ability of quality system management such as US FDA, Japan PMDA, South Korea MFDS, etc.

Specification

Test Items		Company Specification
Test Items		CP	EP	USP
Characters	Powder	A slightly brown, amorphous powder	A slightly brown, amorphous powder	A slightly brown, amorphous powder
Characters	Granule	A slightly brown to cream-coloured granule	A slightly brown to cream-coloured granule	A slightly brown to cream-coloured granule
Identification		————	Conforms	————
Tests	Fat content	≤20mg/g	≤ 5.0%	≤3.0%(<3USP)；≤ 6.0%(≥3USP)
	Loss on drying	≤5.0% 105℃, 4h	≤ 5.0% 670Pa 60℃, 4h	≤ 5.0%Dry in Vacuum 60℃, 4h
	Residual solvent	————	≤ 0.5%According to EP(5.4)	≤ 0.5%According to USP(467)
	Particle size	————	According to EP(2.1.4&2.9.12)	According to USP(811)
Assay	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
Microbial Impurities	TAMC	≤ 10000cfu/g	≤ 10000cfu/g	≤ 10000cfu/g
	TYMC	≤ 100cfu/g	≤ 100cfu/g	≤ 100cfu/g
	E.coli	Conforms	Conforms	Conforms
	Salmonella	Conforms	Conforms	Conforms