Pancreatin of with Formulation of Powder, Granule and Pellet

Introduction

CAS Number: 8049-47-6 HS CODE: 3507.9090.90 File Service: Chinese-GMP/EU-GMP/DMF/EU-DMF Pharmacopoeia standard: EP/USP/CP

Product Details

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

CP

EP

USP

Characters

Powder

A slightly brown, amorphous powder

A slightly brown, amorphous powder

A slightly brown, amorphous powder

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

1.05.2Ph.Eur.U/mg

100450USP.U/mg

Amylase

≥7000U/g

12.080.0Ph.Eur.U/mg

100500USP.U/mg

Lipase

≥4000U/g

15.0130Ph.Eur.U/mg

1090USP.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


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