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1.07133

SAFC

Pancreatin

1400 FIP-U/g Protease, 24000 FIP-U/g Lipase, 30000 FIP-U/g Amylase EMPROVE® ESSENTIAL Ph Eur,4 x USP

Pharma Manufacturing

Synonym(s):

Pancreatin

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About This Item

CAS Number:
8049-47-6
MDL number:
MFCD00131789
UNSPSC Code:
12352204
EC Index Number:
232-468-9

agency

Ph. Eur.
USP

Quality Level

500

product line

EMPROVE® ESSENTIAL

form

solid

autoignition temp.

>360 °C

potency

>10000 mg/kg LD50, oral (Rat)

pH

5-6 (20 °C, 10 g/L in H2O)

bulk density

400 kg/m3

application(s)

pharmaceutical
solid formulation

storage temp.

2-8°C

Related Categories

General description

We offer a range of high quality critical raw materials, solvents and reagents plus the documentation and expertise to meet stringent regulatory requirements. In addition to our comprehensive portfolio, we also offer custom manufacturing services to meet your exact needs. As part of our Emprove® Program, our raw materials are offered with extensive documentation facilitating compliance of your pharma and biopharma product, full supply chain transparency and risk mitigation. Our SAFC® portfolio of high-quality products for biopharmaceutical and pharmaceutical formulation and production withstands strict quality control procedures and is produced according to applicable cGMP guidelines.

Application

Pancreatin is a digestive enzyme used to supplement the body′s natural supply of such enzymes. Pancreatin Emprove® Essential is suitable for pharmaceutical applications.

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany
SAFC is a registered trademark of Merck KGaA, Darmstadt, Germany

pictograms

Health hazardExclamation mark
GHS08,GHS07

signalword

Danger

Hazard Classifications

Eye Irrit. 2 - Resp. Sens. 1 - Skin Irrit. 2 - Skin Sens. 1 - STOT SE 3

target_organs

Respiratory system

Storage Class

11 - Combustible Solids

wgk_germany

WGK 1

What is the Emprove® Program?

The Emprove® Program is a system providing comprehensive and thorough documentation of our filters and single-use components, pharma raw materials, and starting materials. Four document types are included with an Emprove® Program subscription:

Material Qualification Dossier

Free of charge - Sign in to download

Quality Management Dossier

Available by subscription or for a fee

Operational Excellence Dossier

Available by subscription or for a fee

Learn more about the benefits an Emprove® Program subscription can provide
Why are these documents unavailable?
Emprove® Dossiers contain information intended to support the registration process and risk assessment activities of pharmaceutical producers and contain confidential information. Please contact us if you would like access.

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