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Safety Information

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

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Synonym(s):
Pancreatin
CAS Number:
MDL number:
UNSPSC Code:
12352204
EC Index Number:
232-468-9

Agency

Ph. Eur.
USP

Quality Level

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

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

Signal Word

Danger

Hazard Statements

Hazard Classifications

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

Target Organs

Respiratory system

WGK

WGK 1

Regulatory Information

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