1.07133

Pancreatin

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

• Synonym(s): Pancreatin
• CAS Number: 8049-47-6
• MDL number: MFCD00131789
• EC Index Number: 232-468-9

Properties

• Quality Level: 500
• Agency: Ph. Eur.; USP
• 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

Description

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

Safety Information

• Pictograms: GHS07,GHS08
• Signal Word: Danger
• Hazard Statements: H315 - H317 - H319 - H334 - H335
• Precautionary Statements: P261 - P264 - P271 - P280 - P302 + P352 - P305 + P351 + P338
• Hazard Classifications: Eye Irrit. 2 - Resp. Sens. 1 - Skin Irrit. 2 - Skin Sens. 1 - STOT SE 3
• Target Organs: Respiratory system
• Storage Class Code: 11 - Combustible Solids
• WGK: WGK 1