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107130 Pancreatin

(from porcine pancreas) 350 FIP-U/g Protease, 6000 FIP-U/g Lipase, 7500 FIP-U/g Amylase, EMPROVE® ESSENTIAL USP

Pancreatin MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
Grade: USP
107130
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Overview

Replacement Information

Key Spec Table

Grade Value
USP

Products

Catalogue NumberPackaging Qty/Pack
1.07130.1000 Plastic bottle 1 kg
Description
Catalogue Number107130
References
Product Information
GradeUSP
HS Code3507 90 19
Quality SegmentMQ500
Applications
Biological Information
Physicochemical Information
Dimensions
Materials Information
Toxicological Information
Safety Information according to GHS
Hazard Pictogram(s) Hazard Pictogram(s)
Hazard Pictogram(s)
Hazard Statement(s)H315: Causes skin irritation.
H317: May cause an allergic skin reaction.
H319: Causes serious eye irritation.
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled.
H335: May cause respiratory irritation.
Precautionary Statement(s)P261: Avoid breathing dust/ fume/ gas/ mist/ vapours/ spray.
P264: Wash skin thoroughly after handling.
P280: Wear protective gloves/ eye protection/ face protection.
P302 + P352: IF ON SKIN: Wash with plenty of water.
P304 + P340 + P312: IF INHALED: Remove person to fresh air and keep comfortable for breathing. Call a POISON CENTER/doctor if you feel unwell.
P305 + P351 + P338: IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing.
Signal WordDanger
Storage class10 - 13 Other liquids and solids
WGKWGK 2 obviously hazardous to water
Safety Information
Categories of dangerirritant, sensitizing
Product Usage Statements
Storage and Shipping Information
StorageStore at +2°C to +8°C.
Packaging Information
Transport Information
Declaration (railroad and road) ADR, RIDKein Gefahrgut
Declaration (transport by air) IATA-DGRNo Dangerous Good
Declaration (transport by sea) IMDG-CodeNo Dangerous Good
Supplemental Information
Specifications
Activity/FIP (Protease)min. 350 (activated)
Activity/Ph Eur (Protease)min.0.35 (activated)
Activity/USP (Protease)min. 25 (not activated)
Activity/FIP (Amylase)min 7500
Activity/Ph Eur (Amylase)min 7.5
Activity/USP (Amylase)min 25
Activity/FIP (Lipase)min 6000
Activity/Ph Eur (Lipase)min 6.0
Activity/USP (Lipase)min 6.0
AppearancePale yellow to light brown powder
Al (Aluminium)≤ 50 ppm
Cd (Cadmium)*≤ 0.2 ppm
Fatsmax 3.0
Loss on drying (60 °C; 4 h; vacuum < 670 Pa)max 5.0
Microbiological test≤ 10000 CFU/g; EP/USP indicator microorganisms absent
Acetone (GC)max 0.5
Residual solvents (Ph Eur/USP/ICH) class 3max 0.5
Other residual solvents (Ph Eur/USP/ICH)excluded by production process
Elemental impurity specifications have been set considering ICH Q3D (Guideline for Elemental Impurities). Class 1-3 elements are not
likely to be present above the ICH Q3D option 1 limit, unless specified and indicated (*).
Corresponds to USP
Global Trade ITEM Number
Catalogue Number GTIN
1.07130.1000 04022536086873

Documentation

Material Qualification Dossier

TitleVersion
5.1

Quality Management Dossier (Open Access)

Title

Operational Excellence Dossier

Title

Pancreatin SDS

Title

Safety Data Sheet (SDS) 

Pancreatin Certificates of Analysis

Product Number PackagingSpecificationLot Number
1.07130.1000 Plastic bottlePDF Specification Document

Certificates

Title