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107133 Pancreatin

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

Pancreatin MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
CAS #: 8049-47-6 EC Number: 232-468-9 Grade: Ph Eur,4 x USP
107133
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Overview

Replacement Information

Key Spec Table

CAS #EC NumberGrade Value
8049-47-6232-468-9Ph Eur,4 x USP

Products

Catalogue NumberPackaging Qty/Pack
1071335000 Fibre carton 5 kg
Description
Catalogue Number107133
References
Product Information
CAS number8049-47-6
EC number232-468-9
GradePh Eur,4 x USP
HS Code3507 90 19
Quality LevelMQ500
Applications
Biological Information
Physicochemical Information
Ignition temperature>360 °C
pH value5 - 6 (10 g/l, H₂O, 20 °C)
Bulk density400 kg/m3
Dimensions
Materials Information
Toxicological Information
LD 50 oralLD50 Rat > 10000 mg/kg
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.
P264: Wash skin thoroughly after handling.
P271: Use only outdoors or in a well-ventilated area.
P280: Wear protective gloves/ eye protection/ face protection.
P302 + P352: IF ON SKIN: Wash with plenty of water.
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 1 slightly hazardous to water
Disposal3
Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
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
Identitypasses test
Activity/FIP (Protease)min. 1400 (activated)
Activity/Ph Eur (Protease)min. 1.4 (activated)
Activity/USP (Protease)min. 100 (not activated)
Activity/FIP (Amylase)≥ 30000 FIP-U/g
Activity/Ph Eur (Amylase)≥ 30 PhEur-U/mg
Activity/USP (Amylase)≥ 100 USP-U/mg
Activity/FIP (Lipase)≥ 24000 FIP-U/g
Activity/Ph Eur (Lipase)≥ 24 PhEur-U/mg
Activity/USP (Lipase)≥ 24 USP-U/mg
AppearanceSlightly brown, fine powder
Al (Aluminium)≤ 50 ppm
Cd (Cadmium)*≤ 0.2 ppm
Fats≤ 3.0 %
Loss on drying (60 °C; 4 h; vacuum < 670 Pa)≤ 5.0 %
Microbiological test≤ 10000 CFU/g; EP/USP indicator microorganisms absent
Acetone (GC)≤ 0.5 %
Residual solvents (Ph Eur/USP/ICH) class 3≤ 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 Ph Eur and 4 x USP
Global Trade Item Number
Catalogue Number GTIN
1071335000 04022536086903

Documentation

Material Qualification Dossier

TitleVersion
7.0

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
1071335000 Fibre cartonPDF Specification Document

Certificates

Title

Technical Info

Title
Vitamin B12 (Lactobacillus) Assay Broth, Base, 111988
Vitamin Biotin Assay Broth, 111989
Vitamin Folic Acid Assay Broth, Base, 111990
Vitamin Pantothenic Acid Assay Broth, Base, 111993