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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

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      CO1E1071335000
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          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
          CO1E1071335000 0

          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
          CO1E1071335000 PDF 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