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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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      		 Fibre carton 5 kg
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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
      1.07133.5000 04022536086903

      Documentation

      Material Qualification Dossier

      TitleVersion
      8.0

      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
      1.07133.5000 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