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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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Key Specifications Table

Grade Value
USP

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1071301000
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      		 Plastic bottle 1 kg
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      Description
      Catalogue Number107130
      References
      Product Information
      GradeUSP
      HS Code3507 90 19
      Quality LevelMQ500
      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
      Catalog Number GTIN
      1071301000 04022536086873

      Documentation

      Material Qualification Dossier

      TitleVersion
      4.0

      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
      1071301000 Plastic bottlePDF Specification Document

      Certificates

      Title