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107147 Papain 6000 USP-U/mg

Overview

Replacement Information

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1071475000
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      Plastic bottle 5 kg
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      Description
      Catalogue Number107147
      References
      Product Information
      HS Code3507 90 90
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      pH value4 - 7 (1 g/l, H₂O, 25 °C)
      Bulk density800 kg/m3
      Dimensions
      Materials Information
      Toxicological Information
      Safety Information according to GHS
      Hazard Pictogram(s) Hazard Pictogram(s)
      Hazard Statement(s)H315: Causes skin irritation.
      H319: Causes serious eye irritation.
      H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled.
      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
      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 dangersensitizing
      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 (Casein, pH 6.0, 40 °C)≥ 6000 USP-U/mg
      AppearanceAlmost white, fine powder
      Loss on drying (60 °C; 4 h; vacuum)≤ 7.0 % (w/w)
      pH-value (1 in 50; water)4.8 - 6.2
      Al (Aluminium)≤ 50 ppm
      V (Vanadium)*≤ 1 ppm
      Water (according to Karl Fischer)≤ 6 %
      Microbiological test≤ 500 CFU/g; EP/USP indicator microorganisms absent
      Residual solvents (Ph Eur/USP/ICH)excluded by manufacturing process
      Lot (USP reference standard)
      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

      Documentation

      Material Qualification Dossier

      TitleLot Number
      1.0

      Quality Management Dossier

      Title

      Operational Excellence Dossier

      Title

      Papain 6000 USP-U/mg SDS

      Title

      Safety Data Sheet (SDS) 

      Papain 6000 USP-U/mg Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1071475000 Plastic bottlePDF Specification Document

      Certificates

      Title