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107130 Pancreatin

Overview

Key Spec Table

Grade Value
USP

Pricing & Availability

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1071301000
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      Description
      Catalogue Number107130
      Product Information
      GradeUSP
      HS Code3507 90 90
      Quality LevelMQ500
      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
      Storage and Shipping Information
      StorageStore at +2°C to +8°C.
      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
      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
      Catalogue Number GTIN
      1071301000 04022536086873