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107130 Pancreatin

Overview

Replacement Information

Key Spec Table

Grade Value
USP

Pricing & Availability

Catalogue Number AvailabilityPackaging Qty/Pack Price Quantity
1071301000
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      Plastic bottle 1 kg
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      CO1E1071301000
      Retrieving availability...
      Limited Availability
Limited Availability
      In Stock 
      Discontinued
      Limited Quantities Available
      Availability to be confirmed
        Remaining : Will advise
          Remaining : Will advise
          Will advise
          Contact Customer Service
          Contact Customer Service

          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
          Catalogue Number GTIN
          1071301000 04022536086873
          CO1E1071301000 0

          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
          CO1E1071301000 PDF Specification Document

          Certificates

          Title