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107133 Pancreatina -

contine 1400 FIP-U/g proteaza, 24000 FIP-U/g lipaza, 30000 FIP-U/g amilaza, EMPROVE® ESSENTIAL Ph Eur,4 x USP

Pancreatina - 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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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: Provoacă iritarea pielii.
      H317: Poate provoca o reacţie alergică a pielii.
      H319: Provoacă o iritare gravă a ochilor.
      H334: Poate provoca simptome de alergie sau astm sau dificultăţi de respiraţie în caz de inhalare.
      H335: Poate provoca iritarea căilor respiratorii.
      Precautionary Statement(s)P261: Evitaţi să inspiraţi praful.
      P264: Spălaţi-vă pielea bine după utilizare.
      P271: A se utiliza numai în aer liber sau în spaţii bine ventilate.
      P280: Purtaţi mănuşi de protecţie/ echipament de protecţie a ochilor/ echipament de protecţie a feţei.
      P302 + P352: ÎN CAZ DE CONTACT CU PIELEA: spălați cu multă apă.
      P305 + P351 + P338: ÎN CAZ DE CONTACT CU OCHII: Clătiți cu atenție cu apă timp de mai multe minute. Scoateți lentilele de contact, dacă este cazul și dacă acest lucru se poate face cu ușurință. Continuați să clătiți.
      Signal WordPericol
      Storage class10 - 13 Alte lichide sau solide
      WGKWGK 1 slabă contaminare a apei
      Disposal3
      Reactivii organici relativ cu reactivitate relativ redusa trebuie colectati in containerul A. Daca sunt halogenati, ei trebuie colectati in containerul B. Pentru reziduurile solide utilizati containerul C.
      Safety Information
      Categories of dangeriritant, sensibilizator
      Product Usage Statements
      Storage and Shipping Information
      StorageA se depozita între +2°C la +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
      1071335000 04022536086903

      Documentation

      Emprove Dossier

      TitleVersion
      7.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Pancreatina - MSDS

      Title

      Safety Data Sheet (SDS) 

      Pancreatina - Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1071335000 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