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107130 Pancreatina

(din pancreas porcin) - contine 350 FIP-U/g proteaza , 6000 FIP-U/g lipaza, 7500 FIP-U/g amilaza, EMPROVE® ESSENTIAL USP

Pancreatina MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.
Grade: USP
107130
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Overview

Replacement Information

Key Spec Table

Grade Value
USP

Pricing & Availability

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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: 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/ fumul/ gazul/ ceaţa/ vaporii/ spray-ul.
      P264: Spălaţi-vă pielea bine după utilizare.
      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.
      P304 + P340 + P312: ÎN CAZ DE INHALARE: transportați persoana la aer liber și mențineți-o într-o poziție confortabilă pentru respirație. Sunați la un CENTRU DE INFORMARE TOXICOLOGICĂ/un medic dacă nu vă simțiți bine.
      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 2 substanţe cu potenţial specific de poluare a apei
      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
      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

      Documentation

      Emprove Dossier

      TitleVersion
      4.0

      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
      1071301000 Plastic bottlePDF Specification Document

      Certificates

      Title