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107130 Pankreatin

Overview

Replacement Information

Key Spec Table

Grade Value
USP

Pricing & Availability

Catalogue Number AvailabilityPackaging Qty/Pack Price Quantity
1071301000
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      Botol plastik 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: Menyebabkan iritasi kulit.
      H317: Dapat menyebabkan reaksi alergi pada kulit.
      H319: Menyebabkan iritasi mata yang serius.
      H334: Dapat menyebabkan alergi atau gejala asma atau kesulitan bernafas jka terhrup.
      H335: Dapat menyebabkan iritasi pada saluran pernafasan.
      Precautionary Statement(s)P261: Hindari menghirup debu/asap/gas/kabut/uap/semburan.
      P264: Cuci kulit dengan seksama setelah menangani.
      P280: Kenakan sarung tangan/ pelindung mata/ pelindung wajah.
      P302 + P352: JIKA TERKENA KULIT: Cucilah dengan air yang banyak.
      P304 + P340 + P312: JIKA TERHIRUP: Pindahkan korban ke udara segar dan posisikan yang nyaman untuk bernapas. Hubungi SENTRA INFORMASI KERACUNAN atau dokter/enaga medis jika kamu merasa tidak sehat.
      P305 + P351 + P338: JIKA TERKENA MATA : Bilas dengan seksama dengan air untuk beberapa menit. Lepaskan lensa kontak jika memakainya dan mudah melakukannya.Lanjutkan membilas.
      Signal WordBahaya
      Storage class10 - 13 Cairan dan padatan lain
      WGKWGK 2 membahayakan air secara signifikan
      Safety Information
      Categories of dangermengiritasi, dapat meningkatkan kepekaan
      Product Usage Statements
      Storage and Shipping Information
      StorageSimpan pada +2°C hingga +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

      Material Qualification Dossier

      TitleVersion
      4.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Pankreatin MSDS

      Title

      Safety Data Sheet (SDS) 

      Pankreatin Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1071301000 Botol plastikPDF Specification Document

      Certificates

      Title