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107133 Pankreatin

1400 FIP-U/g Protease, 24000 FIP-U/g Lipase, 30000 FIP-U/g Amilase, EMPROVE® ESSENTIAL Ph Eur,4 x USP

Pankreatin 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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Replacement Information

Key Spec Table

CAS #EC NumberGrade Value
8049-47-6232-468-9Ph Eur,4 x USP

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      		 Karton fiber 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 Tikus > 10000 mg/kg
      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.
      P264: Cuci kulit dengan seksama setelah menangani.
      P271: Gunakan hanya di luar ruangan atau di tempat yang berventilasi baik.
      P280: Kenakan sarung tangan/ pelindung mata/ pelindung wajah.
      P302 + P352: JIKA TERKENA KULIT: Cucilah dengan air yang banyak.
      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 1 agak berbahaya untuk air
      Disposal3
      Reagen organik yang relatif tidak aktif harus dikumpulkan dalam kategori A. Jika terhalogenasi, harus ditempatkan dalam Kategori B. Untuk residu padat gunakan Kategori C.
      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
      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

      Material Qualification Dossier

      TitleVersion
      7.0

      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
      1071335000 Karton fiberPDF Specification Document

      Certificates

      Title

      Technical Info

      Title
      Vitamin Biotin Assay Broth, 111989
      Vitamin Pantothenic Acid Assay Broth, Base, 111993