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104078 Gelatin

Overview

Replacement Information

Key Spec Table

CAS #EC NumberGrade Value
9000-70-8232-554-6Ph Eur,BP,NF

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1.04078.1000
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      Plastic bottle 1 kg
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      Description
      Catalogue Number104078
      References
      Product Information
      CAS number9000-70-8
      EC number232-554-6
      GradePh Eur,BP,NF
      HS Code3503 00 19
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      pH value3.8 - 7.6 (10 g/l, H₂O, 25 °C)
      Dimensions
      Materials Information
      Toxicological Information
      LD 50 oralLD50 Rat > 5000 mg/kg
      Safety Information according to GHS
      Storage class10 - 13 Other liquids and solids
      WGKNWG not water endangering
      Disposal3
      Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C.
      Safety Information
      Product Usage Statements
      Storage and Shipping Information
      StorageStore at +15°C to +25°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
      Appearancefaintly yellow to light yellowish-brown granular powder
      Identity (IR-spectrum)passes test
      Identity (coloring)passes test
      Identity (gelatinizing property)passes test
      pH (10 g/l, CO₂-free water)3.8 - 7.6
      Conductivity (1.0 %, 30 °C)≤ 1 mS/cm
      Sulfur dioxide (SO₂)≤ 50 ppm
      Al (Aluminium)≤ 5 ppm
      Cr (Chromium)≤ 10 ppm
      Fe (Iron)≤ 30 ppm
      Zn (Zinc)≤ 30 ppm
      Peroxide (as H₂O₂)≤ 10 ppm
      Residual solvents (ICH (Q3C))excluded by manufacturing process
      Bloom value (about 110)90 - 130
      Loss on drying (105 °C, 16h)≤ 15.0 %
      Total aerobic microbial count (TAMC)≤ 10³
      Total combined yeasts/moulds count (TYMC)≤ 10²
      Bile-tolerant gram-negative bacteria (absent in 1 g)passes test
      Candida albicans (absent in 1 g)passes test
      Escherichia coli (absent in 1 g)passes test
      Pseudomonas aeruginosa (absent in 1 g)passes test
      Salmonella (absent in 10 g)passes test
      Staphylococcus aureus (absent in 1 g)passes test
      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 the Ph. Eur., BP and NF. The sulfite contentconforms to the requirements according to European directive 95/2/EC.

      Corresponds to the Ph. Eur., BP and NF. The sulfite contentconforms to the requirements according to European directive 95/2/EC.
      Global Trade Item Number
      Catalogue Number GTIN
      1.04078.1000 04022536047218

      Documentation

      Material Qualification Dossier

      TitleVersion
      7.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Gelatin SDS

      Title

      Safety Data Sheet (SDS) 

      Gelatin Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1.04078.1000 Plastic bottlePDF Specification Document

      Certificates

      Title