108195 Lactose monohydrate

108195
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      Overview

      Replacement Information

      Key Specifications Table

      CAS #EC NumberHill FormulaMolar MassGrade Value
      10039-26-6 200-559-2 C₁₂H₂₂O₁₁ * H₂O 360.32 g/mol Ph Eur,BP,NF,JP

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      Catalog Number AvailabilityPackaging Qty/Pack Price Quantity
      1.08195.9029
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          Double PE Sack 25 kg
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          Description
          Catalogue Number108195
          SynonymsMilk sugar, Lactobiose
          References
          Product Information
          CAS number10039-26-6
          EC number200-559-2
          GradePh Eur,BP,NF,JP
          Hill FormulaC₁₂H₂₂O₁₁ * H₂O
          Molar Mass360.32 g/mol
          HS Code1702 11 00
          Structure formula ImageStructure formula Image
          Applications
          Biological Information
          Physicochemical Information
          Ignition temperature390 °C
          Melting Point202 °C
          pH value4.0 - 6.5 (100 g/l, H₂O, 20 °C)
          Bulk density500 kg/m3
          Solubility161 g/l
          Dimensions
          Materials Information
          Toxicological Information
          LD 50 oralLD50 Rat > 10000 mg/kg
          Safety Information according to GHS
          RTECSOD9625000
          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
          Identity (IR-spectrum)passes test
          Identity (TLC)passes test
          Identity (water)passes test
          Appearance of solution (10 %; water)passes test
          Acidity or alkalinitypasses test
          Spec. rotation (α 20/D; 10 %; water; calc. on anhydrous substance)+54.4 - +55.9 °
          Heavy metals (as Pb)≤ 0.0005 %
          As (Arsenic)≤ 0.0001 %
          Cu (Copper)≤ 0.0025 %
          Pb (Lead)≤ 0.00005 %
          Zn (Zinc)≤ 0.0025 %
          Residual solvents (ICH Q3C)excluded by the production process
          Proteins and UV-absorbing impuritiespasses test
          Sulfated ash≤ 0.1 %
          Loss on drying (80 °C, 2 h)≤ 0.5 %
          Water4.5 - 5.5 %
          Particle size (< 100 µm)≤ 50 %
          Particle size (> 250 µm)≤ 2 %
          Microbiological purity (Total aerobic microbial count (TAMC))≤ 100 CFU/g
          Microbiological purity (Total yeast and mould count (TYMC))≤ 50 CFU/g
          Bile tolerant Gram negative Bacteria (absent in 1 g)conforms
          Escherichia coli (absent in 1 g)conforms
          Pseudomonas aeruginosa (absent in 1 g)conforms
          Staphylococcus aureus (absent in 1 g)conforms
          Candida albicans (absent in 1 g)conforms
          Salmonella ssp (absent in 10 g)conforms
          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, BP, NF, JP

          Documentation

          Material Qualification Dossier

          Title

          Quality Management Dossier

          Title

          Operational Excellence Dossier

          Title

          Lactose monohydrate SDS

          Title

          Safety Data Sheet (SDS) 

          Lactose monohydrate Certificates of Analysis

          Product Number PackagingSpecificationLot Number
          1.08195.9029 Double PE SackPDF Specification Document

          Certificates

          Title