137045 | Lactose monohydrate

137045
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      Overview

      Replacement Information

      Key Spec Table

      CAS #EC NumberHill FormulaMolar MassGrade Value
      10039-26-6200-559-2C₁₂H₂₂O₁₁ * H₂O360.32 g/molPh Eur,BP,NF,JP

      Pricing & Availability

      Catalogue NumberAvailability Packaging Qty/Pack Price Quantity
      1370455000
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          Plastic bottle 5 kg
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          1370459029
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              Double PE Sack 25 kg
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              Description
              Catalogue Number137045
              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
              Applications
              ApplicationLactose monohydrate powder suitable for the biopharmaceutical production EMPROVE® bio Ph Eur,BP,NF,JP. CAS 10039-26-6, pH 4.0 - 6.5 (100 g/l, H₂O, 20 °C).
              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
              Identitypasses 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 (Ph.Eur./USP/ICH)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 %
              Endotoxins< 50|I.U./g
              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
              Corresponds to Ph Eur,BP,NF,JP

              Documentation

              Material Qualification Dossier

              Title

              Quality Management Dossier

              Title

              Operational Excellence Dossier

              Title

              SDS

              Title

              Safety Data Sheet (SDS) 

              Certificates of Analysis

              Product Number PackagingSpecificationLot Number
              1370455000 Plastic bottlePDF Specification Document
              1370459029 Double PE SackPDF Specification Document

              Certificates

              Title

              Reach Use

              Title
              Reach Use