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108195 Lactose monohydrate

(milk sugar) special grade for tabletting EMPROVE® ESSENTIAL Ph Eur,BP,ChP,JP,NF

Lactose monohydrate MSDS (material safety data sheet) or SDS, CoA and CoQ, dossiers, brochures and other available documents.

Synonyms: Milk sugar, Lactobiose

CAS #: 10039-26-6 EC Number: 200-559-2 Molar Mass: 360.32 g/mol Hill Formula: C₁₂H₂₂O₁₁ * H₂O Grade: Ph Eur,BP,ChP,JP,NF
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      Key Spec Table

      CAS #EC NumberHill FormulaMolar MassGrade Value
      10039-26-6200-559-2C₁₂H₂₂O₁₁ * H₂O360.32 g/molPh Eur,BP,ChP,JP,NF
      Description
      Catalogue Number108195
      SynonymsMilk sugar, Lactobiose
      References
      Product Information
      CAS number10039-26-6
      EC number200-559-2
      GradePh Eur,BP,ChP,JP,NF
      Hill FormulaC₁₂H₂₂O₁₁ * H₂O
      Molar Mass360.32 g/mol
      HS Code1702 11 00
      Structure formula ImageStructure formula Image
      Quality SegmentMQ500
      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
      WGKWGK 2 obviously hazardous to water
      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
      Assay (HPLC) (calc. on anhydrous substance)98.0 - 102.0 %
      Identity (IR)passes test
      Identity (TLC)passes test
      Identity (HPLC)passes test
      Identity (water)passes test
      Appearance of solution (10 %; water)passes test
      Clarity and color of solutionpasses test
      Acidity or alkalinitypasses test
      Spec. rotation (α 20/D; 10 %; water; calc. on anhydrous substance)+54.4 - +55.9 °
      Heavy metals (as Pb)≤ 5 ppm
      As (Arsenic)≤ 0.0002 %
      Related substances (sum of all impurities) (HPLC)≤ 0.5 %
      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)passes test
      Escherichia coli (absent in 1 g)passes test
      Pseudomonas aeruginosa (absent in 1 g)passes test
      Staphylococcus aureus (absent in 1 g)passes test
      Candida albicans (absent in 1 g)passes test
      Salmonella ssp (absent in 10 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 Ph Eur, BP, ChP, JP, NF
      Corresponds to Ph Eur, BP, ChP, JP, NF
      Global Trade ITEM Number
      Catalogue Number GTIN
      108195 0

      Documentation

      Material Qualification Dossier

      TitleVersion
      10.1

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Required Licenses

      Title
      PRODUCTO REGULADO POR LA SECRETARÍA DE SALUD

      Lactose monohydrate SDS

      Title

      Safety Data Sheet (SDS) 

      Lactose monohydrate Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      108195 PDF Specification Document

      Certificates

      Title