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102776 Trehalose dihydrate

EMPROVE® EXPERT Ph Eur,ChP,NF,JP

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

Synonyms: 1-O-alpha-D-Glucopyranosyl-alpha-D-glucopyranoside

CAS #: 6138-23-4 EC Number: 202-739-6 Molar Mass: 378.33 g/mol Grade: Ph Eur,ChP,NF,JP
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Key Spec Table

CAS #EC NumberMolar MassGrade Value
6138-23-4202-739-6378.33 g/molPh Eur,ChP,NF,JP

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      Description
      Catalogue Number102776
      Synonyms1-O-alpha-D-Glucopyranosyl-alpha-D-glucopyranoside
      References
      Product Information
      CAS number6138-23-4
      EC number202-739-6
      GradePh Eur,ChP,NF,JP
      Molar Mass378.33 g/mol
      HS Code2940 00 99
      Quality LevelMQ500
      Applications
      Biological Information
      Physicochemical Information
      Melting Point96.5 - 97.5 °C
      Dimensions
      Materials Information
      Toxicological Information
      Safety Information according to GHS
      Storage class10 - 13 Other liquids and solids
      WGKWGK 1 slightly 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
      StorageNoTempLimit
      Packaging Information
      Transport Information
      Supplemental Information
      Specifications
      Descriptionwhite to almost white, crystalline powder
      Assay (HPLC, calc. on anhydrous substance)98.0 - 101.0 %
      Identity (IR)conforms
      Identity (retention time, ChP)conforms
      Appearance of solution (10 %, water)passes test
      Color and clarity of solution, Absorbance (720nm; 33%; 10cm; water)≤ 0.033
      Color and clarity of solution, Absorbance (420 - 720nm; 33%; 10cm; water)≤ 0.067
      pH-value (10 %; water)4.5 - 6.5
      Spec. rotation (α 20/D; 10 %; water; calc. on anhydrous substance)+197 - +201 °
      Chloride (Cl)≤ 125 ppm
      Sulfate (SO₄)≤ 200 ppm
      Nitrogen (N)≤ 0.005 %
      Heavy metals (as Pb)≤ 5 ppm
      Related substances (HPLC) (Glucose (impurity A))≤ 0.5
      Related substances (HPLC) (Maltotriose (impurity B))≤ 0.2
      Related substances (HPLC) (unspecified impurities single)≤ 0.2
      Related substances (HPLC) (Sum of all impurities)≤ 0.5
      Residual solvents (ICHQ3C) of class 2 (Methanol)≤ 300
      Other residual solvents (ICH Q3C)excluded by manufacturing process
      Soluble starch (Ph Eur, ChP, NF)passes test
      Dextrin, soluble starch and sulfite (JP)passes test
      Residue on ignition≤ 0.1
      Water (according to Karl Fischer)9.0 - 11.0 %
      Endotoxins< 0.3
      Total aerobic microbial count≤ 100
      Total yeast and mould count≤ 10
      E.coliAbsent in 1 g
      Salmonella spp.Absent in 10 g
      Total aerobic microbial count (ChP)≤ 10²
      Total yeast and mould count (ChP)≤ 10¹
      E.coli (ChP)Absent in 1 g
      Salmonella spp. (ChP)Absent in 10 g
      DNases (Exo- and endonucleases) (not detectable)passes test
      RNases (not detectable)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.,NF,JP
      Global Trade Item Number
      Catalogue Number GTIN
      1027761000 04054839467196

      Documentation

      Material Qualification Dossier

      TitleVersion
      5.0

      Quality Management Dossier (Open Access)

      Title

      Operational Excellence Dossier

      Title

      Trehalose dihydrate SDS

      Title

      Safety Data Sheet (SDS) 

      Trehalose dihydrate Certificates of Analysis

      Product Number PackagingSpecificationLot Number
      1027761000 Plastic bottlePDF Specification Document

      Certificates

      Title