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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

EC Number: 202-739-6 Hill Formula: C₁₂H₂₂O₁₁*2H₂O CAS #: 6138-23-4 Molar Mass: 378.33 g/mol Grade: Ph Eur,ChP,NF,JP
102776
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Key Specifications Table

CAS #EC NumberHill FormulaMolar MassGrade Value
6138-23-4 202-739-6 C₁₂H₂₂O₁₁*2H₂O 378.33 g/mol Ph Eur,ChP,NF,JP

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1027761000
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      1027769013
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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
          Hill FormulaC₁₂H₂₂O₁₁*2H₂O
          Molar Mass378.33 g/mol
          HS Code2940 00 00
          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
          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

          Documentation

          Material Qualification Dossier

          TitleLot Number
          1.0

          Quality Management Dossier

          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
          1027769013 Bucket, plasticPDF Specification Document

          Certificates

          Title