Merck - 1027769013 - Trehalose dihydrate

  • MFR SKU: 1027769013
  • ITEM #: 18509042
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ITEM #: 18509042
EMPROVE® EXPERT Ph Eur, ChP, NF, JP
This listing is for 12 kg Bucket, plastic

Merck - 1027769013 - Trehalose dihydrate

  • Item #: 18509042
  • MFR SKU: 1027769013
  • Catalogue Number 102776
  • Synonyms 1-O-alpha-D-Glucopyranosyl-alpha-D-glucopyranoside
  • CAS number 6138-23-4
  • EC number 202-739-6
  • Grade Ph Eur, ChP, NF, JP
  • Molar Mass 378.33 g/mol
  • HS Code 2940 00 00
  • Quality Level MQ500
  • Melting Point 96.5 - 97.5 ° C
  • Storage class 10 - 13 Other liquids and solids
  • WGK WGK 1 slightly hazardous to water
  • Disposal 3
  • 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.
  • Storage NoTempLimit
  • white 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 (SO) ≤ 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.coli Absent 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 ., NF, JP

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