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Merck - 1083469450 - D(+)-GLUCOSE MONOHYDRATE BP, DAB, PH EUR, U (Each)

  • MFR SKU: 1083469450
  • ITEM #: 9537059
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ITEM #: 9537059
D(+)-Glucose monohydrate^ D(+)-Glucose monohydrate suitable for use as excipient, Grade: EMPROVE exp Ph Eur, BP, USP, Cas No. 14431-43-7, Molecular formula: C6H12O6 * H2O, Synonyms: Dextrose, Size: 18x25kg
This listing is for Each

Merck - 1083469450 - D(+)-GLUCOSE MONOHYDRATE BP, DAB, PH EUR, U (Each)

  • Item #: 9537059
  • MFR SKU: 1083469450
  • Catalogue Number 108346
  • CAS number 77938-63-7
  • EC number 200-075-1
  • Grade Ph Eur, BP, JP, USP
  • Hill Formula CHO*HO
  • Molar Mass 198.17 g/mol
  • HS Code 1702 30 50
  • Structure formula Image
  • Quality Level MQ500
  • Density 0.62 g/cm3
  • Ignition temperature 500 ° C
  • Melting Point 146 ° C
  • pH value 4.0 - 6.0 (500 g/l, HO, 20 ° C)
  • Bulk density 630 kg/m3
  • Solubility 1000 g/l
  • LD 50 oral LD50 Rat 25800 mg/kg
  • Storage class 10 - 13 Other liquids and solids
  • WGK WGK 1 slightly hazardous to water
  • Storage Store at +15° C to +25° C.
  • Declaration (railroad and road) ADR, RID Kein Gefahrgut
  • Declaration (transport by air) IATA-DGR No Dangerous Good
  • Declaration (transport by sea) IMDG-Code No Dangerous Good
  • Assay (HPLC, calc. on anhydrous substance) Ph Eur 97.5 - 102.0 %
  • Assay (HPLC, calc. on anhydrous substance) USP 97.5 - 102.0 %
  • Assay (HPLC, calc. on anhydrous substance) JP 97.5 - 102.0 %
  • Identity (IR) passes test
  • Identity (wet chemistry) passes test
  • Identity (spec. rotation calc. on anhydrous substance) passes test
  • Identity (HPLC) passes test
  • Identity (water) passes test
  • Appearance of solution passes test
  • Color and clarity of solution passes test
  • Conductivity ≤ 20 µ S/cm
  • Heavy metals (as Pb) ≤ 4 ppm
  • Cu (Copper) ≤ 0.0025 %
  • Zn (Zinc) ≤ 0.0025 %
  • Related substances [sum of impurities A (maltose) and B (isomaltose)! ≤ 0.4 %
  • Related substances [Impurity C (maltotriose)! ≤ 0.2 %
  • Related substances [Impurity D (fructose)! ≤ 0.15 %
  • Related substances (unspecified impurities) ≤ 0.10 %
  • Related substances (Sum of all impurities) ≤ 0.5 %
  • Dextrin passes test
  • Soluble starch, sulfite ≤ 15 ppm
  • Residual solvents (ICH Q3C) excluded by manufacturing process
  • Water (according to Karl Fischer) 7.5 - 9.5 %
  • Endotoxins ≤ 2.5 I.U./g
  • Microbiological purity (Total aerobic microbial count (TAMC)) ≤ 1000 CFU/g
  • Microbiological purity (Total yeast and mould count (TYMC)) ≤ 100 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, JP, USP

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