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1.08346 SAFC

D-(+)-Glucose monohydrate

Emprove® Expert, Ph. Eur., BP, JP, USP

Synonym: Dextrose monohydrate, Dextrose

  • CAS Number 14431-43-7

  • Empirical Formula (Hill Notation) C6H12O6 · H2O

  • Molecular Weight 198.17

  •  Beilstein/REAXYS Number 5250278

  •  MDL number MFCD00149450

  •  EC Index Number 200-075-1

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Properties

Related Categories APIs (Active Pharmaceutical Ingredients) and Excipients, Binders & Fillers, Biopharmaceutical Process Development and Manufacturing, Excipients, Liquid Dosage Forms,
Agency/Method   BP
  JP
  Ph. Eur.
  USP
Quality Level   500
description   EMPROVE® EXPERT Ph Eur,BP,USP
product line   Emprove® Expert
autoignition temp.   500 °C
potency   25800 mg/kg LD50, oral (Rat)
pH   6-7 (20 °C, 100 g/L in H2O)
mp   83 °C
bulk density   630 kg/m3
SMILES string   O.OC[C@@H](O)[C@@H](O)[C@H](O)[C@@H](O)C=O
InChI   1S/C6H12O6.H2O/c7-1-3(9)5(11)6(12)4(10)2-8;/h1,3-6,8-12H,2H2;1H2/t3-,4+,5+,6+;/m0./s1
InChI key   SPFMQWBKVUQXJV-BTVCFUMJSA-N
storage conditions   Store at +15°C to +25°C.

Description

Application

The specification of the product is part of the Emprove® Material Qualification Dossier and can be found under "General Properties".

Analysis Note

Assay (calc. on anhydrous substance): 97.5 - 102.0 %
Identity (IR): 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 µS/cm
Heavy metals (as Pb): ≤ 5 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 manucaturing 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, USP

Legal Information

Emprove is a registered trademark of Merck KGaA, Darmstadt, Germany

Safety & Documentation

Safety Information

Safety Information for this product is unavailable at this time.

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