D-(+)-Glucose monohydrate, EMPROVE® EXPERT Ph. Eur., BP, USP, SAFC®

Supplier: MilliporeSigma

Synonyms: Dextrose monohydrate(2S,3R,4S,5S,6R)-6-(Hydroxymethyl)tetrahydro-2H-pyran-2,3,4,5-tetraol hydrate

1.08346.9450 1.08346.9029 1.08346.9029 1.08346.9450
EM1.08346.9450EA 20031.44 USD
EM1.08346.9450 CA1.08346.9029 EM1.08346.9029 CA1.08346.9450
D-(+)-Glucose monohydrate, EMPROVE® EXPERT Ph. Eur., BP, USP, SAFC®
D(+)-Glucose monohydrate

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 (*).

Certifications: corresponds to Ph Eur, BP, USP

Formula: C₆H₁₂O₆·H₂O
MW: 198.17 g/mol
Melting Pt: 83 °C
Storage Temperature: Ambient
MDL Number: MFCD00149450
CAS Number: 14431-43-7
EINECS: 200-075-1

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Specification Test Results

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

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