D-(+)-Glucose monohydrate, EMPROVE® EXPERT Ph. Eur., USP, BP suitable for use as excipient, SAFC®
Supplier: MERCK PRODUCTION CHEMICALS
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About this item
Synonyms: (2S,3R,4S,5S,6R)-6-(Hydroxymethyl)tetrahydro-2H-pyran-2,3,4,5-tetraol hydrate, Dextrose monohydrate
CAS Number:14431-43-7
:5996-10-1
Formula:C₆H₁₂O₆·H₂O
MDL Number:MFCD00149450
:198.17 g/mol
Melting Pt:83 °C
Storage Temperature:Ambient
EINECS:200-075-1
Specifications
- Environmentally Preferable:
Specifications
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
Specification Test Results
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