D-(+)-Glucose monohydrate, EMPROVE® EXPERT Ph. Eur., BP, USP, SAFC®
1.08346.9450
:
- Pk:450 kg
- Seq:4816
- 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
:
:198.17 g/mol
:83 °C
:Ambient
:200-075-1
:14431-43-7
:5996-10-1
:C₆H₁₂O₆·H₂O
:MFCD00149450