Sigma-Aldrich D(+)-Glucose Anhydrous 50 Kg

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M-Clarity Program

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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
Titrable acid: ≤ 0.002 meq/g
Conductivity: ≤ 20 µS/cm
Spec. rotation (α25/D): 52.5 - 53.0 °
In water insoluble matter: ≤ 0.005 %
Chloride (Cl): ≤ 0.01 %
Sulfate (SO₄): ≤ 0.005 %
Heavy metals (as Pb): ≤ 5 ppm
Fe (Iron): ≤ 5 ppm
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
Starch: passes test
Residual solvents (ICH Q3C): excluded by the manufacturing process
Loss on drying (105 °C): ≤ 0.2 %
Water (according to Karl Fischer): ≤ 1.0 %
Sulfated ash (600 °C): ≤ 0.02 %
Microbiological purity(Total aerobic microbial count (TAMC)): ≤ 100 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
Endotoxins: ≤ 10 I.U./g
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,ACS

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