D-(+)-Glucose, anhydrous, EMPROVE® EXPERT ACS, Ph. Eur., BP, USP, SAFC®
Supplier: MilliporeSigma
Synonyms:
Corn sugar
, D-Glucose
, D-(+)-Dextrose
, Glucolin
, ᴅ-(+)-Glucose
, (2R,3S,4R,5R)-2,3,4,5,6-Pentahydroxyhexanal
, Glucose
, Dextrose
1.37048.9029
1.37048.5000
1.37048.9029
1.37048.9012
1.37048.9012
1.37048.5000
1.37048.9050
EM1.37048.5000CS
702.46
USD
EM1.37048.5000
EM1.37048.9012
EM1.37048.9050
CA1.37048.9029
EM1.37048.9029
CA1.37048.9012
CA1.37048.5000
D-(+)-Glucose, anhydrous, EMPROVE® EXPERT ACS, Ph. Eur., BP, USP, SAFC®
D(+)-Glucose
Formula:
C₆H₁₂O₆ MW: 180.16 g/mol Storage Temperature: Ambient |
MDL Number:
MFCD00148912 CAS Number: 50-99-7 |
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 |
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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