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

Fournisseur: MilliporeSigma

Certificats

Fournisseur: MilliporeSigma

Certificats

A propos de cet article

Synonymes: Corn sugar,Glucose,D-(+)-Dextrose,(2R,3S,4R,5R)-2,3,4,5,6-Pentahydroxyhexanal,Glucolin,Dextrose

Numéro CAS:50-99-7

:492-62-6

Formule:C₆H₁₂O₆

MW:180.16 g/mol

Numéro MDL:MFCD00148912

:Storage Temperature: Ambient

:Length:

:Width:

:Height:

:Ø

:Thickness:

:Boiling Pt:

:Melting Pt:

:Melting Pt: 146 °C

:Flash Pt:

:M.W. 180.16 g/mol

:D-(+)-Glucose

:146

Température d'entreposage:Ambient

:12,04467

:14,04459

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Résultats des tests de spécification

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