D-(-)-Fructose, EMPROVE® ESSENTIAL USP, Ph. Eur., BP, FCC, extra pure suitable for use as excipient, SAFC®

D-(-)-Fructose, EMPROVE® ESSENTIAL USP, Ph. Eur., BP, FCC, extra pure suitable for use as excipient, SAFC®

: D(-)-Levulose, (3S,4R,5R)-1,3,4,5,6-pentahydroxyhexan-2-one, β-D-(-)-Fructose, Fructose

:57-48-7

:C₆H₁₂O₆

:MFCD00148910

:552

:100…104 °C (dec.)

:1.59 g/cm³ (20 °C)

:180.16 g/mol

:13,04295

:Ambient

:200-333-3

Assay (α 20/D, 100 g/l, water, calc. on anhydrous substance):
98.5 - 101.2 %
Assay (α 25/D, 100 g/l,water, calc. on anhydrous substance):
98.0 - 102.0 %
Identity:
passes test
Appearance of solution (EP):
passes test
Appearance of solution (USP):
passes test
Acidity or alkalinity:
passes test
Spec. rotation (α 20/D; 10 %; water; calc. on anhydrous substance):
-93.5 - -91.0 °
Spec. rotation (α 25/D; 10 %; water; calc. on anhydrous substance):
-90.8 - -87.2 °
Chloride (Cl):
≤ 0.01 %
Sulfate (SO₄):
≤ 0.02 %
Heavy metals (as Pb):
≤ 0.0005 %
As (Arsenic):
≤ 0.0001 %
Ba (Barium):
passes test
Calcium and Magnesium (as Ca):
≤ 0.005 %
Cu (Copper):
≤ 0.0025 %
Pb (Lead):
≤ 0.00001 %
Zn (Zinc):
≤ 0.0025 %
Glucose (HPLC):
≤ 0.5 %
Foreign sugars:
passes test
5-Hydroxymethylfurfural and related substances:
passes test
Residual solvents (ICH Q3C):
excluded by the production process
Sulfated ash:
≤ 0.1 %
Water:
≤ 0.5 %