Sucrose, EMPROVE® ESSENTIAL NF, JP, Ph. Eur., BP, ChP suitable for use as excipient low in endotoxins, SAFC®
: β-ᴅ-Fructofuranosyl-α-ᴅ-glucopyranoside, α-ᴅ-Glucopyranosyl β-ᴅ-fructofuranoside, D(+)-Saccharose, α-ᴅ-Glc-(1→2)-β-ᴅ-Fru, Sucrose
:57-50-1
:
:C₁₂H₂₂O₁₁
:MFCD00006626
:13,08966
:185.5 °C
:1.59 g/cm³ (25 °C)
:M-Clarity™ quality level = MQ500 (more info.)
:342.3 g/mol
:Ambient
:200-334-9
- Environmentally Preferable:
- Identity (wet chemistry):passes test
- Identity (IR):passes test
- Appearance of solution (50 %; water):passes test
- Color of solution:passes test
- Color number:≤ 45
- Spec. rotation (α 20/D; 26 %; water):66.3 - 67.0 °
- Spec. rotation (α 20/D; 10 %; water):66.3 - 67.0 °
- Electrical conductivity:≤ 35 µS/cm
- Sulfite (as SO₂):≤ 10 ppm
- Sulfate (SO₄):≤ 0.05 %
- Heavy metals (as Pb):≤ 0.0005 %
- Ca (Calcium):≤ 0.05 %
- Dextrins:passes test
- Reducing sugars:passes test
- Reducing sugars (ChP):≤ 0.10 %
- Residual solvents (ICH Q3C):excluded by production process
- Loss on Drying (105 °C):≤ 0.1 %
- Sulfated ash:≤ 0.1 %
- Endotoxins:< 2
- Microbiological purity (Total aerobic microbial count (TAMC)):≤ 500 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
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