Sucralose, powder, EMPROVE® Ph Eur, ChP, NF, JPE
Supplier: MERCK PRODUCTION CHEMICALS
Synonyms:
Trichlorosucrose, (2R,3R,4R,5R,6R)-2-(((2R,3S,4S,5S)-2,5-Bis(chloromethyl)-3,4-dihydroxytetrahydrofuran-2-yl)oxy)-5-chloro-6-(hydroxymethyl)tetrahydro-2H-pyran-3,4-diol, 1-(1,6-Dichloro-1,6-dideoxy-beta-D-fructofuranosyl)-4-chloro-4-deoxy-alpha-D-galactopyranoside
M-Clarity™ quality level = MQ500 (more info.)
1.00894.0010
1.00894.1000
1.00894.0010EA
71
GBP
1.00894.0010
1.00894.1000
Sucralose, powder, EMPROVE® Ph Eur, ChP, NF, JPE
Sucralose
Formula:
C₁₂H₁₉Cl₃O₈ MW: 397,63 g/mol Melting Pt: 114,5 °C Density: 1,62 g/cm³ (20 °C) Storage Temperature: Room Temperature |
MDL Number:
MFCD03648615 CAS Number: 56038-13-2 EINECS: 259-952-2 UN: 1845 |
Specification Test Results
Assay (HPLC, calc. on anhydrous substance) | 98.0 - 102.0 % |
Assay (HPLC, calc. on anhydrous substance) (ChP) | 98.0 - 102.0 % |
Assay (calc. on anhydrous substance) (JPE) | 98.0 - 102.0 % |
Appearance of substance (description) | balled powder |
Appearance of substance (color) | almost white |
Identity (HPLC) | conforms |
Identity (TLC) | conforms |
Identity (IR) | conforms |
Identity (Spec. rotation (Ph Eur)) | conforms |
Spec. Rotation [α²0/D (calc. on anhydrous substance) (Ph Eur/JPE) | +84.0 - +87.5 ° |
Spec. Rotation [α²0/D (calc. on anhydrous substance) (NF/ChP) | +84.0 - +87.5 ° |
Appearance of solution (10 %, water) | conforms |
pH-Test | Decrease of 1 pH unit max. |
Heavy metals (as Pb) | ≤ 0.0010 % |
Methanol | ≤ 0.1 % |
Methanol (ChP) | ≤ 0.1 % |
Cyclohexane | ≤ 3880 ppm |
N,N-Dimethylformamide | ≤ 880 ppm |
Acetic acid | ≤ 5000 ppm |
Ethyl acetate | ≤ 5000 ppm |
Hydrolysis products | ≤ 0.1 % |
Impurities H and I | ≤ 0.1 % |
Monosaccharide-Chloride (as Fructose) | ≤ 0.16 % |
Related substances (Ph Eur/ChP) | ≤ 0.5 % |
Related substances (NF) | ≤ 0.5 % |
Other Disaccharide-Chlorides | ≤ 0.5 % |
Triphenylphosphine oxide | ≤ 150 ppm |
Residue on ignition | ≤ 0.7 % |
Water (according to Karl Fischer) | ≤ 2.0 % |
Particle Size (d90) | ≤ 12 µm |
Microbiological purity (Total aerobic microbial count (TAMC)) | ≤ 1E+03 CFU/g |
Microbiological purity (Total yeast and mould count (TYMC)) | ≤ 1E+02 CFU/g |
Bile tolerant Gram negative Bacteria (absent in 1 g) | conforms |
Escherichia coli (absent in 1 g) | conforms |
Pseudomonas aeruginosa (absent in 1 g) | conforms |
Staphylococcus aureus (absent in 1 g) | conforms |
Candida albicans (absent in 1 g) | conforms |
Salmonella ssp (absent in 10 g) | conforms |
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