Sucralose, in polvere, EMPROVE® Ph Eur, ChP, NF, JPE
Fornitore: 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
1.00894.0010
1.00894.1000
1.00894.0010EA
60.9
EUR
1.00894.0010
1.00894.1000
Sucralose, in polvere, EMPROVE® Ph Eur, ChP, NF, JPE
Sucralose
|
Formula:
C₁₂H₁₉Cl₃O₈ Peso molecolare: 397,63 g/mol Punto di fusione: 114,5 °C Densità: 1,62 g/cm³ (20 °C) Temperatura di stoccaggio: Room Temperature |
MDL Number:
MFCD03648615 CAS Number: 56038-13-2 EINECS: 259-952-2 UN: 1845 |
Risultati del test di specificazione
| 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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