100894
Sucralose powder
suitable for use as excipient EMPROVE® exp NF
For general questions please contact our Customer Service:
Merck KGaA
Frankfurter Str. 250
64293 Darmstadt
Germany
Phone: +49 6151 72-0
Fax: +49 6151 72 2000
31 July 2010
loading
| Product information | |||
|---|---|---|---|
| Grade | NF | ||
| Hill Formula | C12H19Cl3O8 | ||
| HS Code | 2932 19 00 | ||
| EC number | 259-952-2 | ||
| Molar mass | 397.63 g/mol | ||
| CAS number | 56038-13-2 | ||
| Chemical and physical data | |||
|---|---|---|---|
| Solubility | 300 g/l (25 °C) | ||
| Melting point | 130 °C (decomposition) | ||
| Molar mass | 397.63 g/mol | ||
| pH value | 6 - 8 (100 g/l, H2O, 20 °C) | ||
| Safety information | |||
|---|---|---|---|
| RTECS | LW5440140 | ||
| Storage class | 10 - 13 Other liquids and solids | ||
| WGK | NWG not water endangering | ||
| Disposal |
3 Relatively unreactive organic reagents should be collected in container A. If halogenated, they should be collected in container B. For solid residues use container C. |
||
| Toxicological data | |||
|---|---|---|---|
| LD 50 oral | LD50 rat > 10000 mg/kg | ||
| Specifications | |
|---|---|
| Assay (calc.on anhydrous substance) | 98.0 - 102.0 % |
| Appearance of substance - description | balled powder |
| - colour | almost white |
| Identity - HPLC | passes test |
| - TLC | passes test |
| - IR | passes test |
| Spec. rotation [α]20/D (calc.on anhydrous substance) | +84.0 - +87.5 ° |
| pH-Test | Decrease of 1 pH unit max. |
| Heavy metals (as Pb) | ≤ 0.001 % |
| As (Arsenic) | ≤ 3 ppm |
| Pb (Lead) | ≤ 1 ppm |
| Methanol | ≤ 0.1 % |
| Other residual solvents (Ph.Eur./USP/ICH) | excluded by production process |
| Product of Hydrolysis | ≤ 0.1 % |
| Related substances (DC) | ≤ 0.5 % |
| 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 |
| - 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 |
| Residues of metal catalysts or metal reagents acc. to EMEA/C HMP/SWP/4446/2000 are not likely to be present. | |
| Manufactured by Tate & Lyle | |
