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LC3473 D(-)-Mannitollow in endotoxins, suitable for use as an active pharmaceutical ingredient api Ph Eur,BP,USP,JP |
| Order number | Packaging | Quantity | Price € |
| AC30473 | Fibre carton | 50 kg | Inquire |
| Product information | |
| Grade | Ph Eur,BP,USP,JP,FCC,E 421 |
| Hill Formula | C6H14O6 |
| HS Code | 2905 43 00 |
| EC number | 200-711-8 |
| Molar mass | 182.17 g/mol |
| CAS number | 69-65-8 |
| Chemical and physical data | |
| Ignition temperature | 410 °C |
| Solubility | 213 g/l (25 °C) |
| Melting point | 164 – 169 °C |
| Molar mass | 182.17 g/mol |
| Density | 1.49 g/cm3 (20 °C) |
| Bulk density | 400 – 500 kg/m3 |
| pH value | 5 – 7 (100 g/l, H2O, 20 °C) |
| Boiling point | 290 – 295 °C (4 hPa) |
| Vapor pressure | (20 °C) |
| Viscosity kinematic | (20 °C) not applicable |
| Safety information | |
| RTECS | OP2060000 |
| 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. |
| Transport information | |
| Declaration (transport by sea) IMDG-Code | No Dangerous Good |
| Declaration (transport by air) IATA-DGR | No Dangerous Good |
| Toxicological data | |
| LD 50 oral | LD50 rat 13500 mg/kg |
| Specifications | |
| Assay (HPLC, calc. on dried substance) | 98.0 – 101.0 % |
| Identity (IR-spectrum) | passes test |
| Appearance of solution (20 %; water) | passes test |
| Acidity or alkalinity | passes test |
| Melting range – beginning |
≥ 164.0 °C |
| – end | 165.5 – 169.0 °C |
| Spec. rotation – α 20/D; 8 %, borate complex, calc. on dried substance |
+23 – +25 ° |
| – α 25/D; 1 %; molybdate complex, calc. on dried substance | +137 – +145 ° |
| conductivity (25°C) (20 %; water) | ≤ 20 µS/cm |
| Chloride (Cl) | ≤ 0.005 % |
| Sulphate (SO4) | ≤ 0.010 % |
| Heavy metals (as Pb) | ≤ 0.0005 % |
| As (Arsenic) | ≤ 0.00010 % |
| Ni (Nickel) | ≤ 0.0001 % |
| Pb (Lead) | ≤ 0.00005 % |
| Related substances (HPLC) – Sorbitol |
≤ 2.0 % |
| – Maltitol | ≤ 2.0 % |
| – Isomalt | ≤ 2.0 % |
| sum related substances | ≤ 2.0 % |
| Related substances (HPLC) – unknown impurities, single |
≤ 0.10 % |
| Reducing sugars (as glucose) | ≤ 0.05 % |
| Reducing sugars after hydrolysis/total sugar (as glucose) | ≤ 0.4 % |
| Sulfated ash | ≤ 0.1 % |
| Water | ≤ 0.5 % |
| Loss on drying (105 °C) | ≤ 0.30 % |
| Residual solvents (Ph. Eur./USP/ICH) | excluded by manufacturing process |
| Microbiological test | passes test |
| Colony count – aerobic bacteria (TAMC) |
≤ 2000 CFU/g |
| – Yeasts and moulds (TYMC) | ≤ 200 CFU/g |
| Salmonella spp. | in 10g Substance not detectable |
| E.coli | in 10g Substance not detectable |
| Staphylococcus aureus | in 10g Substance not detectable |
| Pseudomonas aeruginosa | in 10g Substance not detectable |
| Candida albicans | In 1g substance not detectable |
| Endotoxins (kinetic turbidimetric test) | ≤ 1 I.U./g |
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