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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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