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LC3471 D(-)-Mannitol
fine powder suitable for use as excipient exp Ph Eur,BP,USP,JP,FCC,E 421

 

Order number Packaging Quantity Price €
AC30471 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 %
Particle size (> 150 µm) ≤ 2 %
Residual solvents (Ph. Eur./USP/ICH) excluded by manufacturing process
Microbiological test conforms
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