Packs sizes (1)
Technical data
- Melting Point:
- 96 - 100 °C
- Solubility:
- Miscible with ethanol
- Physical Description:
- solid
- Product Code:
- 143064
- Product Name:
- D(-)-Sorbitol (USP-NF, BP, Ph. Eur.) pure, pharma grade
- Quality Name:
- pure, pharma grade
- Specifications:
- Assay: 98.0-100.5%
Identity according to Pharmacopoeias:: passes test
pH of 10 % solution w/w: 3.5-7.0
Specific rotation α 20/D c=10 (in B4O7Na2.10H2O 12.8%): +4.0 - +7.0°
Maximum limit of impurities
Appearance of solution: passes test
Acidity or alkalinity: passes test
Residue on ignition (as SO4): 0.1 %
Sugars Reducing (as C6H12O6): 0.2 %
Sugars Total sugars: 1 %
Chloride (Cl): 0.0050%
Sulfate (SO4): 0.010%
Conductivity sol. 20% a 20°C: 20 uS.cm-1
Related substances:
Individual: 2.0 %
Total: 3.0 %
Residual solvents (Ph.Eur/USP): passes test
Water (H2O): 1 %
Total combined yeast and moulds (TYMC): 100 cfu /g
Total aerobic microbial count (TAMC): 1000 cfu/g
Salmonella: absence/10g
Escherichia coli: absence/g
Microbial limits:: absence/g
Heavy metals (as Pb): 0.001%
Residual metals ICP: (according to EMEA/CHMP/SWP/4446/2000)
Class 1A (Pt, Pd): 10 ppm
Class 1B (Ir, Rh, Ru, Os): 10 ppm
Class 1C (Mo, Cr, V): 25 ppm
Class 2 (Cu, Mn): 250 ppm
Class 3 (Fe, Zn): 1,300 ppm
As: 0.00015 %
Cd: 0.00005 %
Hg: 0.00015 %
Ni: 0.0001 %
Pb: 0.00005 %
- WGK:
- nwg
- Storage:
- Room Temperature.
- Master Name:
- D(-)-Sorbite
- Synonyms Long Text:
- D-Glucitol, D-Sorbitol, Nivitin, Sorbol
- EINECS:
- 200-061-5
- CS:
- 29054411
