D(-)-Mannitol (USP, BP, Ph. Eur.) pure, pharma grade

D(-)-Mannitol (USP, BP, Ph. Eur.) pure, pharma grade
Content: 5 KGM
Physical Description:
solid
Quality Name: pure, pharma grade
Specification: Assay (calc. a.d.s.): 97.0 - 102.0 %
Identity according to Pharmacopoeias: passes test
Melting range: 165-170°C
Specific rotation a 20/D c=8 (in B4O7Na2.10H2O 10%): +23 - +25°

?maximum limit of impurities:
Appearance of solution (Ph-Eur): passes test
Appearance of solution (USP): passes test
Alkalinity: 0.006 meq/g
Insoluble matter in H2O: 0.01 %
Loss on drying at 105°C: 0.2%
Residue on ignition (as SO4): 0.1 %
Sugars Reducing (as C6H12O6): 0.1 %
Conductivity at 25°C (c=20% w/v in H2O): 20 uS.cm-1
Related substances:
Residual solvents (Ph.Eur/USP): passes test
D (-)-Sorbite: 2.0 %
Isomalt + Maltitol: 2.0 %
Unspecified impurities: 0.10 %
Total impurities: 2.0 %
Water (H2O): 0.5 %
Total combined yeast and moulds (TYMC): 100 cfu/ml
Total aerobic microbial count (TAMC): 1000 cfu/g
Salmonella: absence/10g
Escherichia coli: absence/g
Ni: 0.0001 %