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°§CHAR(13) + CHAR(10) 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 %