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

D(-)-Mannitol low endotoxin, (Ph. Eur., BP, USP, JP) pure, pharma grade
Content: 1 KGM
Physical Description:
Solid
Specification: Endotoxins:?max. 1 I.U./g
Assay (HPLC, calc. on dried subst.): 97.0 - 102.0 %
Appearance of solution: passes test
Identity: passes test
Conductivity (20 %; H2O; 25°C):?max. 20 µS/cm
Red. sugars (as Glc):?max. 0.1 %
Heavy metals (as Pb):?max. 0.0005 %
Loss on drying (4 h; 105°C):?max. 0.5 %
Melting point: 165 - 170°C
Salmonella: negative
E. coli: negative
Total aerobic microbial count:?max. 1000 CFU/g
Colony count (yeasts & moulds):?max. 100 CFU/g
Ni:?max. 0.0001 %
Related subst. (HPLC):
Impurity A:?max. 2.0 %
Sum of impurity B + C:?max. 2.0 %
Any unspecified impurity:?max. 0.10 %
Total impurities:?max. 2.0 %