Assay.....................................................................................98,0-100,5%
Identity according to Phamacopoeias.................................................. p/t.
Specific rotation [ï¡]20/D c=10 (in B4O7Na2.10H2O 12,8%)......+4,0 to +7,0°
pH of 10% w/w solution................................................................. 3,5-7,0
MAX. IMPURITIES
Appearance of solution........................................................................ p/t.
Conductivity of 20% sol. at 20°C..............................................20 μS.cm-1
Residue on ignition (as SO4)............................................................. 0,1 %
Residual solvents (Ph.Eur./USP)........................................................... p/t.
Acidity or alkalinity............................................................................... p/t.
Reducing sugars (as C6H12O6)........................................................... 0,2 %
Total sugars.........................................................................................1 %
Water (H2O)....................................................................................... 1,0 %
Related substances:
Individual peak....................................................................................2 %
Total.....................................................................................................3 %
Chloride (Cl)................................................................................ 0,0050 %
Sulphate (SO4).............................................................................. 0,010 %
Heavy metals (as Pb).................................................................... 0,001 %
Microbiological limits:
Total aerobic microbial count (TAMC)....................................... 1000 cfu/g
Total combined yeast and mounds (TYMC)............................... 100 cfu/g
Salmonella............................................................................absence/10 g
Escherichia coli.........................................................................absence/g
As............................................................................................... 0,0003 %
Ni................................................................................................ 0,0001 %
Pb............................................................................................. 0,00005 %
