Assay (as CaHPO4)(Compl.)...................................................98,0-101,0%
Identity according to Pharmacopoeias................................................ p/t.
MAX. IMPURITIES
Insoluble matter in HCl..................................................................... 0,2 %
Residual solvents (Ph.Eur./USP)........................................................... p/t.
Loss on ignition..........................................................................6,6-8,5 %
Loss on drying at 150°C................................................................... 2,0 %
Carbonate............................................................................................. p/t.
mono and tri-Calcium phosphate........................................................ p/t.
Chloride (Cl).................................................................................. 0,033 %
Fluoride (F).................................................................................... 0,005 %
Sulphate (SO4).................................................................................. 0,5 %
Total aerobic microbial count (TAMC)...................................... 1.000 cfu/g
Total moulds count (TMC).......................................................... 100 cfu/g
Total yeast count (TYC).............................................................. 100 cfu/g
Escherichia coli.........................................................................absence/g
Staphylococcus aureus.............................................................absence/g
Pseudomonas aeruginosa.........................................................absence/g
Salmonella.............................................................................absence/10g
Heavy metals (as Pb).................................................................... 0,003 %
As............................................................................................... 0,0003 %
Ba......................................................................................................... p/t.
Fe.................................................................................................... 0,04 %
