Assay (as CaO) (Compl.)..........................................................9,0-10,5 %

Assay (as Ca) (Compl.) calc. a.d.s..............................................6,4-7,4 %

Assay, fatty acid fraction (G.C.)

Stearic acid, minimum.................................................................... 40,0 %

Stearic + Palmitic acids, minimum................................................. 90,0 %

Identity according to Pharmacopoeias................................................ p/t.

MAX. IMPURITIES

Loss on drying at 105°C................................................................... 4,0 %

Residual solvents (Ph.Eur./USP)............................................................ p/t

Acidity or alkalinity............................................................................... p/t.

Chloride (Cl)...................................................................................... 0,1 %

Sulphate (SO4).................................................................................. 0,3 %

Heavy metals (as Pb).................................................................... 0,001 %

Total aerobic microbial count (TAMC)....................................... 1000 cfu/g

Total combined yeast and mounDs (TYMC)............................... 100 cfu/g

Escherichia coli.........................................................................absence/g

Salmonella............................................................................absence/10 g

As............................................................................................... 0,0003 %

Cd............................................................................................... 0,0003 %

Ni................................................................................................ 0,0005 %

Pb................................................................................................. 0,001 %