Assay (C3H6O3)........................................................................88,0-92,0 %

Minimum assay (as S-enantiomer)................................. 95,0 % of C3H6O3

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

Density at 20/20......................................................................... 1,20-1,21

MAX. IMPURITIES

Appearance.......................................................................................... p/t.

Ether-insoluble substances.................................................................. p/t.

Insoluble matter in H2O......................................................................... p/t.

Residue on ignition (as SO4)........................................................... 0,05 %

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

Darkened substances by H2SO4........................................................... p/t.

Sugars and other reducing substances............................................... p/t.

Citric, oxalic and phosphoric aciDs...................................................... p/t.

Volatile fatty aciDs................................................................................ p/t.

Chloride (Cl).................................................................................. 0,002 %

Sulphate (SO4).............................................................................. 0,002 %

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

As............................................................................................... 0,0001 %

Ca................................................................................................... 0,02 %

Residual metals ICP: (according to EMEA/CHMP/SWP/4446/2000)

Class 1A (Pt, Pd)........................................................................... 10 ppm

Class 1B (Ir, Rh, Ru, Os)................................................................ 10 ppm

Class 1C (Mo, Ni, Cr, V)................................................................. 25 ppm

Class 2 (Cu, Mn).......................................................................... 250 ppm

Class 3 (Fe, Zn).......................................................................... 1300 ppm