Assay  

99,0-101,0%

Identity :

Identity according to Pharmacopoeias:

passes test

Maximum limit of impurities

Appearance of solution

passes test

Insoluble matter in H2O

passes test

Chloride (Cl) 

0,005%

Nitrogen compounds (as N)

0,005%

Sulfate (SO4) 

0,005%

Heavy metals (as Pb)

0,002%

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)

1.300 ppm

As

0,0001     %

Pb

0,002      %