EMEA/CHMP/SWP/4446/2000
Panreac Química is ahead of Pharmaceutical Industry requirements.
EMEA published EMEA/CHMP/SWP/4446/2000 guideline in February 2008. It is a guideline that recommends maximum acceptable concentration limits for the residues of metal catalysts or metal reagents that may be present in pharmaceutical substances or in drug products.
As a manufacturers of pharmaceutical raw materials, we are working to include these specifications in our CODEX products.
The metals are classified in the guide as follows:
Class 1A (Pt, Pd) .................................... max. 10 ppm
Class 1B (Ir, Rh, Ru, Os) ......................... max. 10 ppm
Class 1C (Mo, Ni, Cr, V) .......................... max. 25 ppm
Class 2 (Cu, Mn) ..................................... max. 250 ppm
Class 3 (Fe, Zn) ...................................... max. 1300 ppm
You can find the list of these products in the attached excel file, which will be updated monthly with the products that Panreac is analyzing residual metals.
