USP <232>

  • The chapter USP <232> specifies limits for the amounts (Permissible Daily Exposure) of elemental impurities (As, Cd, Hg, Pb, Cr, Cu, Ir, Mo, Ni, Os, Pd, Pt, Ru, Rh, V) in drug products whatever the route of administration.
  • A risk-based control strategy can be used to assure compliance with these limits. 
  • General chapters USP <232> “Elemental impurities – Limits” and USP <233> “Elemental Impurities – Procedures” became official on the 1st of February 2013.
  • As published in the Second Supplement to USP 38-NF 33, USP<232> specifications for elemental impurities now agree with ICH Q3D specifications but not for the list of elemental impurities. USP 38-NF 33 will become official on the 1st of December 2015
  • The General Chapter <232> will be applicable on the 1st of January 2018, the General Chapter USP<231> will remain in effect until this date.