Proposed revisions for General Chapters <232>, <233>, suggested for a May 1, 2014 implementation date, has been deferred. As such, there is no requirement for ANY drug product in the USP-NF to comply with the proposed USP <232>, <233> at this present time.
“There are key issues with the proposed USP <232>, <233> in preparation”, stated Dr. James Menoutis, CEO of Quantex Laboratories and President of NJ Institute of Chemists. “The main concern is that many laboratories do not have the necessary fundamental experience and skill level in dealing with preparation- which is critical for elemental impurities. ICP or ICP-MS instrumentation is only 49% of the challenge; the other 51% is having the understanding of application when dealing with complex preparations,” explained Dr. Menoutis.
The USP will work closely with ICH Q3D to “align their activities with the implementation of General Chapters <232>, <233>” and is planning to form an Advisory Group to further assist with carrying out General Chapters <232> ,<233>.