At the end of 2017, pharmaceutical companies will be obliged to determine inorganic contaminants (heavy metals) in raw materials and finished pharmaceutical products. The primary aim is to surpass the old analysis directives and guarantee better living and working conditions.
The new unified procedure defined by the US Pharmacopeial Convention (USP) and the International Conference of Harmonisation (ICH) introduced the new standards USP. USP 232 shall determine daily limits of heavy metals based on the type of administration (oral, parenteral or inhalation), while USP 233 shall outline the sample preparation procedure and the instrumental techniques to use.
Through the use of closed-vessel microwave systems (which prevent the loss of volatile substances) and subsequent heavy metal detection using instrumental techniques such as ICP-OES and ICP-MS, Ambiente Analisi S.r.l. handles the entire pharmaceutical product mineralisation process.