Technical / White Paper
Container Testing: Quantifying Metal Contaminants
Regulatory Agencies have clearly established the need to identify and control harmful chemicals which may leach from container closure systems into the final packaged drug product.
But USP <661> colorimetric methods for detecting heavy metal contaminants are known to be inadequate for identification and quantification of these contaminants at the trace levels where they exhibit potential toxicity.
SGS conducted a series of experiments to measure the impact of extraction, solvent, and detection techniques using proposed USP <232> methodology.
Read about the findings in our technical bulletin.