Controlling elemental impurities has always been a critical issue within the pharmaceutical and medical device industry. Limits and procedures have recently been re-defined for heavy metals testing since the implementation of “International Conference on Harmonization – Guideline for Elemental Impurities” (ICH- Q3(D)) and the implementation of “USP General Chapters <232> Elemental Impurities- Limits”, and “USP General Chapters <233> Elemental Impurities – Procedures”, as of January 1, 2018.
ICP-MS is the best choice for elemental metals analysis due to its higher sensitivity, specificity and unique ability to monitor all metals simultaneously.
While the requirements of ICH-Q3(D) and the USP <232> and <233> are similar, there are key differences which can complicate study designs.
Atlantic Analytical has ICP-MS methods which are capable of monitoring metals required by both the ICH and USP, 24 versus 15 metals, respectively, with our standardized procedures for helping our clients address their regulatory requirements. Our routine practice for Parenterals (liquid matrix), Orals (solid matrix), and Inhalation Products (liquids and solids in a propellant) is the following:
- Initial screen of the drug product/substance/medium for the full array of metals.
- Method development for specific drug product/substance/medium.
- Method validation for element/product/medium specific procedure, as required.
- Routine samples analysis.