ELEMENTAL IMPURITIES

As of January 1st 2018, USP <232> (Elemental Impurities-Limits) and USP <233> (Elemental Impurities-Procedures) has replaced USP <231> Heavy Metals limit test. BHP works in partnership with leading manufacturers to deliver sampling, testing and product release services for the pharmaceutical industry. This includes the digestion and analysis of various materials for Elemental Impurities to USP <232> and USP <233> using ICP-OES and ICP-MS.

BHP can offer the following:

  • Raw material, excipient, API and finished product testing

  • Closed vessel microwave digestion to prevent loss of volatile analytes such as Hg

  • Material-specific product development testing, including validation to ICH/USP guidelines

CAN WE HELP YOU?