Quantitative Elemental & Heavy Metal Testing (GMP ICP-MS)

Quantitative Elemental & Heavy Metal Testing (GMP ICP-MS)

 

For many years, levels of toxic metal impurities in pharmaceutical products have been controlled using the Heavy Metals Test described in chapter 241 of the USP National Formulary (USP-NF). This test, involving classical chemistry and visual interpretation, is now considered to lack the sensitivity and specifically to adequately monitor these metals, so the USP has proposed new chapters (232 and 233) to revise limits and test procedures that reflect the analytical technology now available. 

CHEMI Pharmaceutical has state of the art qualified GMP ICP-MS with digestive microwave that can confidently trace all elements in the periodic table to a trillion of a gram.

For more info on elemental impurities in pharmaceuticals, please refer to this FAQ page from U.S Pharmacopeial Convention.