USP 232 Oral Impurities Standards
Limits for the amounts of elemental impurities in drug products are specified by The United States Pharmocopeia (USP) and the International Conference on Harmonization (ICH). The following standards are based off these limits as detailed in USP General Chapter 232 and ICH Guideline for Elemental Impurities Q3D. Standards based on oral permitted daily exposures are provided along with an internal standard. High and low level multi-element calibration standards that allow quantitative analysis through custom applications will be available soon.
USP 232 Oral Impurities Mix 1
USP-232-01-1 100 mL
Varied conc. in 2-5% Nitric Acid 4 comps.
Arsenic15 µg/mL
Cadmium5 µg/mL
Lead5 µg/mL
Mercury30 µg/mL

USP 232 Oral Impurities Mix 2
USP-232-02-1 100 mL
Varied conc. in 2-5% Nitric Acid 6 comps.
Cobalt50 µg/mL
Nickel200 µg/mL
Selenium150 µg/mL
Silver150 µg/mL
Thallium8 µg/mL
Vanadium100 µg/mL

USP 232 Oral Impurities Mix 3
USP-232-03-1 100 mL
100 µg/mL in 10% Hydrochloric acid 7 comps.
Gold100 µg/mL
Iridium100 µg/mL
Osmium100 µg/mL
Palladium100 µg/mL
Platinum100 µg/mL
Rhodium100 µg/mL
Ruthenium100 µg/mL

USP 232 Oral Impurities Mix 4
USP-232-04-1 100 mL
Varied conc. in 2-5% Nitric Acid, tr HF 7 comps.
Antimony120 µg/mL
Barium140 µg/mL
Chromium1100 µg/mL
Copper300 µg/mL
Lithium55 µg/mL
Molybdenum300 µg/mL
Tin600 µg/mL

USP 232 Internal Standard
USP-232-05-1 100 mL
Varied conc. in 2-5% Nitric Acid, tr HCl, tr HF 6 comps.
Bismuth5 µg/mL
Germanium5 µg/mL
Indium5 µg/mL
Lutetium5 µg/mL
Scandium10 µg/mL
Tellurium25 µg/mL