Heavy Metals
Expanded USP <232> List
Method Description
This method determines elemental impurities in accordance with USP <232>, which establishes limits for a broader range of toxic elements—including, but not limited to, arsenic, cadmium, mercury, and lead—in drug substances, excipients, and finished products. In contrast to targeted heavy metal panels that focus on four commonly monitored elements, this approach evaluates additional elemental impurities that may be introduced through raw materials, manufacturing processes, or environmental contamination. These elements can pose significant health risks due to their potential for toxicity and accumulation in the body. The analysis ensures that products meet established safety limits for elemental impurities, supporting regulatory compliance and protecting consumer health.
Analyte List
| Analyte Name | CAS # | Type |
|---|---|---|
| Antimony | 7440-36-0 | Measured |
| Arsenic | 7440-38-2 | Measured |
| Barium | 7440-39-3 | Measured |
| Cadmium | 7440-43-9 | Measured |
| Chromium | 7440-47-3 | Measured |
| Cobalt | 7440-48-4 | Measured |
| Copper | 7440-50-8 | Measured |
| Gold | 7440-57-5 | Measured |
| Iridium | 7439-88-5 | Measured |
| Lead | 7439-92-1 | Measured |
| Lithium | 7439-93-2 | Measured |
| Mercury | 7439-97-6 | Measured |
| Molybdenum | 7439-98-7 | Measured |
| Nickel | 7440-02-0 | Measured |
| Platinum | 7440-06-4 | Measured |
| Rhodium | Measured | |
| Thallium | 7440-28-0 | Measured |
| Tin | 7440-31-5 | Measured |
Technical Data Sheet
Additional information
Sample digestion and ICP-MS quantitation follow USP <233>; results can be assessed against the USP <232> permitted daily exposure limits or product-specific specifications on request. Reported in µg/g (ppm) per element.
Heavy Metals
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