Century-old testing procedure about to change
- New tests for impurities in active pharmaceutical ingredient (API) will be introduced via the United States Pharmacopeia and the National Formulary in early 2015.
- These tests will replace the 100-year-old heavy metals test.
- .The goals of this change are to improve patient safety and modernize API testing.
The heavy metals test is outdated and sometimes fails to detect potentially harmful elements. Under new regulations, API makers will be obligated to test all catalytic metals used to create the API. They will also have to identify the 'big four' -- cadmium, lead, arsenic and mercury -- in each batch of API. In addition, inductively coupled plasma mass spectrometry must be used to perform the tests.