OTC Drugs

Most drug products and active pharmaceutical ingredients (API’s) require purity assessments by techniques capable of detecting low levels of contaminants. Under California State legislation (Proposition 65), many pharmaceutical products, such as antacids and multivitamin supplements, and the raw materials used in their manufacture, such as Calcium and Magnesium Carbonates, are subject to strict purity limits. As a result, monitoring of lead in calcium containing over-the-counter medications has been mandatory in California since July 1, 1997. The detection limits required are beyond the abilities of conventional analytical techniques, such as graphite furnace AA and optical emission; however, they are easily attainable with inductively coupled plasma mass spectrometry (ICPMS).  
 
CANTEST employs ICPMS analysis for the determination of lead according to pharmaceutical industry protocol for the testing of this element in calcium containing finished products. ICPMS can measure below 0.05 µg/g (ppm) lead in tablets. CANTEST can also perform these analyses according to the United States FDA's cGMP requirements.