The presence of elemental impurities in pharmaceuticals samples is a concern due to the health hazards caused by contaminants. These impurities may adversely affect the stability of the drug and its shelf-life, which can cause unwanted side effects. In the United States, the limits and procedures used to monitor the contaminants, including elemental impurities, in pharmaceutical materials are defined by the United States Pharmacopeia (USP) and the Food and Drug Administration (FDA).
After recognizing the technical issues with the current 100-years old colorimetric test described in USP <231>, USP developed a new program that includes USP <232>/<233> and <2232>. The upgraded program has new instrumental methods that are more reliable, accurate, sensitive, specific and robust.
USP<232> specifies the limits for the amount of elemental impurities (heavy metals) whereas USP <233> specifies the analytical procedures for the evaluation of the levels of these elemental impurities. The heavy metals are: Cadmium, Lead, Arsenic, Mercury, Indium, Osmium, Palladium, Platinum, Rhodium, Ruthenium, Chromium, Molybdenum, Nickel, Vanadium, and Copper.
USP <2232> describes the limits of the amount of elemental contaminants (Arsenic, Cadmium, Lead and Mercury) in finished dietary supplement dosage form.
EMSL Analytical, Inc. has extensive experience in analyzing heavy metals in various matrices. This experience and advanced training allows us to offer high quality analysis with GMP validated state-of the-art ICP-MS instrumentation that has the ability to choose the use of collision or reaction cell techniques for optimum performance. The digestion of the samples is performed in high-performance, validated, microwave digestion systems.
EMSL is FDA registered and DEA licensed.