EMSL Analytical, Inc. Announces Elemental Impurities Testing According to USP 232, 233 & USP 2232

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 year-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 a trusted leader in trace metal analysis in the environmental chemistry community, which is now offering a secure partnership to meet the requirements of USP Chapters 232, 233 and 2232. EMSL is FDA registered and DEA licensed.

To learn more about EMSL’s elemental impurities testing services, please visit www.EMSL.com, call (800) 220-3675 or email info@EMSL.com .
 
About EMSL Analytical, Inc.
EMSL Analytical is a nationally recognized and locally focused provider of environmental, food, pharmaceutical, and materials testing services and products to professionals and the general public.  The company has an extensive list of accreditations from leading organizations as well as state and federal regulatory agencies. 
   

Contact Information

Joe Frasca

Senior Vice President of Marketing

EMSL Analytical, Inc.

(1) (856) 303-2503

Contact via E-mail