New 5 Page Whitepaper: Impact of Proposed Changes to USP 231 Heavy Metals Testing
First introduced over 100 years ago, USP<231> is a colorimetric procedure based on the precipitation of insoluble metal sulfides. This test for heavy metals is qualitative rather than quantitative. It is not an element specific method, nor is it equally sensitive to each metal. The limits specified by the test are based on the ability to observe the precipitate, rather than on the analysis of toxicological data. The procedure does not necessarily detect all potential forms and/or valences of elements of concern when they are present as the oxo ions or in the organometallic form. Chromium and nickel are potential contaminants from modern stainless steel processing equipment and are not detected by the USP<231> test method. Other studies indicate inconsistent recoveries of monitor and standard solutions using USP<231> method II.2, 3
Industry criticism of this dated method began around 15 years ago and sparked the revision process by the USP. The USP is now proposing that USP<231> be revised to USP<232> which will require the use of updated instrumental technology to improve selectivity and sensitivity of heavy metals test. This will constitute a serious change for the pharmaceutical industry that will shift the testing from a relatively inexpensive procedure to tests that require expensive instrumentation and highly skilled metals analysts.
This whitepaper can assist you with:
Discovering how these changes will impact the way you test for heavy metals
Identifying and examining the different instrument approaches available for you to to meet these new guidelines for heavy metal analysis
Evaluating the advantages and disadvantages of the different analytical testing approaches available for heavy metals testing and what the cost implications are to you
Because of the associated cost of new instrumentation and/or outsourcing for the testing of heavy metals, you may not yet have the instrumentation in place and will need to either purchase the new equipment or send their testing to contract testing laboratories. This whitepaper can help you explore all of the implications associated with this proposed change by the United States Pharmacopeia.