DiTEBA Publishes 5 Page Whitepaper: Impact of Proposed Changes to USP 231 Heavy Metals Testing
DiTEBA is pleased to announce the publication of it's latest whitepaper authored by Dr. Theo Kapanadze. This whitepaper investigates the impact of proposed changes to USP <231> for heavy metals analysis for the analysis of pharmaceutical ingredients and products.
Industry criticism of this dated method began around 15 years ago and sparked the revision process by the United States Pharmacopeia (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, many companies may not yet have the instrumentation in place and will need to either purchase new equipment or send their testing to contract testing laboratories. This whitepaper explores the implications associated with this proposed change by the United States Pharmacopeia.
Dr. Kapanadze has posted an article on Diteba's Blog that provides more information on this whitepaper and how you can get the whitepaper.