ICP-MS Method Validation Study of Arsenic, Cadmium, Mercury and Lead in Polyethylene Glycol Utilizing USP <233>

It’s official - the United States Pharmacopeia (USP) Elemental Impurities General Chapters <232> and <233> will replace the Heavy Metals Test, General Chapter <231>, as of December 1, 2015. At that time, omission of the original Heavy Metals Test <231> will be replaced with mandatory compliance of the new Elemental Impurities Test. We understand that there is much to consider when developing your strategy for compliance with these new regulations, from validation process to analytical techniques that will work best for your unique products. While no analytical laboratory provides specific instruction as to what compliance strategies or process validation protocols are best for your application, we can provide information on the available techniques to help you determine the option that might work best with your product.

As previously mentioned in “Understanding USP <233> - Instrumentation, Drug Testing Procedures, and Acceptance Criteria,” R.D. Laboratories has analyzed a comprehensive list of excipients, products, and substances for elemental impurities. More specifically, we have completed a Method Validation Study in support of an ICP-MS Trace Analysis for Arsenic, Cadmium, Mercury and Lead on a Polyethylene Glycol 3350 excipient under USP <233> Elemental Impurities Procedures. 

In an effort to help you understand the new testing requirements as well as our elemental impurities testing capabilities, we have released the ICP-MS Method Validation Study of Arsenic, Cadmium, Mercury and Lead in Polyethylene Glycol 3350 Utilizing USP <233>.

We at R.D. Laboratories are committed to being your partner in meeting the new testing requirements mandated by both the FDA and the USP. For more than thirty years, our specialty has been providing analytical services for the pharmaceutical industry. Throughout our history, we have made it a priority to master the latest methodologies and technologies needed to deliver the most accurate and timely results possible, all the while maintaining our reputation for superior customer service and communication.

Our goal is to help you meet the requirements of USP <232> and USP <233>. Click here to request a quote for testing implementation to meet your needs.

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