Have you checked your calendar lately? The USP guidelines for elemental impurities, Chapters <232>, <233> and <2232> are scheduled to be implemented in less than 1 year from now! Hopefully you’re not reading this and saying “there are new USP guidelines?” If you are, don’t worry – we’re not judging – but you should brush up a bit on the new requirements here.
If you’re familiar with the guidelines, but you are delaying your instrument purchase (you know who you are – again, we’re not judging), we can help with that! Choosing the right instrument for your application needs can be stressful, but we’ve created a basic primer and laboratory technical guide, and a 2-part on-demand webinar series to help navigate the new guidelines and determine which elemental analysis instrument is your best fit.
Let’s say your application requires you to analyze the Class 1 impurities (As, Cd, Hg and Pb) and a few of the Class 2 and Class 3 impurities in an oral drug that dissolves easily in water or an organic solvent. It’s likely that an ICP-OES instrument will meet all your application needs.
Let’s say your application requires you to determine Class 1 impurities in a parenteral drug that requires closed vessel microwave digestion to get the sample into solution. The concentrations of the impurities in your prepared sample may now be low enough that you require a single quadrupole ICP-MS to complete your analysis.
What if you have a particularly challenging application such as determining trace levels of As in Vitamin B? The significant presence of Co in Vitamin B12 will produce an interference on As that requires the interference removal power of a triple quadrupole ICP-MS.
Like what you are learning?
A triple WHAT NOW?
Triple quadrupole ICP-MS! Still don’t know what I’m talking about? Here, this video should help:
If you’ve made an instrument purchase (or even if you haven’t) and you’re thinking, “So I’ve heard of these new guidelines, but how do I prepare and analyze MY samples?” you’re in luck. We’ve got a hands-on workshop to help guide you. Bring your samples with you, spend 2 days in our lab digesting and analyzing them, and walk away with USP-compliant results.
We’re here to help you make the transition to be compliant with the new USP guidelines, but don’t wait until December 31, 2017. Start brushing up now! Let us know how we can help in the comments!
- Elemental impurities learning center (link to thermofisher.com/LearnUSP232 )
- Application Note: Determining elemental impurities in pharmaceutical products by ICP-OES
- Application Note: Determining elemental impurities in pharmaceutical products by single quadrupole ICP-MS
- Application Note: Determination of elemental impurities in Vitamin B12 by triple quadrupole ICP-MS
- Blog post on USP <232> and ICH Q3D