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Determine elemental impurities with confidence

Worldwide regulatory agencies have the responsibility to ensure the safety and effectiveness of pharmaceutical products. To meet this obligation, all potentially toxic and harmful contaminants, including elemental impurities, must be monitored to ensure compliance with the maximum allowable concentrations. This is addressed by agencies such as the United States Pharmacopeia (USP), the International Council for Harmonization of Technical Requirements (ICH), and the European, Chinese, and Japanese Pharmacopoeias (Ph. Eur., CHP, and JP).These various bodies have come together to create comprehensive elemental impurity standards, which are defined in ICH guideline Q3D(R2) (1) and USP National Formulary (NF) chapter (2). The latest ICH and USP methods specify 24 elements to be monitored that have a permitted daily exposure (PDE) in μg/day assigned based on the methods provided by USP and ICH. Agilent offers complete workflows for confident elemental impurities testing.

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USP methods from sample preparation to report generation

Complete workflows to reliably address regulatory requirements for elemental impurities analysis

USP 232/233 Elemental Impurities Analysis

In this 3-part webinar series, learn about USP methods and FDA requirements for elemental impurities analysis, and explore tools to facilitate compliance.

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Improving efficiency with ICP-OES and ICP-MS

Learn tips to improve efficiency without sacrificing quality. Explore AI-based software tools to simplify method development and reduce errors.

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Join the Agilent Community. Ask, Answer, and Collaborate

A place you can go with questions or for advice about your instruments or methods. Get expert information when you need it.

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ICP-OES vs ICP-MS for elemental impurities analysis

How do you choose the right instrument for your lab?  When comparing the two techniques it’s important to realize that there is an overlap of the concentration ranges that ICP-OES and ICP-MS can measure. If all elements are consistently at concentrations above 10 ppb then ICP-OES is the best option. If you need to measure lower concentrations of some elements or you need to measure C, F, Cl, Br, or I then elemental analysis by ICP-MS is recommended. Even with ICP-MS, detection limits for C are poor, and F requires a specialized ICP-QQQ approach.  Find resources to help you make the right choice for your analysis.




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Elemental analysis using ICP-MS

Elemental analysis using ICP-OES

Compliance enablement

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