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Characterization of Non-Compendial Impurity Reference Standards –
How Good Is Good Enough?

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Overview

Characterization of non-compendial impurity reference standards – How Good Is Good Enough

Identification and quantification of impurities in pharmaceuticals is critical throughout drug development and manufacture to ensure product quality. There are significant risks when using a qualitative certified reference standard for a quantitative analysis. Learn how the characterization of reference standards can dramatically reduce the risk of out of specification investigations, lengthy toxicity studies, and even the loss of entire batches.

Key Learning Objective

  • Explore different approaches to using non-compendial reference standards.
  • Learn how reference standards are characterized.
  • Learn the difference between a qualitative and quantitative reference standard.
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LGC Mikromol

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