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Chemical Purity Analysis

Analysis for impurities and degradants is fundamental to any early development effort. Understanding the chemical profile of your drug substance can open the door to a stable, bioavailable formulation that will successfully carry your project through clinical trials and on to market. Patheon has a broad range of capabilities to help you quickly understand these properties and deliver better outcomes.

Patheon uses HPLC, UPLC and PDA analysis to develop, implement and conduct analytical methods for your samples. These methods are scientifically evaluated to separate your main component from other known and potential impurities and degradants – and thus determine chemical purity.

Patheon seamlessly integrates chemical purity analysis into a complete early development program driven by an experienced dedicated team. This makes Patheon the most rapid and cost-effective way to go from molecule to market.

Case Study: Exploring the Limits of Chemical Purity Analysis

The Challenge Patheon conducted a study to challenge the claim that a PDA detector has the capability of detecting co-eluting components in HPLC peaks since this is based on UV spectroscopy, which is relatively nonspecific.

The Solution Component pairs of compounds with 1) almost identical, 2) very similar and 3) similar UV spectra were tested using HPLC methods that did not separate them. Applying the PDA algorithm, co-elution was not detected even with 10% impurity in case 1) but was detected with just 0.5% and 0.2% levels in cases 2) and 3) respectively.

The Outcome This analysis verified that PDA was effective for this type of study provided there were at least some spectral differences.

Ask The Experts

Geoff Carr, Ph.D.

Geoff Carr, Ph.D.
Dr. Carr offers Patheon customers 36 years of applying analytical science to the creation of pharmac
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William E. Weiser, Ph.D.

William E. Weiser, Ph.D.
Dr. Weiser is an expert in analytical method development and validation for APIs and drug products.
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