Unveiling the mysteries of acetaminophen polymorphs with advanced Raman spectroscopy
When was the last time you reviewed or optimized your API characterization processes?
Process development scientists in the pharmaceutical industry are often fearful of changing established workflows, because API production carries significant risks involving purity, safety and time. Consequently, pharmaceutical companies often stick with trusted methods – after all, nobody wants to be held accountable for a change that disrupts operations.
Better processes = better results
As a result, solid-form analysis processes tend to stay the same for years. But every process can always be better. And while processes remain stagnant, technology and methodologies evolve, creating a widening gap between how efficient a workflow is and how efficient it could be.
With the right technology, implemented in the right way, there’s no reason to fear change. In our new application note we show you how incorporating Morphologically-Directed Raman Spectroscopy (MDRS) can deliver a new level of precision in solid-state analysis, helping to minimize production risks – often in ways you might not have realized.
Five reasons to download this application note:
An essential read for anyone involved in the development and quality assurance of active pharmaceutical substances, this application note details how MDRS can be utilized to discern between polymorphic forms, ensuring the correct form is used for maximum efficacy and safety. Download it today to access technical insights from our analytical experts:
- Explore MDRS: Discover a detailed account of how automated microscopy combined with Raman spectroscopy can be used to analyze and distinguish between polymorphs of acetaminophen. See how MDRS can also quantify the presence of different polymorphs, which is crucial for quality control and formulation stability.
- Practical insights: Learn about the methodologies employed in this study, including sample preparation, the specifics of particle size and shape analysis, and the details of Raman spectral analysis. This is complemented by real data that illustrates the practical application of this method.
- Advanced analytical capabilities: Find out how MDRS offers a significant improvement in efficiency and sensitivity over other solid-state characterization methods.
- Implications for API development and quality control: Understanding the polymorphic forms of a drug substance is critical for ensuring its stability and efficacy. Learn how MDRS aids in this process, making it invaluable for those involved in API development, formulation development and quality assurance.
- Statistical Data: Equipped with figures and statistical data, the application note provides a clear visual understanding of the distribution and characteristics of polymorphic particles. This data is crucial for making informed decisions during all stages of drug development .
If you want to optimize your approach to drug substance analysis and quality control it’s time to discover how MDRS can enhance your analytical capabilities.