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OOS Investigations

 

 

We are all too familiar with marketed processes drifting out of control and leading to out of specification (OOS) results for key physiochemical characteristics such as particle size or surface area. The fastest way to identify the root cause of these results is a thorough understanding of the process including but not limited to:  particle attributes and propensity for breakage, solubility profiles, growth and nucleation mechanisms.  At Crystal Pharmatech, we have a strong background in crystallization and particle characteristic understanding.  We will work with you to quickly and effectively identify the root cause for your OOS results then help guide you to getting your process back under control.


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  HIGHLIGHTS  

  Salt/Polymorph/Co-crystal Screening
Chiral Resolution Screening
API Form Selection and Optimization
Solid State NMR Service

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