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White Paper:

Ensuring Consistency in Polymorphic Drug Substances and Products

 

To ensure the quality of pharmaceutical products, manufacturers must characterise and quantify their physical nature throughout all phases of development, beginning with the drug substance, or Active Pharmaceutical Ingredients (API), and over the product’s entire shelf life.

Whitepaper key topics: 

  • Ensuring Consistency
  • When and how to apply a specification limit
  • Manufacturing and Transformation of forms
  • Regulatory requirements
  • Establishing and monitoring the presence of Polymorphs
  • How X-Ray powder diffraction works

Submit the form on this page to access the Whitepaper or if you have a specific query regarding Solid State Services you can contact us directly. 

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  • Dr Edislav Leksic, Almac Physical Sciences Team Leader, presents a webinar on Limit Test: Ensuring Consistency in Polymorphic Drug Substances & Products. 









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