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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
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Almac API, Chemical Development, Analytical & Solid State Services

Almac Sciences provides integrated services from development to commercial scale of advanced intermediates and Active Pharmaceutical Ingredients (API).

We provide a range of services for small molecules (including highly potent) and peptides. We have a proven track record of saving time and cost through the integration of our services and application of innovative biocatalysis and technology solutions.

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We offer a full suite of analytical testing for a range of different product types including small molecules, peptides, biologics, conjugates, potent and controlled substances.

Our vast pool of scientific knowledge can help to overcome the analytical challenges that typically arise during drug development.

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