Ensuring Consistency in Polymorphic Drug Substances and Products
To ensure the quality of pharmaceutical products, manufacturers must characterize 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
