Whitepaper
Importance of Assessing Mannitol Crystallinity in Lyophilized Drug Products
Resource Overview
Mannitol is a versatile excipient used in freeze-dried injectables in the pharmaceutical industry. Depending on the freezing and/or annealing conditions employed, mannitol is retained either as amorphous or crystalline. Crystalline mannitol is more prevalent in drug product formulations than amorphous mannitol. When crystalline, it provides an opportunity to conduct lyophilization cycles at aggressive conditions due to its high eutectic melting point (about – 1.5°C). The resultant freeze-dried solids are pharmaceutically elegant in appearance with cake uniformity.
In this whitepaper learn more from the Simtra BioPharma Solutions team on the Importance of Assessing Mannitol Crystallinity in Lyophilized Drug Products.
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