Residual Moisture Detection in Lyophilized Products

Karl Fischer Titration for Residual Moisture

Lyophilization, also known as freeze-drying, is a process of removing water from a parenteral formulation to increase product stability and shelf life. Most biologics require a certain range of moisture, even in a lyophilized state, to maintain bioactivity, ease of reconstitution, and to give a good cake appearance. Measuring the residual moisture content of a …

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Thermal Characterization for Cycles

Why is thermal characterization used? Why is it used to to optimize lyophilization cycles? View this detailed video lecture by Dr. Jeff Schwegman on the use of thermal characterization in lyophilization cycle development and optimization:

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What is Thermal Characterization?

Freeze dry microscopy collapse image critical temperature

Thermal Characterization Background At AB BioTechnologies, development of optimized lyophilization cycles as well as formulation development for lyophilized products begins with thermal characterization and on an as-needed basis. Thermal characterization consists of two separate tests: differential scanning calorimetry and freeze-dry microscopy. Differential Scanning Calorimetry (DSC) Differential scanning calorimetry (also known as DSC) is not unique to …

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