https://www.selleckchem.com/products/kp-457.html
Freeze-drying, also known as lyophilization, is a dehydration process designed to prolong the shelf life of injectable drug products. Here, we provide regulatory considerations for manufacturing processes specific to lyophilized injectable products. Specifically, a general discussion on each unit operation, including compounding, filtration, filling, and lyophilization, is provided to help the pharmaceutical industry establish reliable manufacturing processes from a regulatory perspective. In addition, a list of manufacturing-related def
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