Designing Freeze-Thaw Protocols for Parenteral Formulations
Designing Freeze-Thaw Protocols for Parenteral Formulations Designing Robust Freeze-Thaw Protocols for Parenteral Formulations: A Scientific and Regulatory Approach Parenteral formulations—injectable drugs administered intravenously, subcutaneously, or intramuscularly—are highly sensitive to temperature excursions. Exposure to freeze-thaw cycles during transport, storage, or distribution can compromise their physical, chemical, and microbiological stability. As regulatory expectations grow, well-designed freeze-thaw protocols…
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