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Reconstitution Protocol

Meaning

A Reconstitution Protocol is a precise, sterile, and standardized set of instructions detailing the necessary steps for dissolving a lyophilized, or freeze-dried, pharmaceutical substance, often a peptide or protein hormone, into a sterile liquid solvent, typically bacteriostatic water. This procedure is critical in clinical practice to ensure the final solution is accurately concentrated, chemically stable, and biologically active for subcutaneous or intramuscular administration. Adherence to the protocol minimizes the risk of denaturation or microbial contamination of the therapeutic agent.