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Non-Sterile Reconstitution

Meaning

Non-sterile reconstitution is the pharmaceutical process of adding a solvent, such as purified water or a specific diluent, to a powdered or lyophilized drug product outside of a strictly controlled, aseptic environment to prepare a solution or suspension for administration. This procedure is typically reserved for compounded preparations intended for non-parenteral routes, such such as oral, rectal, or topical application, where the risk of microbial contamination is mitigated by the route of administration. It contrasts sharply with sterile compounding, which demands rigorous environmental controls to prevent microbial ingress.