Peptides MEX / Glossary
Reconstitution: presentation changes and documentation
Changing a sample’s state also changes the questions its documentation needs to answer.
Updated · Sources and editorial standards
Reconstitution differs from dilution
Reconstitution describes preparing a liquid formulation from dry material using a specified liquid. Dilution reduces the concentration of an already prepared mixture. Lyophilization names a drying process rather than a sterility test.
What changes in the documentation
Conditions for dry material do not automatically establish conditions for reconstituted material. A record should identify sample state, composition and conditions supported by the corresponding documentation. This distinction helps interpret a listing without turning it into a preparation procedure.
Questions about this reference
Sources and original reading
- FDA: Aseptic Processing of Biological Products — Post-Reconstitution and Post-Dilution Storage
- FDA: Lyophilization of Parenterals
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