Reconstituted
Rehydrate freeze-dried (lyophilized) product with sterile diluent.
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Lyophilized
Freeze-dried. A manufacturing process where water is removed from a product in a controlled environment. The resulting product is a dry, flaky material of high stability (i.e. its shelf life is much longer than aqueous products). Prior to use, the lyophilized product must be
Reconstituted
(re-hydrated) with an appropriate sterile diluent. read moreEffect of Formulation on Stability
Effect of Formulation on Stability Below is a figure that shows how expiration dating varies by formulation. For standardized products, these dates were established through FDA-approved testing methods. For non-standardized products, these dates were established by the FDA. For more information on extract formulation, please see the section on Extract Formulations Expiration dates for bulk…
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Extract Formulations
Extract Formulations Allergen extracts are available in a variety of formulations. An extract’s formulation directly impacts the stability of the allergenic proteins in solution and therefore the shelf life of the product. The FDA has determined maximum expiration dates for each formulation based on the estimated loss of potency over time. All extracts can be…
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