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Stability Testing, Shelf Life and Product Expiration Dating

Published online by Cambridge University Press:  14 March 2018

Peter A. Takes
Peter A. Takes*
Affiliation:
Sterotaxis, Inc.

Extract

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Reagents available for laboratory, research, and clinical use are often acquired with a specified expiration date. Yet, many are not, depending on the manufacturer and reagent type. What a manufacturer does is frequency determined by how they label the product.

The U.S. Ricd and Drug Administration [FDA] has defined categories by which reagents can he labeled based on their “intended use”. individual reagents (e.g., antibodies) intended for clinical diagnostic laboratory use will be labeled as an in Vitro Diagnostic [IVD] or Analyte Specific Reagent [ASR]. Under these categories, specified expiration dates must be supported by stability testing which establishes the product shelf life.

Type
Research Article
Information
Microscopy Today , Volume 6 , Issue 10 , December 1998 , pp. 20 - 21
Copyright
Copyright © Microscopy Society of America 1998

References

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