Stability and Shelf Life Testing

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Stability Testing and Expiration Dating

Expiration dating is often defined as determining the time interval during which a product is known to remain stable when stored under recommended conditions. Manufacturers provide expiration dates to help consumers identify products that may no longer be “good”. Expiration dating is not currently required by federal law for most food products and dietary supplements. Certain industry standards and retailers, however, do require it.

Stability testing can be used not only to establish an expiration date but also to ensure that label claims are met throughout a product’s shelf life. It involves monitoring the product as packaged under recommended storage conditions over a period of time, with periodic testing to see that the product meets specifications. These specifications may include physical properties, chemical composition, and biological characteristics.

Elevated temperature and humidity studies can be used to predict stability and may be the only option for new products since real time data does not yet exist. Note that expiration dates must be confirmed on the basis of “real time studies” on products stored under labeled storage conditions. According to FDA, the use of accelerated testing data to establish a very long expiration dating period (greater than 3 years) is not recommended.

Choosing the appropriate specifications for testing of certain food products and dietary supplements is critical to ensuring the reliability of the testing data. Information on the identity and relevance of certain ingredients and compounds to the product’s activity can greatly assist in defining the most appropriate methods and parameters. Eurofins Scientific can help design your stability study and choose the most defensible specifications to monitor.

For your stability study, we use chambers that comply with industry accepted standards. These chambers are maintained at:

25C / 60% RH - ambient
40C / 75% RH - accelerated

Additional chambers are available for non-standard temperatures and humidity conditions.

Eurofins Scientific, Inc.

3507 Delaware

Des Moines, IA 50313

Phone: (515) 265-1461

Fax: (515) 266-5453

Account Name: Account Number: Bank Name: Address: Attention: ABA Routing Number: Special Instructions:	Eurofins GeneScan Relief Fund 8021123424 Regions Bank 6200 Poplar Avenue Memphis, TN 38119 Donald Hunt 062005690 Contact Donald Hunt at (901) 580-5428 when received.
Checks can be mailed to: Special Instructions:	Regions Bank Attention: Donald Hunt 6200 Poplar Avenue Memphis, TN 38119 Please indicate on the check "Eurofins GeneScan Relief Fund".