And the Most Popular Question About Probiotics Is…?

Customers often ask us if probiotics are shelf stable and our answer is always the same; only testing can determine the shelf stability of a particular probiotic product. While the ingredient manufacturer should have data on their products, once you blend the raw material with other ingredients, then stability needs to be confirmed.

Stability testing is required when an expiration date is listed on the product label. The International Council for Harmonization (ICH) has guidelines for various storage conditions to use when trying to prove stability or the shelf life of a product. Many products can simply be held a few months at accelerated heat and humidity conditions to prove product stability for the future expiration date. However, specialty ingredients, like probiotics and enzymes, are more sensitive to these extreme conditions and will show a more rapid decline than if they were just stored on a shelf in ambient conditions. For these products, the data from the accelerated study may not be accurate.

One way is to label the first batch of probiotics or enzymes with a manufacturer’s date and then run the ambient 25˚C/60% RH real-time stability study over the years needed to prove the shelf life. This allows future batches to list an accurate expiration date.

But it’s important to note that many factors can affect meeting label claims of these specialty products. Moisture, heat, pH, product handling, storage and co-ingredients in the blend can all be detrimental to full recovery of the active ingredients. It takes testing during the product development stages to determine what active ingredients can be tested successfully. Then when the product is finally manufactured the stability testing can be established and monitored throughout the shelf life.

SORA Labs is here to help! We offer on-site, stability storage in real-time conditions of 25ᵒC ±2 /60% RH ±5 and can quote other conditions that may be needed. Let us quote your next stability project!

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