Open stability testing also known as in use stability testing is designed to mimic the effects of normal use. Normal use can include but is not limited to Freeze/Thaw Cycles, Reconstitution and/or Aliquot Size. This type of study helps manufacturers understand and give guidance to end users of the product. Typically open in-use stability studies are measured using industry standard reproducibility measurements such as precision and %CV All Stability studies performed at Rockland may include customized reports generated by Rockland or using a client defined reporting template.
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Other Names
In-use Stability, Open product shelf-life, Product Use Study,