Quantification of the expected shelf-life of certified reference materials

Abstract

Stability testing and -monitoring are of the highest importance for the certification of reference materials. However, in general the results of these measurements are only assessed in a qualitative way, and no effort is made to quantify the period of certification or the shelf-life of the CRM. However, the revised ISO Guide 31 “Contents of Certificates, Certification Reports and Labels of Reference Materials” will most probably contain the explicite obligation to mention an expiry date “for all CRMs where instability has been demonstrated or is considered possible”. Therefore a method is proposed for quantifying the expected shelf-life on the basis of linear regression and determination of the intersection of the lower confidence limit of the certified value with the 95% lower confidence bound of the mean degradation curve.