Estimating the uncertainty of stability for matrix CRMs.
The new version of ISO Guide 34 requires producers of certified reference materials (CRMs) to include contributions of possible instability to the overall CRM uncertainty, to obtain a value for the uncertainty in compliance with the Guide to the Expression of the Uncertainty in Measurement (GUM). A pragmatic approach to estimating the uncertainty of stability is presented. It relies on regression analysis of stability data with subsequent testing of the slope of the regression line for significance. If the slope is found to be statistically insignificant, a shelf life is chosen and the uncertainty connected with this time is estimated via the standard deviation of the slope. This uncertainty is included in the overall uncertainty of the CRM. This approach is explained with examples showing its applicability to matrix CRMs.
Linsinger
T P
TP
European Commission, Joint Research Centre, Institute for Reference Materials and Measurements, Geel, Belgium.
Pauwels
J
J
Lamberty
A
A
Schimmel
H G
HG
van der Veen
A M
AM
Siekmann
L
L
D002623:Chemistry Techniques, Analytical / Q000592:standards*; D004355:Drug Stability; D006801:Humans; D006854:Hydrocortisone / Q000097:blood; D011336:Probability; D012015:Reference Standards; D015203:Reproducibility of Results; D012710:Serum Albumin, Bovine / Q000737:chemistry; D005723:gamma-Glutamyltransferase / Q000737:chemistry
D012710:Serum Albumin, Bovine; D005723:gamma-Glutamyltransferase; D006854:Hydrocortisone