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Wednesday, February 5, 2020International

Validation method for quantitative analytical methods: New ISO standard

ISO/TS 22176:2020

The ISO/TS 22176:2020 standard, for the cosmetics industry, propose a characterization protocol for the validation of a quantitative analysis method in the cosmetic field. This text became effective at the end of January 2020.

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Analytical methods for analyses of cosmetics need to be validated.
Validation has been long considered as a process consisting in individually verifying several different criteria, i.e. selectivity, repeatability, linearity, trueness, etc.
The large number of cosmetic products and the variety of matrices present a challenge for an analytical laboratory requiring that standardized methods to be adapted for each type of samples.
Additional difficulties are linked to the very low concentrations to be measured, generally of the order of the mg/kg (ppm) or µg/kg (ppb).
In such context, criteria such as accuracy and uncertainty of measurement of the analytical results are of utmost importance.

“This document defines a global approach for the validation of a quantitative analytical method, based on the construction and interpretation of an accuracy profile, and specifies its characterization procedure. This procedure is particularly applicable for internal validation in a cosmetic testing laboratory, but its scope can be extended to the interpretation of data collected for an interlaboratory study designed according to the recommendations of the ISO 5725-1,” explains ISO (International Organization for Standardization). “It does not apply to microbiological trials. The present approach is particularly suited to handle the wide diversity of matrices in cosmetics. This document …

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