Purpose

Monitoring the accuracy of measurement results and certification of measurement procedures for the mass fraction of osimertinib mesylate in osimertinib mesylate substance, pharmaceutical preparations, and materials containing osimertinib mesylate.

The reference material can be used for:

• Establishing and monitoring the stability of the calibration characteristic, provided the metrological characteristics of the reference material meet the requirements of the measurement procedure;
• Calibration of measuring instruments, provided the metrological characteristics of the reference material meet the requirements of the calibration procedure.