Categories - 3) Premier Standard
3) Premier Standard
Documentation and Compound characterization as Premier Standard
is the most extensive version with the highest quality. The
Premier Standards are completely documented Primary Standards
(see above) in the RMF Format with the actually worldwide greatest
complete Validation.
This "Supplement Validation to RMF" contains following
further analytical data:
- Definition of 2 selective and independent analytical methods
- Measurement of the precision of this 2 independent methods
(6 x test)
- Linearity of both methods in the range of
50 – 150%
- Determination of detection limit and limit of
quantitation of both methods
- Determination of the robustness of both methods by variation
of 2 parameters
- Examination of the stability of the
used solutions
- Determination of the precision of the instruments (both
methods 8 x test)
- Test for intermediate precision (both methods 8 x test
with compatible analytical systems)
- Statistical comparison of the measured data with F– and T–Tests
and documented as graphics.
- Finally determination of the "Right
Content" according the institutional
requirements.