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tablet used. Inter-day Precision was reported at 1.94% RSD
and Intra-day precision was reported at 1.53%, which meets
the SMPR of less than or equal to 2%.
Reproducibility (RSDR)
Assessed using the combined %RSD of the analysis of two
samples over two days. This was done within the same
laboratory rather than a multi-laboratory validation as stated
in the SMPR.
System Suitability
No system suitability results were reported for the validation
nor are there any stated requirements in the method to
ensure the system is operating as intended prior to analysis.
Is the method safe to use as
written?
Yes
Are there any safety concerns
with any component,
instrument, reagent or
instruction of the method? If
yes, please clearly state the
concerns.
No
Does the method include all
necessary safety precautions
and/or warning statements? Yes
or No. If No, please suggest
potential precautions or
warnings that can be added to
the method for users or
recommend safer option(s) if
warranted.
There is no mention of any safety precautions in the method.
Recommendations
Final Recommendation:
I do not recommend the method be adopted for First Action
status. The method uses instrumentation that is not widely
used in commercial testing laboratories. The methodology
lacks specificity and robustness. There are far too many
parameters that require strict controls thus making this
method undesirable for routine QC testing.