Background Image
Table of Contents Table of Contents
Previous Page  29 / 116 Next Page
Information
Show Menu
Previous Page 29 / 116 Next Page
Page Background

CHON-002

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.