3
Figure 1
.
Note: The following two days analysis need to be performed on
consecutive days
.
Read and become familiar with the Protocol and Method.
Make sure all health and safety procedures are understood
and any specific laboratory requirements are fulfilled.
Source all chemicals and reagents required for the method.
Set up HPLC system and install column as per method
Prepare solutions, mobile phases and Stock Reference
Calibration Standard
Perform instrument specific system suitability checks.
Prepare the Practice samples with
a
freshly diluted 6
point
calibration curve.
Set up sequence and run The sample set
Complete the results template and submit to the study director for
review. Let the SD know of any issues with sample preparation or
analysis
Following approval of the practice samples, prepare and run
the collaborative test samples with a
freshly prepared 6
point calibration curve. Include System Suitability checks and
include the practice samples as control samples.
Check results for “correctable outliers” and send the complete set
of results to the SD. Include system check data.
Flow Diagram of the proposed work required for the collaborative trial.
Day 1
Day 2
Day 3
Day 5
Review Analytical run from Day 3. Prepare and run the
collaborative test samples with a
freshly diluted
6 point
calibration curve. Include System Suitability checks and
include the practice samples as control samples.
Day 4
Vitamin A & E MLT Protocol
For ERP Use Only
DO NOT DISTRIBUTE
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