Advanced Quantitation in Empower Webinar – Summary

In the previous webinar, “Quantitation in Empower 3”, we discussed about how Empower
converts chromatographic peaks into numerical amounts. Briefly, the Standard chromatograms
are integrated and calibrated, allowing us to build a calibration curve. The Sample
chromatograms are then integrated, and its area quantitated against the calibration curve.

To plot a calibration curve, the Amount of the Standards (𝐴𝑚𝑜𝑢𝑛𝑡𝑆𝑡𝑑 ) come from formula .
With the Peak Area and corresponding Amount of Standards, we can plot the points for our
Standards on the Calibration Plot, and subsequently, the Calibration Curve.

When the Sample is injected, the Peak Area in the Sample is compared to the Calibration Curve
and the Value of Sample (𝑉𝑎𝑙𝑢𝑒𝑆𝑝𝑙 ) is obtained. The final Sample Amount (𝐴𝑚𝑜𝑢𝑛𝑡𝑆𝑝𝑙 ), is

calculated by Empower through formula .

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In the previous webinar, we have covered how we can make use of Purity via Component
Editor, or Sample Weight and Dilution via Sample Set Table, to streamline quantitation.

In this webinar, we will look into how we can automate the quantitation further, by having the
Value of the Standard and Sample Weight of the sample input through the Sample Weight
Importer.

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 1. Sample Weight Importer: Import Standard and Sample Weights from
Weighing Balance
The Sample Weight Importer (SWI) offers:

For Samples, weight can be transferred easily from the Sample Weight Importer to the Sample
Set Table’s Sample Weight column.

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For the Standards, the weights are transferred from the Sample Weight Importer to the
Component Editor.

The paperless transfer of sample weights eliminates transcription error. This not only
streamlines the workflow, it also greatly reduces data integrity risks that comes with manual
processes.

Data compliance is greatly enhanced as well. Empower Audit Trail tracks all the sample weight
and value imports from Sample Weight Importer, allowing users to not only track the weight
imported, but also determine who weighed the samples, which weighing balance was used and
when the weighing was done. The use of SWI also ensures that the first reading on the
weighing balance is captured, satisfying the need for originality in ALCOA+.

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2. Custom Fields: For Advanced Assay Calculations
Empower allows you to perform advanced calculations through custom fields. Custom Fields
are identical to predefined fields and can be used fully in all operations in Empower. There are
two main categories of custom fields: Descriptors and Calculations.

In this illustration, a calculation that is commonly used in the Pharmaceutical industry was used.
𝑨𝒎𝒐𝒖𝒏𝒕
𝑨𝒔𝒔𝒂𝒚, 𝒐𝒏 𝒂𝒏𝒉𝒚𝒅𝒓𝒐𝒖𝒔 𝒃𝒂𝒔𝒊𝒔 = × 𝟏𝟎𝟎
(𝟏𝟎𝟎 − %𝑳𝑶𝑫)

Where,
𝐴𝑚𝑜𝑢𝑛𝑡 = Amount calculated from Empower = 123.5 mg
%𝐿𝑂𝐷 = Percent Loss on Drying = 0.24 %

A custom field, AssayCorrected_LOD was created for this calculation. The custom field formula
is seen on the left. On the right, a manual calculation is performed for this formula, obtaining a
calculated Assay, on anhydrous basis value of 123.848 mg.

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Empower can calculate the custom field automatically upon processing. However, Empower
obtained a value of 123.849 mg while manual calculations obtained a value of 123.848 mg. It
was found that transcribing 3 decimal places is insufficient and transcribing 5 decimal places is
required to avoid a rounding error.

Setting up custom fields is a one-time effort, much like setting up the calculations in your Excel
spreadsheet. Using custom fields can help to:

• Eliminates transcription errors and saves time: Manual transcription of data from multiple
sources used for calculation increases risk of human error and subsequent lengthy
laboratory investigation and CAPA.
• Swift decision making: On top of generating calculations, Empower can also generate
pass or fail reports using Boolean custom fields based on user-set criteria. The
generation of a pass/fail result eliminates misinterpretation and are fully automated. This
enables decisions to be made swiftly, enhancing productivity.

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 • Traceability between reported results and calculations: Since all the results are
generated within a single software, it is easy to trace the final results back to the raw
data.

By using custom fields for calculations, we ensure that the data is accurate and attributable,
satisfying ALCOA+ requirements.

3. Batch Processing
To do batch processing,

A result set is generated. The user can click on Review to review the results or Publisher for
result reporting.

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Performing batch processing:

• Efficient, effective processing of raw data: Process with a simple click of the button. All
Empower and custom fields calculations are generated with batch processing.

• Ensures the completeness of the data: The user cannot skip over individual injections
and must process everything. Ensuring that data processed is complete satisfies
ALCOA+ requirements.

• Ensures consistency in data processing: Processing using the processing method allows
all standards and samples to be processed with the same parameters. Subsequently,
manual integration may be required but it should not be the first option. Each time a user
manual processes the results, there is a potential for mistakes or deliberate data
manipulation.

Stay tuned for our next webinar and learn how you can streamline your workflow (with specific
examples for the food industry) with:

• Interactive System Suitability

For more Empower tips, please visit Empower Tip Of The Week blog at:
https://waters.com/empowertips

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