Initial Setup
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Initial Setup

When you start an oligo analysis, all project parameters are copied into the result set. Within the oligo analysis, you only edit parameters in the result set. Project settings remain unchanged.

In this step, you confirm the project parameters and sample parameters. You ensure that the result set uses the correct compound and ion list.

Complete the Sample Information values

  1. Under Sample Information, click the Formulation field and select the appropriate values for your samples.

  2. Check the other values under Sample Information.

    If any value needs to be changed, see Prepare the result set.

    • MS condition: Indication of standard (S) or harsh (H) source conditions

    • Lot number: Batch or lot number of the sample or samples being tested

    • Formulation: Used to select acceptance criteria for each sample

    • Sample amount (mg or mL): Amount that was used for the sample preparation (weight in mg in case of DP gravimetric or DS assay, or volume in mL in case of DP volumetric assay)

    • Sample prep. volume (mL): Volume in mL, of water added to each drug

    • Label claim (mg/mL): Label claim for the drug product assay in mg/mL

    • Assay low limit (mg/mL), Assay high limit (mg/mL): Drug substance concentration lower limit and upper limit, in mg/mL

    • Moisture results (%): Results from a Karl Fischer Titration (determination of water content) in %

    • Preparation factor (Volumetric or Gravimetric)

    • Density (mg/mL): Density in mg/mL of the tested drug substance

Check the values in other sections

To be able to edit values in the other sections, you need the role Oligo Admin in addition, or the privileges that are by default included in this role. See Prepare Users.

  1. Check and update the Result Set Information values.

  2. Check and update the Compound & Impurities values.

    Ensure that an ion list is available, and the compound name is correct. The compound name must match exactly the one configured in the processing method and the one provided for your full-length product name in the ion list.

    NOTE

    If an ion list is already uploaded, and you need to exchange it: Ensure that the file with new ion list has a different filename. A file with the same filename as the already uploaded one may not be recognized as different by the browser.

    Check the setting for the latest eluting impurity. This ion that will be used as latest eluting impurity for the calculations in the System Suitability step. By default, it is detected automatically. If necessary, choose a specific ion. The drop-down list shows all names of type Ion from the ion list.

  3. Check and update the System Suitability Criteria values.

  4. Check and update the Ion Classification values.

  5. Check and update the Reference Standard values.

  6. Check and update the Acceptance Criteria values.

Confirm and proceed

  1. Click Next. This will save your changes.

  2. Confirm that you finished the current step. You will not be able to return to this step.

    Proceed with System Suitability.

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