A–D

Find reference information on document elements of the Microbial Assays for Antibiotics Package, letters A to D.

Activated

Select the Deactivated option from the drop-down list to disable Replicate averaging.

This element has the following attributes:

Data type Multiplicity Usage Default value
Empty 1...1 required none

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Replicate averaging/choice/

Adjustment

Adjust your response values by Fixed value or by Assay element. The processing step applies for all assay elements.

Expand the node to add or view information.

Example: Use this feature to subtract the absorbance of blank wells.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...unbounded optional none

Context:

/Cylinder-plate assay (JP 4.02)/Analysis/Response data processing/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Response data processing/choice/

Adjustment

Adjust your response values by Fixed value or by Assay element.

Expand the node to add or view information.

Example: Use this feature to subtract the absorbance of blank wells.

Tip: Add a scope element from the Creatable elements pane if you require.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...unbounded optional none

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/

Allow subfolders

Note: The Allow subfolder setting only applies if you also specify a folder in the Folder key element.

Select the 'true' option from the drop-down list to require referenced documents be elements of the specified folder or one of its subfolders. Otherwise, subfolders are excluded.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:boolean 0...1 optional none

Context:

/Combination of microbial assays/Potency data/Column: Document reference/

Amount

Enter the amount of the substance.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:token 0...1 optional none

Context:

/Combination of microbial assays/Documentation/Reagent/

/Cylinder-plate assay (JP 4.02)/Documentation/Reagent/

/Cylinder-plate assay (USP <81>)/Documentation/Reagent/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Reagent/

Analysis

This section allows you to select the Logarithm base (binary, decimal, or natural logarithm), specify the Confidence level (%), and enable outlier testing to be used in combination calculations.

Expand the node to add or view information.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Combination of microbial assays/

Analysis

This section allows you to specify the Response data processing steps (adjustments, normalizations, transformation, replicate averaging) and the Suitability tests (statistical tests) to be used in calculations. It also provides options for dose transformation. Expand the node to add or view information.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/

Analysis

This section allows you to specify the Response data processing steps (adjustments, normalizations, transformation) and the Suitability tests (statistical tests) to be used in calculations. It also provides options for dose transformation and sample correction methods. Expand the node to add or view information.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Cylinder-plate assay (USP <81>)/

Analysis

This section allows you to specify the Response data processing steps (adjustments, normalizations) and the Suitability tests (statistical tests) to be used in calculations. Expand the node to add or view information.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/

Assay design

This section allows you to specify the general layout of the cylinder-plate assay (JP 4.02), that is, the number of Sets per plate, the Number of plates, and the potencies of the two Standard solutions (high and low concentration).

Expand the node to add or view information.

A set provides four observations, that is, one observation each for the:

  • Standard solution of high concentration
  • Standard solution of low concentration
  • Test sample solution of high concentration
  • Test sample solution of low concentration

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/

Assay design

This section allows you to specify the general layout of the cylinder-plate assay (USP <81>), that is, the number of Cylinders per plate, Reference measurements per plate, and Plate replicates.

Expand the node to add or view information.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Cylinder-plate assay (USP <81>)/Setup/

Assay element

Select the assay element to be used for calculating the adjustment value.

Tip: Add the Sequence step element from the Creatable elements pane if you want to use a particular sequence step of the assay element.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:string 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Analysis/Response data processing/choice/Adjustment/choice/by Assay element/

/Cylinder-plate assay (USP <81>)/Analysis/Response data processing/choice/Adjustment/choice/by Assay element/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Adjustment/choice/by Assay element/

Assay element

Select the assay element to be used for calculating the normalization factor.

Tip: Add the Sequence step element from the Creatable elements pane if you want to use a particular sequence step of the assay element.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:token 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Analysis/Response data processing/choice/Normalization/choice/by Assay element/

/Cylinder-plate assay (USP <81>)/Analysis/Response data processing/choice/Normalization/choice/by Assay element/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Normalization/choice/by Assay element/

Assay element scope

Select the assay element whose response values are to be modified during response data processing.

Tip: If you require 'Assay element type scope' or 'Rack scope', select the corresponding option from the drop-down list.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:string 0...1 optional none

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Adjustment/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Normalization/choice/

Assay element scope

Select the assay element you want to include in the test.

Tip: If you want to include an entire assay element type rather than just a particular assay element, select the 'Assay element type scope' option from the left drop-down list.
Note: The test type determines which assay elements you can select for a test. Some tests are only performed for particular types of assay elements. Please consult the help pages on particular tests for additional information.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:string 1...1 required none

Context:

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Step - Standard deviation/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Step - Relative standard deviation CV (%)/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Plate correction/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Step - Standard deviation/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Step - Relative standard deviation CV (%)/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Plate correction/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Response range/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Step - Standard deviation/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Step - Relative standard deviation CV (%)/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Response range/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Step - Standard deviation/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Step - Relative standard deviation CV (%)/choice/

Assay element scope

Select the assay element you want to include in the test.

Tip: If you want to include an entire assay element type rather than just a particular assay element, select the 'Assay element type scope' option from the left drop-down list.
Note: The test type determines which assay elements you can select for a test. Some tests are only performed for particular types of assay elements. Please consult the help pages on particular tests for additional information.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:string 1...1 required none

Context:

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Sample - Mean response/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Potency of the working sample/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Absolute potency/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Relative potency (percentage of reference concentration)/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Sample - Mean response/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Potency of the working sample/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Absolute potency/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Relative potency (percentage of reference concentration)/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Potency of the working sample/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Absolute potency/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Relative potency (percentage of reference concentration)/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Potency of the working sample/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Absolute potency/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Relative potency (percentage of reference concentration)/choice/

Assay element type scope

Select the assay element type whose response values are to be modified during response data processing.

The following options are available from the drop-down list:

  • All assay elements
  • Standard only
  • Test samples only
  • Control samples only
Tip: If you require 'Assay element scope' or 'Rack scope', select the corresponding option from the drop-down list.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:string 0...1 optional none

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Adjustment/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Normalization/choice/

Assay element type scope

Select the assay element type you want to include in the test.

The following options are available from the drop-down list:

  • All assay elements: Runs the test for every assay element.
  • Standard only: Runs the test for the Standard sample.
  • Test samples only: Runs the test for every Test sample.
Note: The test type determines which assay elements you can select for a test. Some tests are only performed for particular types of assay elements. Please consult the help pages on particular tests for additional information.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:string 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Sample mean response/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Sample response sum/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Sample response standard deviation/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Sample relative response standard deviation/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Sample mean response/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Sample response sum/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Sample response standard deviation/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Sample relative response standard deviation/

Assay element type scope

Select the assay element type you want to include in the test.

The following options are available from the drop-down list:

  • All assay elements: Runs the test for every assay element.
  • Standard only: Runs the test for the Standard sample.
  • Test samples only: Runs the test for every Test sample.
  • Control samples only: Runs the test for every Control sample.
Tip: If you just want to include a particular assay element rather than an entire assay element type, select the 'Assay element scope' option from the left drop-down list.
Note: The test type determines which assay elements you can select for a test. Some tests are only performed for particular types of assay elements. Please consult the help pages on particular tests for additional information.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:string 1...1 required none

Context:

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Step - Standard deviation/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Step - Relative standard deviation CV (%)/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Plate correction/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Step - Standard deviation/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Step - Relative standard deviation CV (%)/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Plate correction/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Response range/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Step - Standard deviation/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Step - Relative standard deviation CV (%)/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Response range/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Step - Standard deviation/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Step - Relative standard deviation CV (%)/choice/

Assay element type scope

Select the assay element type you want to include in the test.

The following options are available from the drop-down list:

  • Test samples only: Runs the test for every Test sample.
  • Control samples only: Runs the test for every Control sample.
Tip: If you just want to include a particular assay element rather than an entire assay element type, select the 'Assay element scope' option from the left drop-down list.
Note: The test type determines which assay elements you can select for a test. Some tests are only performed for particular types of assay elements. Please consult the help pages on particular tests for additional information.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:string 1...1 required none

Context:

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Sample - Mean response/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Potency of the working sample/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Absolute potency/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Relative potency (percentage of reference concentration)/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Sample - Mean response/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Potency of the working sample/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Absolute potency/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Relative potency (percentage of reference concentration)/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Potency of the working sample/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Absolute potency/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Relative potency (percentage of reference concentration)/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Potency of the working sample/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Absolute potency/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Relative potency (percentage of reference concentration)/choice/

Assay element type scope

This test is only available for the Standard sample.

Note: The test type determines which assay elements you can select for a test. Some tests are only performed for particular types of assay elements. Please consult the help pages on particular tests for additional information.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:string 1...1 required none

Context:

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Correction point/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Correction point - Standard deviation/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Correction point - Relative standard deviation CV (%)/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Parameter/property point estimate/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Assay suitability tests/choice/Test: Coefficient of determination (R²)/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Correction point/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Correction point - Standard deviation/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Correction point - Relative standard deviation CV (%)/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Parameter/property point estimate/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/Sample suitability tests/choice/Test: Coefficient of determination (R²)/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Combined standard deviation of the standard/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Parameter/property point estimate/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Coefficient of determination (R²)/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Combined standard deviation of the standard/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Parameter/property point estimate/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Coefficient of determination (R²)/

Assay element type scope

This test is only available for Test samples.

Note: The test type determines which assay elements you can select for a test. Some tests are only performed for particular types of assay elements. Please consult the help pages on particular tests for additional information.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:string 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Potency of the working sample/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Absolute potency/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Potency factor A/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Potency of the working sample/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Absolute potency/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Potency factor A/

Assay elements

This section allows you to define all assay elements.

Expand the node to add or view information.

Cylinder-plate assay (JP 4.02) documents contain two types of assay elements: The Standard sample and a single Test sample.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/

Assay elements

This section allows you to define all assay elements.

Expand the node to add or view information.

Turbidimetric assay (USP <81>, JP 4.02) documents contain three types of assay elements: The Standard sample, Test samples, and Control samples. Standard and Test samples are diluted samples. Control samples may also serve as positive, negative, or blank controls.

Add one or several of the following assay elements from the context menu or Creatable elements pane:

  • Test: To determine their relative concentrations.
  • Control: To define additional acceptance criteria.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/

Assay elements

This section allows you to define all assay elements.

Expand the node to add or view information.

Cylinder-plate assay (USP <81>) documents contain three types of assay elements: The Standard sample, Test samples, and Control samples. Standard and Test samples are diluted samples. Control samples may also serve as positive, negative, or blank controls.

Add one or several of the following assay elements from the context menu or Creatable elements pane:

  • Test: To determine their relative concentrations.
  • Control: To define additional acceptance criteria.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Cylinder-plate assay (USP <81>)/Setup/

Assay purpose

Enter text that describes the purpose of this assay.

Provide the analyte (target of the analysis), for example, and its unique identification.

Tip: You can enter multiline text.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:string 0...1 optional none

Context:

/Combination of microbial assays/Documentation/

/Cylinder-plate assay (JP 4.02)/Documentation/

/Cylinder-plate assay (USP <81>)/Documentation/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/

Assay suitability tests

Add the Assay suitability tests you require.

Important: The results of Assay suitability tests affect the whole assay rather than just the individual assay elements that are evaluated.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/

/Cylinder-plate assay (USP <81>)/Analysis/Test system/

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Test system/

Author

Automatically inserts the user name of the current user when the Author element is created. You can enter a different name.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:token 1...1 required none

Context:

/Combination of microbial assays/Comment/

/Cylinder-plate assay (JP 4.02)/Comment/

/Cylinder-plate assay (USP <81>)/Comment/

/Turbidimetric assay (USP <81>, JP 4.02)/Comment/

Base layer

This documentation section allows you to provide information on the base layer. Expand the node to add or view information.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...1 optional none

Context:

/Cylinder-plate assay (JP 4.02)/Documentation/

/Cylinder-plate assay (USP <81>)/Documentation/

by Assay element

Select an option from the 'Assay element' drop-down list below to specify the Assay element to be used for calculating the adjustment value.

Note: By default, the adjustment you select is applied to every response value. Add a scope from the Creatable elements pane to restrict its application to an Assay element type, Assay element, or Rack.
Tip: If you require 'No adjustment' or adjustment 'by Fixed value', select the corresponding option from the 'Adjustment' drop-down list.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Adjustment/choice/

by Assay element

Select an option from the 'Assay element' drop-down list below to specify the Assay element to be used for calculating the adjustment value.

Tip: If you require 'No adjustment' or adjustment 'by Fixed value', select the corresponding option from the 'Adjustment' drop-down list.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Analysis/Response data processing/choice/Adjustment/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Response data processing/choice/Adjustment/choice/

by Assay element

Select an option from the 'Assay element' drop-down list below to specify the Assay element to be used for calculating the normalization value.

Note: By default, the normalization you select is applied to every response value. Add a scope from the Creatable elements pane to restrict its application to an Assay element type, Assay element, or Rack.
Tip: If you require 'No normalization' or normalization 'by Fixed value', select the corresponding option from the 'Normalization' drop-down list.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Normalization/choice/

by Assay element

Select an option from the 'Assay element' drop-down list below to specify the Assay element to be used for calculating the normalization value.

Tip: If you require 'No normalization' or normalization 'by Fixed value', select the corresponding option from the 'Normalization' drop-down list.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Analysis/Response data processing/choice/Normalization/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Response data processing/choice/Normalization/choice/

by Fixed value

Enter a number to specify the Fixed value to be subtracted from your response values.

Tip: If you require 'No adjustment' or adjustment 'by Assay element', select the corresponding option from the drop-down list.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:double 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Analysis/Response data processing/choice/Adjustment/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Response data processing/choice/Adjustment/choice/

by Fixed value

Enter a number to specify the Fixed value to be subtracted from your response values.

Note: By default, the number you enter is subtracted from every response value. Add a scope from the Creatable elements pane to restrict its application to an Assay element type, Assay element, or Rack.
Tip: If you require 'No adjustment' or adjustment 'by Assay element', select the corresponding option from the drop-down list.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:double 1...1 required none

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Adjustment/choice/

by Fixed value

Enter a number to specify the Fixed value by which your response values are to be divided.

Tip: If you require 'No normalization' or normalization 'by Assay element', select the corresponding option from the drop-down list.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:double 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Analysis/Response data processing/choice/Normalization/choice/

/Cylinder-plate assay (USP <81>)/Analysis/Response data processing/choice/Normalization/choice/

by Fixed value

Enter a number to specify the Fixed value by which your response values are to be divided.

Note: By default, every response value is divided by the number you enter. Add a scope from the Creatable elements pane to restrict its application to an Assay element type, Assay element, or Rack.
Tip: If you require 'No normalization' or normalization 'by Assay element', select the corresponding option from the drop-down list.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:double 1...1 required none

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Normalization/choice/

Column: Assay test state

Expand the node to add or view information.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Combination of microbial assays/Potency data/

Column: Boolean

Define a column that allows you to associate each observation with a Boolean value.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...unbounded optional none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/choice/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/choice/

Column: Combination group

Expand the node to add or view information.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Combination of microbial assays/Potency data/

Column: Date

Define a column that allows you to associate each observation with a date.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...unbounded optional none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/choice/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/choice/

Column: Date/time

Define a column that allows you to associate each observation with a date and time.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...unbounded optional none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/choice/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/choice/

Column: Document reference

Expand the node to add or view information.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...1 optional none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/

Column: Document reference

Expand the node to add or view information.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Combination of microbial assays/Potency data/

Column: Exclude from calculation

Expand the node to add or view information.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Combination of microbial assays/Potency data/

Column: Floating-point number

Define a column that allows you to associate each observation with a value of double-precision floating-point number format.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...unbounded optional none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/choice/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/choice/

Column: Integer

Define a column that allows you to associate each observation with a value of integer number format.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...unbounded optional none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/choice/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/choice/

Column key

Displays the Column key.

Note: The key is used to identify the column, for example, in data acquisition.
Note: The key is required to define a sort order based on this column.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:token 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/Column: Response value/

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/Column: Position factor/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/Column: Response value/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/Column: Position factor/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/Column: Response value/

Column key

Displays the Column key.

Note: You cannot change the key of this column.
Note: The key is required to define a sort order based on this column.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:token 1...1 required none

Context:

/Combination of microbial assays/Potency data/Column: Section/

/Combination of microbial assays/Potency data/Column: Document reference/

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/Column: Section/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/Column: Section/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/Column: Section/

Column: Memo (multiline text)

Define a column that allows you to associate each observation with a multiline text.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...unbounded optional none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/choice/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/choice/

Column: Observation group

Links individual observations (measurements, data table rows) to their assay element (sample).

Each observation group comprises the observations of a single assay element (sample). The unique ID of the observation group is set in the definition of the assay element.

This data table column is named Observation group ID by default. It displays both the observation group ID and the assay element name for each observation.

Note: The Maximal group number limits the number of observation groups (assay elements) for which the Observations editor can display data. If your assay document has more assay elements, you require more observation groups and must change the Maximal group number accordingly.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/

Column: Position factor

Define up to two columns that allow you to associate each observation with the position where the observation occurred.

Note: Use the mandatory Plate position factor column below rather than this general position factor column to specify the plate number of each observation.
Tip: Use a general position factor column to specify the position of each observation on the plate, for example. By default, each plate has four positions (cylinders or cavities).

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...1 optional none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/

Column: Position factor

Provides a column in the data table that allows you to associate each observation with a plate.

Note: This position factor column is required for the calculation of the assay.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/

Column: Position factor

Provides a column in the data table that allows you to associate each observation with a plate.

Note: This position factor column is required for the calculation of the assay.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Cylinder-plate assay (USP <81>)/Setup/Observation data/

Column: Position factor

Define up to three columns that allow you to associate each observation with the position where the observation occurred.

If you work with a tube rack, for example, define two position factor columns to specify the tube rack row and column of each observation. If you work with several tube racks, define a third position factor column to provide the rack number of each observation.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...3 optional none

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/

Column: Position factor

Define up to three columns that allow you to associate each observation with the position where the observation occurred.

Note: Use the mandatory Plate position factor column below rather than this general position factor column to specify the plate number of each observation.
Tip: Use a general position factor column to specify the position of each observation on the plate, for example. By default, each plate has six positions (cylinders).

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...2 optional none

Context:

/Cylinder-plate assay (USP <81>)/Setup/Observation data/

Column: Potency

Expand the node to add or view information.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Combination of microbial assays/Potency data/

Column: Potency unit

Expand the node to add or view information.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Combination of microbial assays/Potency data/

Column: Response value

Holds the response values of individual observations.

You can acquire the values using one of our Data Acquisition Modules, copy and paste them from an external application such as a spreadsheet, or type them in manually.

This data table column is named Response by default.

Note: The data type of this column is double-precision floating-point number.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/

Column: Section

Expand the node to add or view information.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Combination of microbial assays/Potency data/

Data type Multiplicity Usage Default value
Node 0...1 optional none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/

Column: Sequence step

Links individual observations (measurements, data table rows) to their dilution sequence step.

The step number is implied by how you set up the concentration sequence either in the Standard assay element (USP <81> cylinder plate and turbidimetric documents) or in the Assay design section (JP 4.02 cylinder plate documents).

This data table column is named Sequence step by default. It displays both the sequence step number and the dose value for each observation.

Note: The total number of steps and replicates of an assay element (Standard, Test sample, or Control) is defined by the properties of the Standard and the Assay design.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/

Column: Technical-outlier flag

Provides a column to flag technical outliers in the data table.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/

Column: Text

Define a column that allows you to associate each observation with a single-line text.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...unbounded optional none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/choice/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/choice/

Column: Time

Define a column that allows you to associate each observation with a time.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...unbounded optional none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Observation data/choice/

/Cylinder-plate assay (USP <81>)/Setup/Observation data/choice/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Observation data/choice/

Combination group

Enter a combination group name to mark the sample for grouping in a combination of assays calculation as defined by USP <81>. Combination groups only apply when a Combination of microbial assays document draws data from assay documents that contain more than one sample. In this case, the combination of assays calculation combines the samples of each Combination group separately.

Note: The Combination group does not affect the calculations and results of this assay. You need to set up a separate Combination of microbial assays document to do the actual combination calculation.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:token 0...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Assay elements/Test/

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Test/

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Control/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Test/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Control/

Combination of microbial assays

Combination of microbial assays documents provide the features you need to apply confidence limits and perform combination of assays calculations.

Navigate through the properties to select or enter settings you require for this Combination of microbial assays:

1. Expand the node to add or view information.

  • The second level of the document structure displays the Name and Date of the document.
  • It also provides access to the Documentation, Potency data, and Analysis sections.

2. Double-click the Comment element in the Creatable elements pane to add a Comment section to the document.

Note: To delete an element from the document, right-click the element in the document structure and select the Delete element option from the pop-up menu.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

Top level

Comment

Enter a comment, or add a reference to a comment document.

Tip: You can add several Comment elements. And to each Comment element, you can add a Subject element, Text elements, and Linked document elements.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...unbounded optional none

Context:

/Combination of microbial assays/

/Cylinder-plate assay (JP 4.02)/

/Cylinder-plate assay (USP <81>)/

/Turbidimetric assay (USP <81>, JP 4.02)/

Concentration

Select the concentration at which the response is to be tested.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:token 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Sample response standard deviation/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Sample response standard deviation/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Sample relative response standard deviation/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Sample relative response standard deviation/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Sample mean response/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Sample mean response/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Assay suitability tests/choice/Test: Sample response sum/

/Cylinder-plate assay (JP 4.02)/Analysis/Test system/Sample suitability tests/choice/Test: Sample response sum/

Concentration

Enter a decimal number greater than zero to specify the working concentration to be used by the calculation for this step of the concentration sequence.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:double 1...1 required none

Context:

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Standard/Stepwise concentration sequence/choice/Concentration step/

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Standard/Stepwise concentration sequence/choice/Reference step/

Data type Multiplicity Usage Default value
xs:double 1...unbounded required none

Context:

Concentration step

This section allows you to define an individual step of the concentration sequence.

Tip: Add additional Concentration step elements as you require.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...unbounded required none

Context:

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Standard/Stepwise concentration sequence/choice/

Concentration unit

Enter the unit to be used for the concentrations of this sequence. This is the concentration unit of your stock solution. The unit you enter here applies to all concentration steps of the sequence.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:token 1...1 required none

Context:

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Standard/Stepwise concentration sequence/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Standard/Stepwise concentration sequence/

Confidence level (%)

Select the confidence level to be used for calculating the confidence interval. A common value is 95%.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:double 1...1 required none

Context:

/Combination of microbial assays/Analysis/

Configuration

Configure the document reference.

Expand the node to add or view information.

Add elements to change the document selection and generation process. You can restrict the selected document to a particular folder, for example. Consult the manual for additional information.

The following child elements are available:

  • Update mode
  • Template key
  • Folder key
  • Allow subfolders
  • Generator key
  • Document mode

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

/Combination of microbial assays/Documentation/Operator/choice/Operator reference/

/Combination of microbial assays/Documentation/Equipment/choice/Equipment reference/

/Cylinder-plate assay (JP 4.02)/Documentation/Operator/choice/Operator reference/

/Cylinder-plate assay (JP 4.02)/Documentation/Equipment/choice/Equipment reference/

/Cylinder-plate assay (USP <81>)/Documentation/Operator/choice/Operator reference/

/Cylinder-plate assay (USP <81>)/Documentation/Equipment/choice/Equipment reference/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Operator/choice/Operator reference/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Equipment/choice/Equipment reference/

Control

This section allows you to provide information on a Control sample.

Note: The system treats Control samples in the same way as Test samples.

Expand the node to add or view information.

Tip: The Combination group element allows you to mark Test samples and Control samples for grouping in a combination of assays calculation as defined by USP <81>. You need to set up a separate Combination of microbial assays document to do the actual combination calculation.
Tip: Suitability tests allow you to set a test scope based on assay element type such as Control samples only.
Tip: To provide information on the substance: Add the elements you need, such as Substance name or Substance reference, from the Creatable elements pane.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...unbounded optional none

Context:

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/

Cylinder-plate assay (JP 4.02)

Cylinder-plate assay (JP 4.02) documents provide the features you need to determine the potency of antibiotics according to the cylinder-plate method described in the JP 4.02 guideline.

Navigate through the properties to select or enter settings you require for this Cylinder-plate assay (JP 4.02):

1. Expand the node to add or view information.

  • The second level of the document structure displays the Name and Date of the document.
  • It also provides access to the Documentation, Setup, and Analysis sections.

2. Double-click the Comment element in the Creatable elements pane to add it to the document.

Note: To delete an element from the document, right-click the element in the document structure and select the Delete element option from the pop-up menu.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

Top level

Cylinder-plate assay (USP <81>)

Cylinder-plate assay (USP <81>) documents provide the features you need to determine the potency of antibiotics according to the cylinder-plate method described in the USP <81> guideline.

Navigate through the properties to select or enter settings you require for this Cylinder-plate assay (USP <81>):

1. Expand the node to add or view information.

  • The second level of the document structure displays the Name and Date of the document.
  • It also provides access to the Documentation, Setup, and Analysis sections.

2. Double-click the Comment element in the Creatable elements pane to add it to the document.

Note: To delete an element from the document, right-click the element in the document structure and select the Delete element option from the pop-up menu.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 1...1 required none

Context:

Top level

Cylinders per plate

Enter a number to specify how many cylinders this assay requires on each plate.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:integer 1...1 required none

Context:

/Cylinder-plate assay (USP <81>)/Setup/Assay design/

Date

Automatically inserts the current date and time when the Date element is created. You can enter a different date and time.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:dateTime 1...1 required none

Context:

/Combination of microbial assays/Comment/

/Cylinder-plate assay (JP 4.02)/Comment/

/Cylinder-plate assay (USP <81>)/Comment/

/Turbidimetric assay (USP <81>, JP 4.02)/Comment/

Date

Automatically inserts the current date and time when the document is created. You can enter a different date and time.

Tip: Use the date for sorting in aggregation documents.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:dateTime 1...1 required none

Context:

/Combination of microbial assays/

/Cylinder-plate assay (JP 4.02)/

/Cylinder-plate assay (USP <81>)/

/Turbidimetric assay (USP <81>, JP 4.02)/

Data source

This section provides information on imported data.

Expand the node to add or view information.

Note: Import information provided in this section was supplied by the import module.
Tip: Add an Import comment element to provide additional information.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...unbounded optional none

Context:

/Combination of microbial assays/Documentation/

/Cylinder-plate assay (JP 4.02)/Documentation/

/Cylinder-plate assay (USP <81>)/Documentation/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/

Deactivated

Select the Activated option from the drop-down list to enable Replicate averaging.

This element has the following attributes:

Data type Multiplicity Usage Default value
Empty 1...1 required none

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/Analysis/Response data processing/choice/Replicate averaging/choice/

Display color

Select the color to be used to display data of this assay element in graphs and tables. When you create an assay element, a color is automatically assigned. Select the color field to display controls that allow you to change the color.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:string 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Setup/Assay elements/Standard/

/Cylinder-plate assay (JP 4.02)/Setup/Assay elements/Test/

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Standard/

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Test/

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Control/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Standard/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Test/

/Turbidimetric assay (USP <81>, JP 4.02)/Setup/Assay elements/Control/

Document mode

Select a Document mode from the drop-down list to require referenced documents match this mode.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:token 0...1 optional none

Context:

/Combination of microbial assays/Potency data/Column: Document reference/

Document property filter

Define a filter based on a document property to require referenced documents match this property.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...unbounded optional none

Context:

/Combination of microbial assays/Potency data/Column: Document reference/

Document type

Select the document type of the documents to be referenced.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:token 0...1 optional none

Context:

/Combination of microbial assays/Potency data/Column: Document reference/

Documentation

This section allows you to provide information on operators, analyte, reagents, and equipment.

To provide information on the substance: Add the elements you need, such as Substance name or Substance reference, from the Creatable elements pane.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...1 optional none

Context:

/Combination of microbial assays/

Documentation

This section allows you to provide information on operators, analyte, reagents, and equipment. You can also add subsections that are specifically designed for detailed information on Inoculum, Base layer, Incubation, and Sample volume per cylinder.

To provide information on the substance: Add the elements you need, such as Substance name or Substance reference, from the Creatable elements pane.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...1 optional none

Context:

/Cylinder-plate assay (JP 4.02)/

Documentation

This section allows you to provide information on operators, analyte, reagents, and equipment. You can also add subsections that are specifically designed for detailed information on Inoculum and Incubation.

To provide information on the substance: Add the elements you need, such as Substance name or Substance reference, from the Creatable elements pane.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...1 optional none

Context:

/Turbidimetric assay (USP <81>, JP 4.02)/

Documentation

This section allows you to provide information on operators, analyte, reagents, and equipment. You can also add subsections that are specifically designed for detailed information on Inoculum, Base layer, and Incubation.

To provide information on the substance: Add the elements you need, such as Substance name or Substance reference, from the Creatable elements pane.

This element has the following attributes:

Data type Multiplicity Usage Default value
Node 0...1 optional none

Context:

/Cylinder-plate assay (USP <81>)/

Duration

Enter the time required for incubation.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:token 1...1 required none

Context:

/Cylinder-plate assay (JP 4.02)/Documentation/Inoculum/Test organism/Incubation/

/Cylinder-plate assay (JP 4.02)/Documentation/Incubation/

/Cylinder-plate assay (USP <81>)/Documentation/Inoculum/Test organism/Incubation/

/Cylinder-plate assay (USP <81>)/Documentation/Incubation/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Inoculum/Test organism/Incubation/

/Turbidimetric assay (USP <81>, JP 4.02)/Documentation/Incubation/