S–Z

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

Sample correction method

Corrects for plate-to-plate variation to determine the corrected average zone measurements for both Test and Control samples. Select the type of value to be employed. Default is the Correction point as defined in USP <81>.

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

  • Correction point (mean reference step response): Employs the mean of all measurements for the reference step that are obtained from the plates used for the Standard sample. This value is also used for the regression of the Standard sample.
  • Estimated reference step response: Employs the estimated response value on the regression curve of the Standard sample that corresponds to the concentration of the reference step.

This element has the following attributes:

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

Context:

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

Sample suitability tests

Add the Sample suitability tests you require.

Important: The results of Sample suitability tests just affect the individual assay elements that are evaluated rather than the whole 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)/Analysis/Test system/

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

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

Sample volume per cylinder

Enter the volume of the sample to be used per cylinder.

This element has the following attributes:

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

Context:

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

Section key

Enter a Section key to restrict the data to the section identified by the key.

Note: The key only applies to document aggregation.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:token 0...1 optional 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/

Section property filter

Define a filter based on a section 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/

Seed layer

This documentation section allows you to provide information on the seed layer medium and volume per plate. 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/Inoculum/

Seed layer volume per plate

Enter the volume of the seed layer to be used per plate.

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/Seed layer/

Sequence step

Enter the sequence step of the assay element to be used for calculating the normalization factor.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:nonNegativeInteger 0...1 optional 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/

Sequence step

Enter the sequence step of the assay element to be used for calculating the adjustment value.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:nonNegativeInteger 0...1 optional 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/

Sets per plate

Enter the number of sets to be placed on each plate.

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

Tip: Sets per plate is set to '1' by default, which is the correct value for Petri dishes, for example, as recommended by JP 4.02.

This element has the following attributes:

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

Context:

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

Setup

This section allows you to set up this assay.

Expand the node to add or view information.

This section provides the following features:

  • Assay design: Specifies 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).
  • Assay elements: Details both assay elements, that is, the Standard sample and the Test sample.
  • Observation data: Sets up the data table displayed in the Observations editor. The table is created automatically based on the information you provide on assay elements. But you can add or delete data columns such as the Document reference and Position factor columns.

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

This section allows you to set up this assay.

Expand the node to add or view information.

This section provides the following features:

  • Assay design: Specifies 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.
  • Assay elements: Details all assay elements, that is, Standard sample, Test samples, and Control samples.
  • Observation data: Sets up the data table displayed in the Observations editor. The table is created automatically based on the information you provide on assay elements. But you can add or delete data columns such as the Document reference and Position factor columns.

This element has the following attributes:

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

Context:

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

Setup

This section allows you to set up this assay.

Expand the node to add or view information.

This section provides the following features:

  • Assay elements: Details all assay elements, that is, Standard sample, Test samples, and Control samples.
  • Observation data: Sets up the data table displayed in the Observations editor. The table is created automatically based on the information you provide on assay elements. But you can add or delete data columns such as the Document reference and Position factor columns.

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)/

Severity level of the test

Select the Severity level of the test. The severity level controls how failed tests affect results.*

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

  • Reject: If the test fails, interpolated concentrations and additional calculation results are reported. For reporting the Overall test result, the test is considered 'Rejected'.
  • Warning: If the test fails, interpolated concentrations and additional calculation results are reported. For reporting the Overall test result, the test is considered 'Failed'.
  • Information: If the test fails, interpolated concentrations and additional calculation results are reported. For reporting the Overall test result, the test is considered 'Passed' (info available).
Note: Each microbial assay for antibiotics also provides a summary of test results, which is called 'Overall test result'.

The following table explains how the Severity levels of failed tests influence the Overall test result:

Overall test result Failed tests of severity level 'Rejected' Failed tests of severity level 'Warning' Failed tests of severity level 'Information'
Passed 0 0 0
Passed (info available) 0 0 ≥1
Failed 0 ≥1 any number
Rejected ≥1 any number any number
Note: If tests cannot be calculated and return 'not calculated' (NC) results (for example, if Fieller's formula is needed to calculate test results and computed values are outside the valid range), the Overall test result treats them like failed tests.

* When Assay suitability tests fail, they affect every sample in the assay. Sample suitability tests only affect the Overall test result of the individual sample.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Analysis/Test system/choice/Test: Combined potency - Value/

/Combination of microbial assays/Analysis/Test system/choice/Test: Half width of confidence interval/

/Combination of microbial assays/Analysis/Test system/choice/Test: Combined potency - Confidence interval/

/Combination of microbial assays/Analysis/Test system/choice/Test: Combined potency - Confidence interval (%)/

/Combination of microbial assays/Analysis/Test system/choice/Test: Combined potency - Range/

/Combination of microbial assays/Analysis/Test system/choice/Test: Combined potency - Range (%)/

/Combination of microbial assays/Analysis/Test system/choice/Test: Potency - CV (%)/

/Combination of microbial assays/Analysis/Test system/choice/Test: Number of valid assays (test state)/

/Combination of microbial assays/Analysis/Test system/choice/Test: Number of potency outliers/

/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/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: 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/

/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/

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

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

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

/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: Plate correction/

/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/Assay suitability tests/choice/Test: Potency of the working sample/

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

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

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

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

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

/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: Plate correction/

/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)/

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

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

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

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

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

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

/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/Assay suitability tests/choice/Test: Potency of the working sample/

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

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

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

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

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

/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)/

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

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

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

Species

Enter a designation, such as the species name, that indicates the test organism used in this assay.

Tip: You can enter single-line text of up to 200 characters.

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/

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

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

Square response transformation

Performs a square transformation of your response values.

Tip: If you require 'No transformation', 'Logarithmic', or 'Square root response transformation', select the corresponding option from the 'Transformation' drop-down list.

This element has the following attributes:

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

Context:

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

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

Square root response transformation

Performs a square root transformation of your response values.

Tip: If you require 'No transformation', 'Logarithmic', or 'Square response transformation', select the corresponding option from the 'Transformation' drop-down list.

This element has the following attributes:

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

Context:

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

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

Standard

This section allows you to provide information on the Standard, also referred to as standard sample or standard preparation.

Expand the node to add or view information.

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 1...1 optional none

Context:

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

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

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

Standard solutions

This section allows you to specify the potencies of the standard solutions, that is, the Potency of high concentration solution, Potency of low concentration solution, and 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:

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

Step name

Enter a name for the concentration step. This name is displayed in addition to the step number in the response data tables provided on the document dashboard and in reports.

Note: The names you assign to concentration steps are intended to improve the readability of the response data tables and do not influence the calculation of the document.

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/choice/Concentration step/

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

Stepwise concentration sequence

Allows you to define a concentration sequence by specifying the working concentration of each step individually.

To add a sequence step: Double-click Concentration step in the Creatable elements pane.

Note: Use the Reference step element rather than a Concentration step element to specify the median test dilution of the standard as defined by USP <81>.
Note: The position of each Concentration step element within the list defines its step number, which is displayed in the data table of the Observations editor.
Tip: To change the position of a Concentration step element in the list, select it and drag it up or down.

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 elements/Standard/

Stepwise concentration sequence

Allows you to define a concentration sequence by specifying the working concentration of each step individually.

To add a sequence step: Double-click Concentration in the Creatable elements pane.

Note: Use the Reference concentration element rather than a Concentration element to specify the median test dilution of the standard as defined by USP <81>.
Note: The position of each Concentration element within the list defines its step number, which is displayed in the data table of the Observations editor.
Tip: To change the position of a Concentration element in the list, select it and drag it up or down.

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/Standard/

Subject

Enter the subject of this comment.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:token 0...1 optional 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/

Substance batch/lot number

Enter the substance batch or lot number, a combination of numbers, letters, and/or symbols. It identifies a batch (or lot), which allows you to infer the production and distribution history.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/

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

/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>)/Documentation/

/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)/Documentation/

/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/

Substance class

Enter the class of the substance such as the drug class.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/

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

/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>)/Documentation/

/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)/Documentation/

/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/

Substance description

Enter a description of the substance.

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 (JP 4.02)/Setup/Assay elements/Standard/

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

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

/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)/Documentation/

/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/

Substance identification

Enter information to identify 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/

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

/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>)/Documentation/

/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)/Documentation/

/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/

Substance name

Enter a name for the substance.

Tip: You can enter a reference to a substance document instead. Select the Substance reference option from the drop-down list.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/choice/

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

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

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

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

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

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

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

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

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

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

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

Substance reference

Select a substance document.

Tip: You can enter a substance name instead. Select the Substance name option from the drop-down list.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/choice/

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

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

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

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

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

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

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

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

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

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

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

Substance sub-batch/sub-lot number

Enter the substance sub-batch or sub-lot number, a combination of numbers, letters, and/or symbols. It identifies a sub-batch (or sub-lot), which allows you to infer the production and distribution history.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/

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

/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>)/Documentation/

/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)/Documentation/

/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/

Substance variant

Enter the variant 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/

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

/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>)/Documentation/

/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)/Documentation/

/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/

Temperature

Enter the temperature 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/

Template key

Select a template to require referenced documents be generated by this template.

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/

Term

Enter a term to define the value of the related property. If you do not enter a term, only the Property key itself is used as a filter, not its value. If you define multiple terms, the system combines them using the logical OR, which means that only one of the terms has to match.

Tip: Use the asterisk (*) as a wildcard to cover several assay element Names with a single Term. Enter 'St*', for example, to aggregate Standard samples that are named 'Standard' or 'Std'.

Example: To aggregate Test samples, use a single term and enter 'Test' as its value. To aggregate both Test and Control samples, add a second term and enter 'Control' as its value.

This element has the following attributes:

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

Context:

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

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

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

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

Test: Absolute potency

Add one or several tests for the absolute potency to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

The absolute potency is determined as follows: The system interpolates a value for the mean response value of the sample. This value is transformed back if a dose transformation has been applied. And it is multiplied with the predilution of the sample.

Note: To pass the test, the absolute potency of the sample has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

Assay elements:

Test, Control

This element has the following attributes:

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

Context:

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

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

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

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

Test: Absolute potency

Add one or several tests for the absolute potency to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.
Note: To pass the test, the absolute potency has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

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/Test system/Assay suitability tests/choice/

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

Test: Coefficient of determination (R²)

Add one or several tests for the coefficient of determination (R²) to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.
Note: This test uses either R² or the adjusted R². They are only calculated for the Standard sample.

Select the R² value you want to test from the Type drop-down list. The following options are available:

  • regular
  • adjusted
Note: To pass the test, the R² of the regression fit has to be greater than or equal to the Lower margin set in the test definition.

This element has the following attributes:

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

Context:

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

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

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

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

Test: Combined potency - Confidence interval (%)

Add one or several tests for the combined potency confidence interval (%) to your assay.

The percentual combination potency confidence interval is determined as follows: The limits are obtained by (1) dividing the limits of the original confidence interval by the combined potency and (2) multiplying with 100.

Note: The test is applied for each combination group separately.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Analysis/Test system/choice/

Test: Combined potency - Confidence interval

Add one or several tests for the combined potency confidence interval to your assay.

The test uses the limits of the combined potency confidence interval as upper and lower value.

Note: The test is applied for each combination group separately.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Analysis/Test system/choice/

Test: Combined potency - Range (%)

Add one or several tests for the percentual combined potency range to your assay.

The percentual combined potency range is determined as follows: The upper limit of the range is obtained by (1) dividing the maximum potency by the combined potency and (2) multiplying with 100. The lower limit of the range is obtained by (1) dividing the minimum potency by the combined potency and (2) multiplying with 100.

Note: The test is applied for each combination group separately.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Analysis/Test system/choice/

Test: Combined potency - Range

Add one or several tests for the combined potency range to your assay.

The combined potency range is determined as follows: The maximum potency is used as upper limit of the range. The minimum potency is used as lower limit of the range.

Note: The test is applied for each combination group separately.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Analysis/Test system/choice/

Test: Combined potency - Value

Add one or several tests for the combined potency value to your assay.

The test uses the value of the combined potency obtained from the combination procedure.

Note: The test is applied for each combination group separately.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Analysis/Test system/choice/

Test: Combined standard deviation of the standard

Add one or several tests for the combined standard deviation of the standard to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

The combined standard deviation of the standard is determined by taking the square root of the average of the reponse variances for all steps of the stand standard sample.

Note: To pass the test, the combined standard deviation of the standard sample has to be less than or equal to the Upper margin set in the test definition.

Assay elements:

Standard

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/Test system/Assay suitability tests/choice/

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

Test: Correction point

Add one or several tests for the correction point to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.
Note: To pass the test, the value of the correction point for the standard has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

Assay elements:

Standard

This element has the following attributes:

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

Context:

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

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

Test: Correction point - Relative standard deviation CV (%)

Add one or several tests for the relative standard deviation CV (%) of the correction point to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.
Note: To pass the test, the relative standard deviation CV (%) of the correction point for the standard has to be less than or equal to the Upper margin set in the test definition.

Assay elements:

Standard

This element has the following attributes:

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

Context:

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

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

Test: Correction point - Standard deviation

Add one or several tests for the standard deviation of the correction point to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.
Note: To pass the test, the standard deviation of the correction point for the standard has to be less than or equal to the Upper margin set in the test definition.

Assay elements:

Standard

This element has the following attributes:

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

Context:

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

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

Test: Half width of confidence interval

Add one or several tests for the half width of the confidence interval to your assay.

The test uses the value of the interval half-width obtained by logarithmizing the limits of the potency confidence interval.

Note: The test is applied for each combination group separately.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Analysis/Test system/choice/

Test: Number of potency outliers

Add one or several tests for the number of potency outliers to your assay.

The test uses the number of potency outliers detected among logarithmized potency values. Since the outlier detection method is not recursive, this number is either '0' or '1'.

Note: The test is applied for each combination group separately.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Analysis/Test system/choice/

Test: Number of valid assays (test state)

Add one or several tests for the number of valid assays to your assay.

The test counts the assays that are valid according to their own test system. Assays marked as Technical outliers are excluded regardless of whether they are valid.

Note: The test is applied for each combination group separately.

Assays are considered valid if they are in one of the following states according to their own test system:

  • Passed
  • Passed (info)
  • No test results available

This element has the following attributes:

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

Context:

/Combination of microbial assays/Analysis/Test system/choice/

Test organism

This section allows you to provide information on the test organism and on how to incubate for preparation of the test organism inoculum. 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)/Documentation/Inoculum/

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

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

Test: Parameter/property point estimate

Add one or several tests for single parameters to your assay.

Note: The tests are for the fit parameters of the Standard sample.
Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

Select the parameter you want to test from the Parameter drop-down list. The following options are available:

  • Slope
  • Intercept

This element has the following attributes:

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

Context:

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

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

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

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

Test: Plate correction

Add one or several tests for the plate correction values to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.
Note: To pass the test, the plate correction value (reference mean minus correction point) for each set of plates has to be less than or equal to the Upper margin provided in the test definition. By default, the test is applied to every set of plates in the assay. Change the scope in the test definition to restrict its application to an Assay element type or Assay element.

Example: Your assay has 4 sets of plates for standard concentration steps and 1 set for the test sample. If you keep the default scope, the plate correction test is applied to each of the 5 plate correction values. If you keep 'Assay element type scope' and select the option 'Test samples only', the test is only applied to the plate correction value that relates to the set of plates with the test sample.

Assay elements:

All

This element has the following attributes:

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

Context:

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

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

Test: Potency - CV (%)

Add one or several tests for the percentual potency coefficient of variation (CV) to your assay.

The test uses the CV of the raw potency entries.

Note: The test is applied for each combination group separately.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Analysis/Test system/choice/

Test: Potency factor A

Add one or several tests for the potency factor A to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.
Note: To pass the test, the potency factor A has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

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/Test system/Assay suitability tests/choice/

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

Test: Potency of the working sample

Add one or several tests for the potency of the working sample to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

The potency of the working sample is determined as follows: The system interpolates a value for the mean response value of the sample. This value is transformed back if a dose transformation has been applied.

Note: To pass the test, the working concentration of the sample has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

Assay elements:

Test, Control

This element has the following attributes:

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

Context:

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

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

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

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

Test: Potency of the working sample

Add one or several tests for the working concentration to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.
Note: To pass the test, the working concentration has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

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/Test system/Assay suitability tests/choice/

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

Test: Relative potency (percentage of reference concentration)

Add one or several tests for the percentage of the reference concentration to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.

The percentage of the reference concentration is determined as follows: The system interpolates a value for the mean response value of the sample. This value is transformed back if a dose transformation has been applied. And it is divided by the delogarithmized mean dose value of the standard sample.

Note: To pass the test, the percentage of the reference concentration of the sample has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

Assay elements:

Test, Control

This element has the following attributes:

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

Context:

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

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

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

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

Test: Response range

Add one or several tests for the response range to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.
Note: To pass the test, all reponse values of the sample have to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

Assay elements:

All

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/Test system/Assay suitability tests/choice/

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

Test: Sample - Mean response

Add one or several tests for the sample mean response to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.
Note: To pass the test, the mean of all reponse values of the sample has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

Assay elements:

Test, Control

This element has the following attributes:

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

Context:

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

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

Test: Sample mean response

Add one or several tests for the mean response to your assay.

You can test the response for the High concentration or the Low concentration solution. Select the option you require from the Concentration drop-down list.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.
Note: To pass the test, the mean response at the concentration you select has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

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/Test system/Assay suitability tests/choice/

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

Test: Sample relative response standard deviation

Add one or several tests for the relative response standard deviation to your assay.

You can test the response for the High concentration or the Low concentration solution. Select the option you require from the Concentration drop-down list.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.
Note: To pass the test, the standard deviation at the concentration you select has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

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/Test system/Assay suitability tests/choice/

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

Test: Sample response standard deviation

Add one or several tests for the response standard deviation to your assay.

You can test the response for the High concentration or the Low concentration solution. Select the option you require from the Concentration drop-down list.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.
Note: To pass the test, the standard deviation at the concentration you select has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

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/Test system/Assay suitability tests/choice/

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

Test: Sample response sum

Add one or several tests for the response sum to your assay.

You can test the response for the High concentration or the Low concentration solution. Select the option you require from the Concentration drop-down list.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.
Note: To pass the test, the response sum at the concentration you select has to be greater than or equal to the Lower margin set in the test definition and less than or equal to the Upper margin.

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/Test system/Assay suitability tests/choice/

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

Test sample (unknown)

This section allows you to provide information on the Test sample.

Expand the node to add or view information.

Tip: The Combination group element allows you to mark Test samples for grouping in a combination of assays calculation. You need to set up a separate Combination of microbial assays document to do the actual combination calculation.
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 1...1 required none

Context:

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

Test sample (unknown)

This section allows you to provide information on a Test sample. The dose value of the test sample is interpolated using the regression curve of the standard sample.

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: 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/

Test: Step - Relative standard deviation CV (%)

Add one or several tests for the relative standard deviation CV (%) in the individual concentration steps to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.
Note: To pass the test, the relative standard deviation CV (%) of each step of the assay element (sample) has to be less than or equal to the Upper margin set in the test definition.

Assay elements:

All

This element has the following attributes:

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

Context:

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

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

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

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

Test: Step - Standard deviation

Add one or several tests for the standard deviation in the individual concentration steps to your assay.

Tip: Select the Assay suitability or Sample suitability section prior to adding tests from the Creatable elements pane.
Note: To pass the test, the standard deviation of each step of the assay element (sample) has to be less than or equal to the Upper margin set in the test definition.

Assay elements:

All

This element has the following attributes:

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

Context:

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

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

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

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

Test system

This section allows you to define the statistical tests you require for your cylinder-plate assay (JP 4.02).

The tests are organized into the following categories:

  • Assay suitability tests
  • Sample suitability tests

Expand the node to add or view information.

Note: Suitability tests are required to prove the validity of your assay runs.

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

This section allows you to define the statistical tests you require for analyzing the results of your Combination of microbial assays.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Analysis/

Test system

This section allows you to define the statistical tests you require for your turbidimetric assay (USP <81>, JP 4.02).

The tests are organized into the following categories:

  • Assay suitability tests
  • Sample suitability tests

Expand the node to add or view information.

Note: Suitability tests are required to prove the validity of your assay runs.

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/

Test system

This section allows you to define the statistical tests you require for your cylinder-plate assay (USP <81>).

The tests are organized into the following categories:

  • Assay suitability tests
  • Sample suitability tests

Expand the node to add or view information.

Note: Suitability tests are required to prove the validity of your assay runs.

This element has the following attributes:

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

Context:

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

Text

Enter your comment.

Tip: You can enter multiline text. You can also add additional Text elements.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:string 0...unbounded optional 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/

Transformation

Transform your response values using Logarithmic, Square, or Square root response transformation.

Expand the node to add or view information.

Example: Use this feature to mitigate problems caused by the heteroscedasticity of your response data.

This element has the following attributes:

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

Context:

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

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

Turbidimetric assay (USP <81>, JP 4.02)

Turbidimetric assay (USP <81>, JP 4.02) documents provide the features you need to determine the potency of antibiotics according to the turbidimetric methods described in the USP <81> and JP 4.02 guidelines.

Navigate through the properties to select or enter settings you require for this Turbidimetric assay (USP <81>, 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

Type (R²)

Select the method to be used from the drop-down list.

The following options are available:

  • regular: The test uses the regular R².
  • adjusted: The test uses the adjusted R².

This element has the following attributes:

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

Context:

/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: Coefficient of determination (R²)/

/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: Coefficient of determination (R²)/

Unit

Enter the unit of the response values.

This element has the following attributes:

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

Context:

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

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

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

Update mode

Select how you want to update document references and the data provided by these documents.

Tip: You can update data based on a list of referenced documents (update data) or a property filter (update all). To update data based on a property filter, you have to add a Document property filter or a Section property filter to the Document reference section.

The following four Update modes are available:

Mode Trigger Scope
Auto all Updates automatically when you open or close the document. Searches the entire database for data matching the property filter. Updates all matching data and the list of referenced documents.
Auto data Updates automatically when you open or close the document. Updates data from currently referenced documents.
Manual all Updates when you manually execute the update command in the References editor. Searches the entire database for data matching the property filter. Updates all matching data and the list of referenced documents.
Manual data Updates when you manually execute the update command in the References editor. Updates data from currently referenced documents.
Note: Only documents for which the requesting user has read permission are checked for updates.

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/

Update mode

Select how you want to update data provided by the referenced document.

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

  • Auto: Have data updated automatically.
  • Manual: Update data manually from the References dialog.

This element has the following attributes:

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

Context:

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

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

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

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

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

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

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

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

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

Context:

/Combination of microbial assays/Documentation/choice/Substance reference/Config/

/Combination of microbial assays/Documentation/Reagent/choice/Reagent reference/Config/

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

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

/Cylinder-plate assay (JP 4.02)/Setup/Assay elements/Standard/choice/Substance reference/Config/

/Cylinder-plate assay (JP 4.02)/Setup/Assay elements/Test/choice/Substance reference/Config/

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

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

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Standard/choice/Substance reference/Config/

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Test/choice/Substance reference/Config/

/Cylinder-plate assay (USP <81>)/Setup/Assay elements/Control/choice/Substance reference/Config/

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

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

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

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

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

Upper margin

Enter the Upper margin of the test as decimal number. To pass the test, the observed value must be less than or equal to the Upper margin.

Note: The system permits equal values for upper and lower margin.

Please consult the help page of the test for additional information.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Analysis/Test system/choice/Test: Combined potency - Value/

/Combination of microbial assays/Analysis/Test system/choice/Test: Half width of confidence interval/

/Combination of microbial assays/Analysis/Test system/choice/Test: Combined potency - Confidence interval/

/Combination of microbial assays/Analysis/Test system/choice/Test: Combined potency - Confidence interval (%)/

/Combination of microbial assays/Analysis/Test system/choice/Test: Combined potency - Range/

/Combination of microbial assays/Analysis/Test system/choice/Test: Combined potency - Range (%)/

/Combination of microbial assays/Analysis/Test system/choice/Test: Potency - CV (%)/

/Combination of microbial assays/Analysis/Test system/choice/Test: Number of valid assays (test state)/

/Combination of microbial assays/Analysis/Test system/choice/Test: Number of potency outliers/

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

/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: Parameter/property point estimate/

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

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

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

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

/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: Parameter/property point estimate/

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

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

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

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

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

/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: Plate correction/

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

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

/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: Plate correction/

/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: Coefficient of determination (R²)/

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

/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: Potency of the working sample/

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

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

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

/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: Potency of the working sample/

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

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

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

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

/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/Sample suitability tests/choice/Test: Step - Standard deviation/

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

/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/Assay suitability tests/choice/Test: Coefficient of determination (R²)/

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

Upper margin

Enter the Upper margin of the test as a decimal number that is greater than or equal to zero. To pass the test, the observed value must be less than or equal to the Upper margin.

Note: The system permits equal values for upper and lower margin.

Please consult the help page of the test for additional information.

This element has the following attributes:

Data type Multiplicity Usage Default value
xs:double 0...1 optional 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/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: 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/

/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/

User variable

Define user variables for custom reports/ custom component packages. They have no functionality in standard reports/ standard component packages.

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/

Value

Enter the value you want to use in custom reports/ custom component packages.

This element has the following attributes:

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

Context:

/Combination of microbial assays/Documentation/User variable/

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

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

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

Volume per plate

Enter the volume of base layer medium to be used per plate.

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/Base layer/

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