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

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Turbidimetric assay (USP <81>, JP 4.02)
.... Name
.... Date
.... Documentation
........ Assay purpose
........ Alternatives
............ Substance name
............ Substance reference
........ Substance identification
........ Substance batch/lot number
........ Substance sub-batch/sub-lot number
........ Substance variant
........ Substance class
........ Substance description
........ Operator
............ Alternatives
................ Operator name
................ Operator reference
.................... Configuration
........................ Update mode
............ Role
........ Reagent
............ Alternatives
................ Reagent name
................ Reagent reference
............ Reagent identification
............ Reagent batch/lot number
............ Reagent sub-batch/sub-lot number
............ Reagent variant
............ Reagent class
............ Reagent description
............ Amount
........ Equipment
............ Alternatives
................ Equipment name
................ Equipment reference
.................... Configuration
........................ Update mode
........ User variable
............ Key
............ Value
........ Data source
............ File name
............ Import time stamp
............ Import module identification
............ Import comment
........ Inoculum
............ Test organism
................ Species
................ Incubation
.................... Duration
.................... Temperature
.................... Incubation medium
........................ Ingredient
............................ Ingredient name
............................ Ingredient amount
........................ pH
............ Inoculum medium
................ Ingredient
.................... Ingredient name
.................... Ingredient amount
................ pH
............ Inoculum concentration
............ Inoculum volume per tube
........ Incubation
............ Duration
............ Temperature
.... Setup
........ Assay elements
............ Standard
................ Name
................ Observation group ID
................ Display color
................ Number of replicates
................ Stepwise concentration sequence
.................... Alternatives
........................ Concentration
........................ Reference concentration
.................... Concentration unit
................ Alternatives
.................... Substance name
.................... Substance reference
................ Substance identification
................ Substance batch/lot number
................ Substance sub-batch/sub-lot number
................ Substance variant
................ Substance class
................ Substance description
............ Test sample (unknown)
................ Name
................ Observation group ID
................ Display color
................ Number of replicates
................ Predilution
................ Combination group
................ Alternatives
.................... Substance name
.................... Substance reference
................ Substance identification
................ Substance batch/lot number
................ Substance sub-batch/sub-lot number
................ Substance variant
................ Substance class
................ Substance description
................ Exclude from analysis / invalid assay element
............ Control
................ Name
................ Observation group ID
................ Display color
................ Number of replicates
................ Predilution
................ Combination group
................ Alternatives
.................... Substance name
.................... Substance reference
................ Substance identification
................ Substance batch/lot number
................ Substance sub-batch/sub-lot number
................ Substance variant
................ Substance class
................ Substance description
................ Exclude from analysis / invalid assay element
........ Observation data
............ Observation source
............ Column: Document reference
............ Column: Section
................ Name
................ Column key
................ Property filter
.................... Property key
.................... Term
............ Row order
............ Column: Observation group
............ Column: Sequence step
............ Column: Response value
................ Name
................ Column key
................ Property scope
................ Property key
................ Section key
................ Unit
............ Column: Technical-outlier flag
............ Column: Position factor
............ Alternatives
................ Column: Boolean
................ Column: Date
................ Column: Date/time
................ Column: Floating-point number
................ Column: Integer
................ Column: Memo (multiline text)
................ Column: Text
................ Column: Time
.... Analysis
........ Response data processing
............ Alternatives
................ Adjustment
.................... Alternatives
........................ No adjustment
........................ by Fixed value
........................ by Assay element
............................ Assay element
............................ Sequence step
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
........................ Rack scope
................ Normalization
.................... Alternatives
........................ No normalization
........................ by Fixed value
........................ by Assay element
............................ Assay element
............................ Sequence step
.................... Alternatives
........................ Assay element type scope
........................ Assay element scope
........................ Rack scope
................ Transformation
.................... Alternatives
........................ No transformation
........................ Logarithmic response transformation
............................ Logarithm base
........................ Square response transformation
........................ Square root response transformation
................ Replicate averaging
.................... Alternatives
........................ Deactivated
........................ Activated
........ Alternatives
............ Logarithmic dose transformation
................ Logarithm base
............ No dose transformation
........ Test system
............ Assay suitability tests
................ Alternatives
.................... Test: Response range
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Step - Standard deviation
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Step - Relative standard deviation CV (%)
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Combined standard deviation of the standard
........................ Upper margin
........................ Lower margin
........................ Assay element type scope
........................ Severity level of the test
.................... Test: Parameter/property point estimate
........................ Parameter
........................ Upper margin
........................ Lower margin
........................ Assay element type scope
........................ Severity level of the test
.................... Test: Coefficient of determination (R²)
........................ Type (R²)
........................ Upper margin
........................ Lower margin
........................ Assay element type scope
........................ Severity level of the test
.................... Test: Potency of the working sample
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Absolute potency
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Relative potency (percentage of reference concentration)
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
............ Sample suitability tests
................ Alternatives
.................... Test: Response range
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Step - Standard deviation
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Step - Relative standard deviation CV (%)
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Combined standard deviation of the standard
........................ Upper margin
........................ Lower margin
........................ Assay element type scope
........................ Severity level of the test
.................... Test: Parameter/property point estimate
........................ Parameter
........................ Upper margin
........................ Lower margin
........................ Assay element type scope
........................ Severity level of the test
.................... Test: Coefficient of determination (R²)
........................ Type (R²)
........................ Upper margin
........................ Lower margin
........................ Assay element type scope
........................ Severity level of the test
.................... Test: Potency of the working sample
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Absolute potency
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.................... Test: Relative potency (percentage of reference concentration)
........................ Upper margin
........................ Lower margin
........................ Alternatives
............................ Assay element type scope
............................ Assay element scope
........................ Severity level of the test
.... Comment
........ Subject
........ Text
........ Linked document
........ Date
........ Author