Active Ingredient PDS Attributes
You can use the PDS attributes to describe the active ingredients.
| Attribute | Description |
|---|---|
| Active Ingredient | Active ingredient for which this detail is created. |
| Active Ingredient Comments | Free format text box where users can enter comments. |
| Active Ingredient Description | Free format text box for entering descriptive information. |
| Active Ingredient Keywords | Free format text box where users can enter text for searching purposes. |
| Active Ingredient Scale | Free format text box for describing the volume at which a manufacturer is producing an active ingredient. For example: lab-scale, development scale or production scale. |
| Active Ingredient Status | Status of the detail - non configurable - values are Pending, Approved, Not Approved. |
| Active Ingredient Status Date | Date on which the status of the detail was set. |
| AI Animal/Human Origin | Indicates if a substance is of animal or human origin. |
| AI animal/human origin certificate filed? | Indicates if a certificate was filed. |
| Application Code | Code identifying the application associated with the PDS. |
| Application Name | Name of the application associated with the PDS. |
| Compendial Designation/Source | Compendial designation/Source is related to Pharmacopoeia - and should contain all values for which approval is requested/given. For example: USP, PhEUR, JP |
| Component Name | Component to which this detail is associated. |
| Composition Grouping Description | Description of composition grouping for the active ingredient. You cannot modify the description after saving. |
| Concentration Measure Type | Used with other attributes to specify information about the concentration of the active ingredient. Values: Equal, Range, Up to, or Not Less Than. |
| Date QC'd | The date the QC Status was set. |
| Drug Safety Alerts | Information related to drug safety for this active ingredient. |
| Family Code | Product family with which the PDS is associated. |
| Family Name | Product family with which the PDS is associated. |
| High Amount Denominator Prefix | The high limit amount denominator value. Must only be specified when a Range is described. Must be a Value from the published list. |
| High Amount Denominator Unit | The high limit amount denominator unit. Must only be specified when a Range is described. Must be a Value from the published list. |
| High Amount Denominator Value | The high limit amount denominator value. Must only be specified when a Range is described. |
| High Amount Numerator Prefix | The high limit amount numerator prefix must only be specified when a Range is described. Must be a Value from the published list. |
| High Amount Numerator Unit | The high limit amount numerator unit must only be specified when a Range is described. Must be a Value from the published list. |
| High Amount Numerator Value | The high limit amount numerator value. Must only be specified when a Range is described. |
| Low Amount Denominator Prefix | The low limit amount denominator prefix or, for non-range measurements, the amount denominator prefix. Must be a Value from the published list. |
| Low Amount Denominator Unit | The low limit denominator unit or, for non-range measurements, the amount numerator unit. Must be a Value from the published list. |
| Low Amount Denominator Value | The low limit amount denominator value or, for non-range measurements, the amount denominator value. |
| Low Amount Numerator Prefix | The low limit amount numerator prefix or, for non-range measurements, the amount numerator prefix. Must be a Value from the published list. |
| Low Amount Numerator Unit | The low limit amount numerator unit or, for non-range measurements, the amount numerator unit. Must be a Value from the published list. |
| Low Amount Numerator Value | The low limit amount numerator value or, for non-range measurements, the amount numerator value. |
| Measurement Point | The physical or logical location at which a condition is described. |
| Origin of Substance | Name of the substance source for the active ingredient. You cannot modify the value after saving. |
| Product Detail Set Name | PDS with which this detail is associated. |
| Product Name | Full concatenated product name to which the PDS/Template is associated. |
| QC Status | QC Status of the detail. |
| QC'd by | Person logged on to the system who set the QC Status for the detail to QC Passed or QC Failed. |
| Retest Interval | Retest interval requirements for this active ingredient. |
| Storage Conditions | Storage conditions requirements for this active ingredient. |
| Storage Container | Storage container requirements for this active ingredient. |