Others titles
- Active Ingredient-Active Moiety Relationship/Basis of Strength
- Active Ingredient-Active Moiety Validation Procedures
Keywords
- Product Labels
- Structured Products
- SPL
- Drug Dictionary
- Pharmaceutical Dictionary
- Drug Names
- Method Validation
- Drug Label
- API
- Drug Active Ingredients
Active Ingredient Active Moiety Relationship Validation Procedure
This dataset is a Structured Product Labeling (SPL) Terminology File for SPL validation procedures and contains information on performing SPL validation regarding Active Ingredient-Active Moiety Relationship/Basis of Strength.
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Description
Validation procedures can be used by humans as check-lists to verify if their submission is correct. These are written specific and operational so that they may be checked by systems processing SPL documents.
Detailed validation procedures for this file are as follow:
– Active Ingredient Validation Procedures:
– Class code for active ingredients are ACTIB, ACTIM or ACTIR (The class code for active ingredient is dependent on the basis of the strength. If the basis of strength is the active ingredient, the class code is “ACTIB”. If the basis of strength is the active moiety, the class code is “ACTIM”. If the basis of strength is a reference drug, the class code is “ACTIR”.
– If the document type is for ‘bulk ingredient’ (53409-9) with a marketing category of ‘bulk ingredient’ (C73626), then there is one and only one active ingredient.
– If the product has no parts and is not a part, then there are one or more active ingredients.
– If the product has parts, then the active ingredients are under parts
– There is a strength with a numerator and denominator
– If the document type is for ‘bulk ingredient’ (53409-9) with a marketing category of ‘bulk ingredient’ (C73626), then numerator and denominator (representing strength amount) are the same.
– The strength numerator is based on mass (e.g., mg or g) and not volume (e.g.mL or L), except for ingredients such as water, alcohol, and gases.
– Active Moiety Validation Procedures:-
– There are one or two active moieties
– There is an active moiety code (UNII)
– Code system is 2.16.840.1.113883.4.9
– There is an active moiety name for each active moiety
– If the active ingredient is in the active-ingredient-active-moiety-validation-list, then the active moiety and basis of strength is the corresponding active moiety and basis of strength respectively in this list, except if the document type is for bulk ingredient (53409-9) and Drug for Further Processing (78744-0).
– If the active ingredient is not in the active-ingredient-active-moiety-validationlist, then the active moiety name does not include any of the names in the active moiety validation (counter ion) list, except if the word appears by itself optionally followed by “(ester)”, “cation” or “anion” or “ion”.
– Active moiety name matches the code (UNII)
– Reference Ingredient for Strength Validation Procedures:
– If the class code is ACTIR, then there is an asEquivalentSubstance element with a defining substance
– If the class code is not ACTIR, then there is no asEquivalentSubstance element
– There is a reference ingredient code
– Code system is 2.16.840.1.113883.4.9
– There is a name (preferred substance name)
– The name matches the code (UNII)
– If the document type code is 53404-0 (Vaccine Label) and if there is any active ingredient under the main product or under its first part, then at least one active ingredient code is on the list of active ingredients approved for vaccines.
About this Dataset
Data Info
Date Created | 2016-03-08 |
---|---|
Last Modified | 2022-08-17 |
Version | 2022-08-17 |
Update Frequency |
Irregular |
Temporal Coverage |
N/A |
Spatial Coverage |
United States |
Source | John Snow Labs; U.S. Food & Drug Administration (FDA); |
Source License URL | |
Source License Requirements |
N/A |
Source Citation |
N/A |
Keywords | Product Labels, Structured Products, SPL, Drug Dictionary, Pharmaceutical Dictionary, Drug Names, Method Validation, Drug Label, API, Drug Active Ingredients |
Other Titles | Active Ingredient-Active Moiety Relationship/Basis of Strength, Active Ingredient-Active Moiety Validation Procedures |
Data Fields
Name | Description | Type | Constraints |
---|---|---|---|
Active_Ingredient_UNII | Active Ingredient Unique Ingredient Identifier (UNII) | string | required : 1 |
Name_of_Active_Ingredient | Name of biologically active ingredient | string | required : 1 |
Active_Moiety_UNII | Active Moiety Unique Ingredient Identifier (UNII) | string | required : 1 |
Name_of_Active_Moiety | Name of active molecule or ion | string | required : 1 |
Basis_of_Strength | Value: Active Ingredient, Active Moiety, Reference Drug | string | - |
Referenced_Drug_UNII | string | - | |
Name_of_Referenced_Drug | Name of referenced drug | string | - |
Data Preview
Active Ingredient UNII | Name of Active Ingredient | Active Moiety UNII | Name of Active Moiety | Basis of Strength | Referenced Drug UNII | Name of Referenced Drug |
FFM269698K | 1-(.BETA.-MERCAPTO-.BETA.,.BETA.-CYCLOPENTAMETHYLENE PROPIONIC ACID), 2-(O-METHYL)TYROSINE))ARGININE VASOPRESSIN | FFM269698K | 1-(.BETA.-MERCAPTO-.BETA.,.BETA.-CYCLOPENTAMETHYLENE PROPIONIC ACID), 2-(O-METHYL)TYROSINE))ARGININE VASOPRESSIN | Active Ingredient | ||
F43I396OIS | .ALPHA.1-PROTEINASE INHIBITOR HUMAN | F43I396OIS | .ALPHA.1-PROTEINASE INHIBITOR HUMAN | Active Ingredient | ||
I909J9CFAT | .ALPHA.-AMYLASE (ASPERGILLUS ORYZAE) | I909J9CFAT | .ALPHA.-AMYLASE (ASPERGILLUS ORYZAE) | Active Ingredient | ||
8ID597Z82X | .ALPHA.-KETOGLUTARIC ACID | 8ID597Z82X | .ALPHA.-KETOGLUTARIC ACID | Active Ingredient | ||
73Y7P0K73Y | .ALPHA.-LIPOIC ACID | 73Y7P0K73Y | .ALPHA.-LIPOIC ACID | Active Ingredient | ||
H4N855PNZ1 | .ALPHA.-TOCOPHEROL | H4N855PNZ1 | .ALPHA.-TOCOPHEROL | Active Ingredient | ||
9E8X80D2L0 | .ALPHA.-TOCOPHEROL ACETATE | H4N855PNZ1 | .ALPHA.-TOCOPHEROL | |||
A7E6112E4N | .ALPHA.-TOCOPHEROL ACETATE, D- | N9PR3490H9 | .ALPHA.-TOCOPHEROL, D- | Active Moiety | ||
WR1WPI7EW8 | .ALPHA.-TOCOPHEROL ACETATE, DL- | 7QWA1RIO01 | .ALPHA.-TOCOPHEROL, DL- | Active Moiety | ||
BVK87L5TNB | .ALPHA.-TOCOPHEROL CALCIUM SUCCINATE, D- | N9PR3490H9 | .ALPHA.-TOCOPHEROL, D- |