Active Ingredient Active Moiety Relationship Validation Procedure

$179 / year

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.

Complexity

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.

Date Created

2016-03-08

Last Modified

2019-03-05

Version

2019-03-05

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

US Food and Drug Administration, F.D.A. (2016). FDA.gov. Retrieved 16 April, 2016.

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

NameDescriptionTypeConstraints
Active_Ingredient_UNIIActive Ingredient Unique Ingredient Identifier (UNII)stringrequired : 1
Name_of_Active_IngredientName of biologically active ingredientstringrequired : 1
Active_Moiety_UNIIActive Moiety Unique Ingredient Identifier (UNII)stringrequired : 1
Name_of_Active_MoietyName of active molecule or ionstringrequired : 1
Basis_of_StrengthValue: Active Ingredient, Active Moiety, Reference Drugstring-
Referenced_Drug_UNIIstring-
Name_of_Referenced_DrugName of referenced drugstring-
Active Ingredient UNIIName of Active IngredientActive Moiety UNIIName of Active MoietyBasis of StrengthReferenced Drug UNIIName of Referenced Drug
FFM269698K((1-(.BETA.-MERCAPTO-.BETA.,.BETA.-CYCLOPENTAMETHYLENE PROPIONIC ACID), 2-(O-METHYL)TYROSINE))ARGININE VASOPRESSINFFM269698K((1-(.BETA.-MERCAPTO-.BETA.,.BETA.-CYCLOPENTAMETHYLENE PROPIONIC ACID), 2-(O-METHYL)TYROSINE))ARGININE VASOPRESSINActive Ingredient
F43I396OIS.ALPHA.1-PROTEINASE INHIBITOR HUMANF43I396OIS.ALPHA.1-PROTEINASE INHIBITOR HUMANActive Ingredient
I909J9CFAT.ALPHA.-AMYLASE (ASPERGILLUS ORYZAE)I909J9CFAT.ALPHA.-AMYLASE (ASPERGILLUS ORYZAE)Active Ingredient
8ID597Z82X.ALPHA.-KETOGLUTARIC ACID8ID597Z82X.ALPHA.-KETOGLUTARIC ACIDActive Ingredient
73Y7P0K73Y.ALPHA.-LIPOIC ACID73Y7P0K73Y.ALPHA.-LIPOIC ACIDActive Ingredient
H4N855PNZ1.ALPHA.-TOCOPHEROLH4N855PNZ1.ALPHA.-TOCOPHEROLActive Ingredient
9E8X80D2L0.ALPHA.-TOCOPHEROL ACETATEH4N855PNZ1.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-