Active Ingredient Active Moiety Relationship Validation Procedure

$79 / 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

2017-10-13

Version

2017-10-13

Update Frequency

Irregular

Temporal Coverage

N/A

Spatial Coverage

United States

Source

John Snow Labs => U.S. Food & Drug Administration (FDA)

Source License URL

John Snow Labs Standard License

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

Name Description Type Constraints
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
6QT214X4XUALOXIPRINR16CO5Y76EASPIRIN
3V6I5962EMPIVOPRIL9G64RSX1XDCAPTOPRIL
73J0P7720YCARBASALATER16CO5Y76EASPIRIN
X39TL7JDPFALACEPRIL9G64RSX1XDCAPTOPRIL
6429L0L52YDIPYRONE934T64RMNJMETAMIZOLE
P4A66LQ3QJQUINHYDRONE3T006GV98UQUINONE
51MO2B2OSBECABET SODIUM2K02669KWPECABET
F4ER8Z6Q3UPIVOXAZEPAM6GOW6DWN2AOXAZEPAM
LZ257RZP7KFOSPROPOFOLYI7VU623SFPROPOFOL
2U918O4BEVACRISORCIN78OY3Z0P7ZAMINACRINE