Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
1.0.0-ballot - STU 1-ballot
This page is part of the Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA (v1.0.0-ballot: STU1 Ballot 1) based on FHIR (HL7® FHIR® Standard) v5.0.0. . For a full list of available versions, see the Directory of published versions
Generated Narrative: ManufacturedItemDefinition
Resource ManufacturedItemDefinition "a8316fc9-8ca8-4115-81c1-9f8f84c99149"
Profile: Manufactured Drug Product
identifier: Example1Drug
status: draft
manufacturedDoseForm: Tablet Dosage Form Category (PQ-CMC-FDA Temporary Codes#C154605)
property
type: Product Overall Release Profile (PQ-CMC-FDA Temporary Codes#OvrRelsProf)
value: Extended-Release Profile (PQ-CMC-FDA Temporary Codes#C42713)
property
type: Product Schematic (PQ-CMC-FDA Temporary Codes#Schematic)
value:
property
type: Product Weight Type (PQ-CMC-FDA Temporary Codes#WgtTyp)
value: Mass (PQ-CMC-FDA Temporary Codes#C168628)
property
type: Product Total Weight Numeric Numerator (PQ-CMC-FDA Temporary Codes#TotWgtNum)
value: 1201 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')
property
type: Quality Standard (PQ-CMC-FDA Temporary Codes#QualStd)
value: USP-NF (PQ-CMC-FDA Temporary Codes#C134006)
property
type: Product Overall Release Mechanism (PQ-CMC-FDA Temporary Codes#OvrRelsMech)
value: Matrix (PQ-CMC-FDA Temporary Codes#C203359)
property
type: Coating Indicator (PQ-CMC-FDA Temporary Codes#CoatInd)
value: false
property
type: Tablet Layer Count (PQ-CMC-FDA Temporary Codes#TabLayCnt)
value: 2
property
type: Tablet Bead Type Count (PQ-CMC-FDA Temporary Codes#BeaTypCnt)
value: 0
property
type: Product Total Weight Numeric Denominator (PQ-CMC-FDA Temporary Codes#TotWgtDen)
value: 1 1 (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C66832 = '1*')
component
type: Layer (PQ-CMC-FDA Temporary Codes#C66831)
amount: 463 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')
constituent
Content Percent: 0.4319
amount: 200 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')
location: Purple Layer (PQ-CMC-FDA Temporary Codes#C203881 "Active core/granulate")
function: Active Ingredient (PQ-CMC-FDA Temporary Codes#C82533)
HasIngredients
Reference urn:uuid:fc09842a-8f71-48f2-9f9f-ff2441b2eb6f constituent
Content Percent: 0.5659
amount: 262 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')
location: Purple Layer (PQ-CMC-FDA Temporary Codes#C203883 "Intragranular")
function: Inactive Ingredient (PQ-CMC-FDA Temporary Codes#C42637), Filler Excipient (PQ-CMC-FDA Temporary Codes#C42650)
HasIngredients
Reference urn:uuid:d01421cc-6488-468b-a676-d3e7281875e2 constituent
Content Percent: 0.0022
amount: 1 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')
location: Purple Layer (PQ-CMC-FDA Temporary Codes#C203883 "Intragranular")
function: Inactive Ingredient (PQ-CMC-FDA Temporary Codes#C42637), Color Excipient (PQ-CMC-FDA Temporary Codes#C42656)
HasIngredients
Reference urn:uuid:3791c4ce-2b43-4d7b-b195-0e5f88f28dab Properties
Type Value[x] Product Part Identifier (PQ-CMC-FDA Temporary Codes#PPiD) Example1Drug_LayerA () Product Part Release Profile (PQ-CMC-FDA Temporary Codes#RelsProf) Delayed-Release Profile (PQ-CMC-FDA Temporary Codes#C42730) Product Part Content Percent (PQ-CMC-FDA Temporary Codes#ContPercent) 0.3855 Product Part Color Description (PQ-CMC-FDA Temporary Codes#Color) Purple ()
component
type: Layer (PQ-CMC-FDA Temporary Codes#C66831)
amount: 738 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')
constituent
Content Percent: 0.4065
amount: 300 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')
location: White Layer (PQ-CMC-FDA Temporary Codes#C203881 "Active core/granulate")
function: Active Ingredient (PQ-CMC-FDA Temporary Codes#C82533)
HasIngredients
Reference urn:uuid:7f10a35e-228d-42db-8918-6ccada78454d constituent
Content Percent: 0.5935
amount: 438 mg (Details: http://hl7.org/fhir/us/pq-cmc-fda/CodeSystem/cmc-ncit-dummy code C28253 = 'mg')
location: White Layer (PQ-CMC-FDA Temporary Codes#C203883 "Intragranular")
function: Inactive Ingredient (PQ-CMC-FDA Temporary Codes#C42637), Filler Excipient (PQ-CMC-FDA Temporary Codes#C42650)
HasIngredients
Reference urn:uuid:d01421cc-6488-468b-a676-d3e7281875e2 Properties
Type Value[x] Product Part Identifier (PQ-CMC-FDA Temporary Codes#PPiD) Example1Drug_LayerB () Product Part Release Profile (PQ-CMC-FDA Temporary Codes#RelsProf) Delayed-Release Profile (PQ-CMC-FDA Temporary Codes#C42730) Product Part Content Percent (PQ-CMC-FDA Temporary Codes#ContPercent) 0.6145 Product Part Color Description (PQ-CMC-FDA Temporary Codes#Color) White ()
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#1.0.0-ballot based on FHIR 5.0.0. Generated 2024-04-08
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