BatchFormulaBundle2Layer
type: Bundle
node role: treeRoot
id:
  v: BatchFormulaBundle2Layer
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p32
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-32p32
identifier:
  system:
    v: urn:ietf:rfc:3986
type:
  v: document
timestamp:
  v: 2024-08-29T12:34:56.789Z

urn:…
type: Composition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p32
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-32p32
text:
  status:
    v: generated
  div: Generated Narrative: Composition c00b0003-c2bf-7547-8b1c-f1f399f99d5c Profile: eCTD Batch Formula identifier: BatchFormulaComposition2layer status: Final type: m3.2.p.3.2 batch formula date: 2024-08-01 12:34:56+0000 author: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 title: Batch formula example two layer tablet
identifier:
  value:
    v: BatchFormulaComposition2layer
status:
  v: final
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/ICHContextOfUse
    code:
      v: ich_3.2.p.3.2
    display:
      v: m3.2.p.3.2 batch formula
date:
  v: 2024-08-01T12:34:56.789Z
title:
  v: Batch formula example two layer tablet
section:
  title:
    v: Batch Formula
  code:
    coding:
      system:
        v: http://terminology.hl7.org/CodeSystem/ICHContextOfUse
      code:
        v: ich_3.2.p.3.2
      display:
        v: m3.2.p.3.2 batch formula

urn:…
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization 4f3e9af1-306b-4fad-bf04-7881400b266a Profile: Basic Organization identifier: DUNS/143265222 name: Wunderwerke Contacts - Address * Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134003
      display:
        v: DUNS
  system:
    v: urn:oid:1.3.6.1.4.1.519.1
  value:
    v: 143265222
name:
  v: Wunderwerke
contact:
  address:
    type:
      v: postal
    text:
      v: Wunderwerke, 123 Scenic Road, CT, Bridgeport, USA 65478
    line:
      v: 123 Scenic Road
    city:
      v: Bridgeport
    state:
      v: CT
    postal code:
      v: 65478
    country:
      v: USA

urn:…
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization b69435a0-45c6-4d44-9fde-b354e17408d7 Profile: Basic Organization identifier: DUNS/143265222 name: Large Life Contacts - Address * 123 Broad Way, New York, NY, United States
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134003
      display:
        v: DUNS
  system:
    v: urn:oid:1.3.6.1.4.1.519.1
  value:
    v: 143265222
name:
  v: Large Life
contact:
  address:
    type:
      v: postal
    text:
      v: 123 Broad Way, New York, NY, United States
    line:
      v: 123 Broad Way
    city:
      v: New York
    state:
      v: NY
    postal code:
      v: 10020
    country:
      v: USA

urn:…
type: MedicinalProductDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-batch-formula-product
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-batch-formula-product
text:
  status:
    v: generated
  div: Generated Narrative: MedicinalProductDefinition f0f3ff35-5cfa-6617-b8f1-b8167957f53c Profile: Batch Formula Drug Product Identification identifier: ASPIRIN-ACETAMINOPHEN-Identification combinedPharmaceuticalDoseForm: TABLET, MULTILAYER route: ORAL comprisedOf: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 name productName: ASPIRIN 200mg, ACETAMINOPHEN 300mg type: Nonproprietary Name part part: ASPIRIN type: scientific name part part: 200mg type: ASPIRIN part part: ACETAMINOPHEN type: scientific name part part: 300mg type: ACETAMINOPHEN
identifier:
  value:
    v: ASPIRIN-ACETAMINOPHEN-Identification
combined pharmaceutical dose form:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C42964
    display:
      v: TABLET, MULTILAYER
route:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C38288
    display:
      v: ORAL
name:
  product name:
    v: ASPIRIN 200mg, ACETAMINOPHEN 300mg
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C96971
      display:
        v: Nonproprietary Name
  part:
    part:
      v: ASPIRIN
  part:
    part:
      v: 200mg
    type:
      text:
        v: ASPIRIN
  part:
    part:
      v: ACETAMINOPHEN
  part:
    part:
      v: 300mg
    type:
      text:
        v: ACETAMINOPHEN

urn:…
type: ManufacturedItemDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-product-batch-formula
text:
  status:
    v: extensions
  div: Generated Narrative: ManufacturedItemDefinition 8a3e11d9-4323-43c4-be00-8f0ea1837070 Profile: Drug Product Batch Formula identifier: ASPIRIN-ACETAMINOPHEN status: Active name: ASPIRIN 200mg, ACETAMINOPHEN 300mg 2000 tablets manufacturedDoseForm: Tablet manufacturer: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 property type: Batch Quantity value: 2000 tablets (Details: UCUM code{tbl} = '{tbl}') property type: Batch Utilization value: Development property type: Batch Formula Additional Information value: Makes 2000 tablets equivalent to 2.402 kilograms, accounting for losses from evaporation component type: Layer amount: 925.97 gram (Details: UCUM codeg = 'g'), 38.55 percent (Details: UCUM code% = '%') constituent amount: 400 gram (Details: UCUM codeg = 'g'), 43.1 percent (Details: UCUM code% = '%') location: Purple Layer HasIngredients - Reference * Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 constituent amount: 524.01 gram (Details: UCUM codeg = 'g'), 56.59 percent (Details: UCUM code% = '%') location: Purple Layer HasIngredients - Reference * Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 constituent amount: 203.71 gram (Details: UCUM codeg = 'g'), 22 percent (Details: UCUM code% = '%') location: Purple Layer HasIngredients - Reference * Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 constituent Overage Extension proportionDecimal: 0.02 justification: Evaporation amount: 311.68 gram (Details: UCUM codeg = 'g'), 33 percent (Details: UCUM code% = '%') location: Purple Layer HasIngredients - Reference * Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 Properties - Type Value[x] * Product Part Identifier Purple Layer…
identifier:
  value:
    v: ASPIRIN-ACETAMINOPHEN
status:
  v: active
name:
  v: ASPIRIN 200mg, ACETAMINOPHEN 300mg 2000 tablets
manufactured dose form:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C154605
    display:
      v: Tablet
property:
  type:
    text:
      v: Batch Quantity
  value: Quantity
    value:
      v: 2000
    unit:
      v: tablets
    system:
      v: http://unitsofmeasure.org
    code:
      v: {tbl}
property:
  type:
    text:
      v: Batch Utilization
  value: CodeableConcept
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C133991
      display:
        v: Development
property:
  type:
    text:
      v: Batch Formula Additional Information
  value: markdown
    v: Makes 2000 tablets equivalent to 2.402 kilograms, accounting for losses from evaporation
component:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C66831
      display:
        v: Layer
  amount:
    value:
      v: 925.97
    unit:
      v: gram
    system:
      v: http://unitsofmeasure.org
    code:
      v: g
  amount:
    value:
      v: 38.55
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
  constituent:
    amount:
      value:
        v: 400
      unit:
        v: gram
      system:
        v: http://unitsofmeasure.org
      code:
        v: g
    amount:
      value:
        v: 43.1
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
    location:
      text:
        v: Purple Layer
  constituent:
    amount:
      value:
        v: 524.01
      unit:
        v: gram
      system:
        v: http://unitsofmeasure.org
      code:
        v: g
    amount:
      value:
        v: 56.59
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
    location:
      text:
        v: Purple Layer
  constituent:
    amount:
      value:
        v: 203.71
      unit:
        v: gram
      system:
        v: http://unitsofmeasure.org
      code:
        v: g
    amount:
      value:
        v: 22
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
    location:
      text:
        v: Purple Layer
  constituent:
    extension:
      extension:
        value: decimal
      extension:
        value: markdown
      url:
        v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-overage-extension
    amount:
      value:
        v: 311.68
      unit:
        v: gram
      system:
        v: http://unitsofmeasure.org
      code:
        v: g
    amount:
      value:
        v: 33
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
    location:
      text:
        v: Purple Layer
  property:
    type:
      text:
        v: Product Part Identifier
    value: CodeableConcept
      text:
        v: Purple Layer
component:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C66831
      display:
        v: Layer
  amount:
    value:
      v: 1476.03
    unit:
      v: gram
    system:
      v: http://unitsofmeasure.org
    code:
      v: g

urn:…
type: Ingredient
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
text:
  status:
    v: generated
  div: Generated Narrative: Ingredient d4713a90-38d1-49e5-a977-78c63e518562 Profile: Drug Product Batch Formula Ingredient identifier: Asprin - Ingredient status: Active role: Active Ingredient substance Codes - Reference * Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 strength concentration: 400 gram (Details: UCUM codeg = 'g') strength concentration: 10.4 percent (Details: UCUM code% = '%')
identifier:
  value:
    v: Asprin - Ingredient
status:
  v: active
role:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C82533
    display:
      v: Active Ingredient
substance:
  strength:
    concentration: Quantity
      value:
        v: 400
      unit:
        v: gram
      system:
        v: http://unitsofmeasure.org
      code:
        v: g
  strength:
    concentration: Quantity
      value:
        v: 10.4
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: Ingredient
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
text:
  status:
    v: generated
  div: Generated Narrative: Ingredient fbd464cc-2511-4a3a-b058-3cec4fffd14f Profile: Drug Product Batch Formula Ingredient identifier: AcetaminophenIngredient status: Active role: Active Ingredient substance Codes - Reference * Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 strength concentration: 600 gram (Details: UCUM codeg = 'g') strength concentration: 25 percent (Details: UCUM code% = '%')
identifier:
  value:
    v: AcetaminophenIngredient
status:
  v: active
role:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C82533
    display:
      v: Active Ingredient
substance:
  strength:
    concentration: Quantity
      value:
        v: 600
      unit:
        v: gram
      system:
        v: http://unitsofmeasure.org
      code:
        v: g
  strength:
    concentration: Quantity
      value:
        v: 25
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: Ingredient
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
text:
  status:
    v: generated
  div: Generated Narrative: Ingredient 9973ba9a-b257-425a-8fb9-6dcfe379ca08 Profile: Drug Product Batch Formula Ingredient identifier: MaizeStarchIngredient status: Active role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 strength concentration: 1400.03 gram (Details: UCUM codeg = 'g') strength concentration: 58.28 percent (Details: UCUM code% = '%')
identifier:
  value:
    v: MaizeStarchIngredient
status:
  v: active
role:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C42637
    display:
      v: Inactive Ingredient
substance:
  strength:
    concentration: Quantity
      value:
        v: 1400.03
      unit:
        v: gram
      system:
        v: http://unitsofmeasure.org
      code:
        v: g
  strength:
    concentration: Quantity
      value:
        v: 58.28
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: Ingredient
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
text:
  status:
    v: generated
  div: Generated Narrative: Ingredient 4e394a0c-4b25-492e-aac7-0faf121ffc4f Profile: Drug Product Batch Formula Ingredient identifier: GrapeskinIngredient status: Active role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 strength concentration: 203.71 gram (Details: UCUM codeg = 'g') strength concentration: 8.48 percent (Details: UCUM code% = '%')
identifier:
  value:
    v: GrapeskinIngredient
status:
  v: active
role:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C42637
    display:
      v: Inactive Ingredient
substance:
  strength:
    concentration: Quantity
      value:
        v: 203.71
      unit:
        v: gram
      system:
        v: http://unitsofmeasure.org
      code:
        v: g
  strength:
    concentration: Quantity
      value:
        v: 8.48
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: Ingredient
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient
text:
  status:
    v: generated
  div: Generated Narrative: Ingredient 95648837-ec81-42d9-970c-eac390f2f604 Profile: Drug Product Batch Formula Ingredient identifier: WaterBFIngredient status: Active role: Inactive Ingredient substance Codes - Reference * Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 strength concentration: 50.75 kilogram (Details: UCUM codekg = 'kg') strength concentration: 95.3572 percent (Details: UCUM code% = '%')
identifier:
  value:
    v: WaterBFIngredient
status:
  v: active
role:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C42637
    display:
      v: Inactive Ingredient
substance:
  strength:
    concentration: Quantity
      value:
        v: 50.75
      unit:
        v: kilogram
      system:
        v: http://unitsofmeasure.org
      code:
        v: kg
  strength:
    concentration: Quantity
      value:
        v: 95.3572
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition cbb54715-3928-4e3f-9abe-32914f694957 Profile: Drug Substance Handle classification: Chemical grade: USP-NF manufacturer: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 Codes - Code * R16CO5Y76E Names - Name Type Preferred * ASPIRIN GSRS Preferred Term true
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C48807
    display:
      v: Chemical
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134006
    display:
      v: USP-NF
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: R16CO5Y76E
name:
  name:
    v: ASPIRIN
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition ca1ff85f-3f05-46be-8cc4-30b076d88c13 Profile: Drug Substance Handle classification: Chemical grade: USP-NF manufacturer: Bundle: identifier = UUID:49d3b79e-b436-a242-93ba-b706b4364ab2; type = document; timestamp = 2024-08-29 12:34:56+0000 Codes - Code * 362O9ITL9D Names - Name Type Preferred * ACETAMINOPHEN GSRS Preferred Term true
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C48807
    display:
      v: Chemical
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134006
    display:
      v: USP-NF
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: 362O9ITL9D
name:
  name:
    v: ACETAMINOPHEN
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition 99f4a24f-880f-45f1-8364-8e4e03977b2e Profile: Excipient Drug Substance classification: Mixture grade: Company Standard Codes - Code * O8232NY3SJ Names - Name Type Preferred * STARCH, CORN GSRS Preferred Term true SourceMaterials - Type * Chemical
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C45305
    display:
      v: Mixture
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134009
    display:
      v: Company Standard
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: O8232NY3SJ
name:
  name:
    v: STARCH, CORN
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true
source material:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C48807
      display:
        v: Chemical

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition a4624559-6c4f-4e90-996d-bc3bf2f5a3f4 Profile: Excipient Drug Substance classification: Mixture grade: BP Codes - Code * 3GOV20705G Names - Name Type Preferred * WINE GRAPE GSRS Preferred Term true SourceMaterials - Type Genus Species Part CountryOfOrigin * Plant vitis vinifera fruit skin Italy
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C45305
    display:
      v: Mixture
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C176793
    display:
      v: BP
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: 3GOV20705G
name:
  name:
    v: WINE GRAPE
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true
source material:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C14258
      display:
        v: Plant
  genus:
    text:
      v: vitis
  species:
    text:
      v: vinifera
  part:
    text:
      v: fruit skin
  country of origin:
    coding:
      system:
        v: urn:iso:std:iso:3166
      code:
        v: ITA
      display:
        v: Italy

urn:…
type: SubstanceDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient
text:
  status:
    v: generated
  div: Generated Narrative: SubstanceDefinition 254742fb-7b5b-49f5-b4af-e0d14d81f2f6 Profile: Excipient Drug Substance classification: Chemical grade: USP-NF Codes - Code * 059QF0KO0R Names - Name Type Preferred * WATER GSRS Preferred Term true SourceMaterials - Type * Chemical
classification:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C48807
    display:
      v: Chemical
grade:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134006
    display:
      v: USP-NF
code:
  code:
    coding:
      system:
        v: http://fdasis.nlm.nih.gov
      code:
        v: 059QF0KO0R
name:
  name:
    v: WATER
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C203355
      display:
        v: GSRS Preferred Term
  preferred:
    v: true
source material:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C48807
      display:
        v: Chemical

urn:…
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization 4b565cf3-5353-48af-8cd6-5ccf4e9fd579 Profile: Basic Organization identifier: DUNS/783452221, FEI/6913973 name: Manufacturing Site (J. Jones Research) Contacts - Address * Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134003
      display:
        v: DUNS
  system:
    v: urn:oid:1.3.6.1.4.1.519.1
  value:
    v: 783452221
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134004
      display:
        v: FEI
  system:
    v: urn:oid:2.16.840.1.113883.4.82
  value:
    v: 6913973
name:
  v: Manufacturing Site (J. Jones Research)
contact:
  address:
    type:
      v: postal
    text:
      v: Manufacturing Site (J. Jones Research), 444 Grant Street, Bedford, NY, United States
    line:
      v: 444 Grant Street
    city:
      v: Bedford
    state:
      v: NY
    postal code:
      v: 15600
    country:
      v: USA

urn:…
type: Organization
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-organization
text:
  status:
    v: generated
  div: Generated Narrative: Organization e165f057-5eed-4e64-8328-4438fc88fb1b Profile: Basic Organization identifier: DUNS/143265222 name: Vandechemie Contacts - Address * Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium
identifier:
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134003
      display:
        v: DUNS
  system:
    v: urn:oid:1.3.6.1.4.1.519.1
  value:
    v: 143265222
name:
  v: Vandechemie
contact:
  address:
    type:
      v: postal
    text:
      v: Vandechemie, Ruzettelaan 39234, Blankenberge, 8370, Belgium
    line:
      v: Ruzettelaan 39234
    city:
      v: Blankenberge
    postal code:
      v: 8370
    country:
      v: BEL

v: SCI

v: STR

v: SCI

v: STR

v: C203881

v: Active core/granulate

v: C203883

v: Intragranular

v: C203882

v: Extragranular

v: proportionDecimal

decimal
v: 0.02

v: justification

markdown
v: Evaporation

v: C203882

v: Extragranular

value:
  v: 61.45
unit:
  v: percent
system:
  v: http://unitsofmeasure.org
code:
  v: %

amount:
  value:
    v: 600.01
  unit:
    v: gram
  system:
    v: http://unitsofmeasure.org
  code:
    v: g
amount:
  value:
    v: 40.65
  unit:
    v: percent
  system:
    v: http://unitsofmeasure.org
  code:
    v: %
location:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C203881
    display:
      v: Active core/granulate
  text:
    v: Example1Drug_LayerB

amount:
  value:
    v: 876.02
  unit:
    v: gram
  system:
    v: http://unitsofmeasure.org
  code:
    v: g
amount:
  value:
    v: 59.35
  unit:
    v: percent
  system:
    v: http://unitsofmeasure.org
  code:
    v: %
location:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C203883
    display:
      v: Intragranular
  text:
    v: Example1Drug_LayerB

amount:
  value:
    v: 369.01
  unit:
    v: gram
  system:
    v: http://unitsofmeasure.org
  code:
    v: g
amount:
  value:
    v: 25
  unit:
    v: percent
  system:
    v: http://unitsofmeasure.org
  code:
    v: %
location:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C203882
    display:
      v: Extragranular
  text:
    v: Example1Drug_LayerB

type:
  text:
    v: Product Part Identifier
value: CodeableConcept
  text:
    v: Example1Drug_LayerB