SpecificationProductBundle
type: Bundle
node role: treeRoot
id:
  v: SpecificationProductBundle
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/cmc-ectd-document-sp4151
identifier:
  system:
    v: urn:ietf:rfc:3986
type:
  v: document
timestamp:
  v: 2023-12-15T22:33:13.089Z

urn:…
type: Composition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/ectd-composition-sp4151
text:
  status:
    v: generated
  div: Generated Narrative: Composition d332acdf-4874-407b-9950-528f14c6bea2 Profile: eCTD Specification identifier: ExampleSpecification status: Final type: m3.2.p.5.1 specification(s) date: 2023-12-15 22:33:13+0000 author: Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000 title: Quality Specification for an example Drug Product
identifier:
  value:
    v: ExampleSpecification
status:
  v: final
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/ICHContextOfUse
    code:
      v: ich_3.2.p.5.1
    display:
      v: m3.2.p.5.1 specification(s)
date:
  v: 2023-12-15T22:33:13.089Z
title:
  v: Quality Specification for an example Drug Product
section:
  title:
    v: 32P51

urn:…
type: PlanDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-quality-specification
text:
  status:
    v: extensions
  div: Id: aa514363-d43f-4052-b44e-b67aa4d6dee7 Version: 1.0 ExampleSpecification Title: Quality Specification for OXAZEPAM Type: system: http://terminology.hl7.org/CodeSystem/plan-definition-type code: workflow-definition display: Workflow Definition system: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl code: C134021 display: Drug Product Subject: reference: urn:uuid:89676a69-1fe7-422c-ab00-92abe4ef6ea9 Date: 2022-12-08 Actions: Single Stage Spectrophotometry Identification: Alternate Single Stage Identity - Ferric Chloride: Alternate Single Stage Loss on Drying: Single Stage Readily Carbonizable Sub: Single Stage Residue on ignition (Ash): Single Stage Substances insoluble in sodium carbonate TS: Single Stage Impurities - Chloride (Cl): Single Stage Impurities - Sulfate (SO4): Single Stage Elemental Impurities - Limits: Single Stage Limit of Free Salicylic Acid: Single Stage Organic Volatile Impurities: Single Stage Assay Dry Basis: Dissolution - 30 minute: Then: Stage 1 : Stage 2 : Stage 3 :
extension:
  url:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-specification-status-extension
  value: CodeableConcept
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134011
      display:
        v: Not Approved
identifier:
  value:
    v: ExampleSpecification
version:
  v: 1.0
title:
  v: Quality Specification for OXAZEPAM
type:
  coding:
    system:
      v: http://terminology.hl7.org/CodeSystem/plan-definition-type
    code:
      v: workflow-definition
    display:
      v: Workflow Definition
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134021
    display:
      v: Drug Product
status:
  v: active
subject: Reference
date:
  v: 2022-12-08
goal:
  description:
    text:
      v: Average of 10 between 2-3 pH
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134030
      display:
        v: Stability
  target:
    modifier extension:
      extension:
        value: Quantity
      extension:
        value: Quantity
      url:
        v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range
goal:
  description:
    text:
      v: Maxima only at the same wavelengths compared to reference standard
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134030
      display:
        v: Stability
  target:
    detail: string
      v: Conforms
goal:
  description:
    text:
      v: <= 0.5 %
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134030
      display:
        v: Stability
  target:
    detail: Quantity
      value:
        v: 0.5
      comparator:
        v: <=
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
goal:
  description:
    text:
      v: Color of solution is clear
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134030
      display:
        v: Stability
  target:
    detail: string
      v: Conforms
goal:
  description:
    text:
      v: <= 0.05 %
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134030
      display:
        v: Stability
  target:
    detail: Quantity
      value:
        v: 0.05
      comparator:
        v: <=
      unit:
        v: percent
      system:
        v: http://unitsofmeasure.org
      code:
        v: %
goal:
  description:
    text:
      v: No Particulate Matter detected
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134029
      display:
        v: Release
  addresses:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C134030

urn:…
type: MedicinalProductDefinition
meta:
  profile:
    v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-handle
    link: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-drug-product-handle
text:
  status:
    v: generated
  div: Generated Narrative: MedicinalProductDefinition 89676a69-1fe7-422c-ab00-92abe4ef6ea9 Profile: Drug Product Handle identifier: Example2BeadDrug combinedPharmaceuticalDoseForm: CAPSULE route: ORAL name productName: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg type: Non-Proprietary part part: OXAZEPAM type: scientific name part part: 30mg type: OXAZEPAM part part: PROPRANOLOL HYDROCHLORIDE type: scientific name part part: 60mg type: PROPRANOLOL HYDROCHLORIDE
identifier:
  value:
    v: Example2BeadDrug
combined pharmaceutical dose form:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C25158
    display:
      v: CAPSULE
route:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C38288
    display:
      v: ORAL
name:
  product name:
    v: OXAZEPAM 30mg, PROPRANOLOL HYDROCHLORIDE 60mg
  type:
    coding:
      system:
        v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
      code:
        v: C96971
      display:
        v: Nonproprietary Name
    text:
      v: Non-Proprietary
  part:
    part:
      v: OXAZEPAM
  part:
    part:
      v: 30mg
    type:
      text:
        v: OXAZEPAM
  part:
    part:
      v: PROPRANOLOL HYDROCHLORIDE
  part:
    part:
      v: 60mg
    type:
      text:
        v: PROPRANOLOL HYDROCHLORIDE

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

v: low

Quantity
value:
  v: 2
comparator:
  v: >=
unit:
  v: [pH]
system:
  v: http://unitsofmeasure.org
code:
  v: [pH]

v: high

Quantity
value:
  v: 3
comparator:
  v: <
unit:
  v: [pH]
system:
  v: http://unitsofmeasure.org
code:
  v: [pH]

v: Stability

detail: string
  v: pass

description:
  text:
    v: <= 0.014 %
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134030
    display:
      v: Stability
target:
  detail: Quantity
    value:
      v: 0.014
    comparator:
      v: <=
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %

description:
  text:
    v: <= 0.04 %
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134030
    display:
      v: Stability
target:
  detail: Quantity
    value:
      v: 0.04
    comparator:
      v: <=
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %

description:
  text:
    v: <= 0.001 %
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134030
    display:
      v: Stability
target:
  detail: Quantity
    value:
      v: 0.001
    comparator:
      v: <=
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %

description:
  text:
    v: Color intenssity of feriric ammonium sulfate TS is not less that than salicylic acid (0.1%) solution
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134030
    display:
      v: Stability
target:
  detail: string
    v: pass

description:
  text:
    v: Ethanol < 0.2%
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134030
    display:
      v: Stability
target:
  measure:
    text:
      v: Ethanol
  detail: Quantity
    value:
      v: 0.2
    comparator:
      v: <=
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %

description:
  text:
    v: Ethyl Ether < 0.1%
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
target:
  measure:
    text:
      v: Ethyl Ether
  detail: Quantity
    value:
      v: 0.1
    comparator:
      v: <=
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %

description:
  text:
    v: 1—propanol < 0.15%
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
target:
  measure:
    text:
      v: 1—propanol
  detail: Quantity
    value:
      v: 0.15
    comparator:
      v: <=
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %

description:
  text:
    v: Total < 0.5%
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
target:
  measure:
    text:
      v: Total Residual Solvents
  detail: Quantity
    value:
      v: 0.5
    comparator:
      v: <=
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %

description:
  text:
    v: 99.5 - 100.5 %
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134030
    display:
      v: Stability
target:
  modifier extension:
    extension:
      url:
        v: low
      value: Quantity
    extension:
      url:
        v: high
      value: Quantity
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-target-range

v: 99.5

v: >=

v: percent

v: %

v: 100.5

v: <=

v: percent

v: %

description:
  text:
    v: n=6
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
target:
  detail: integer
    v: 6

description:
  text:
    v: Each unit is NLT Q + 5%
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
target:
  detail: Quantity
    value:
      v: 85
    comparator:
      v: <=
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %

description:
  text:
    v: n=6
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
target:
  detail: integer
    v: 6

description:
  text:
    v: Average of 12 units (S1 + S2) is equal to or greater than Q and no unit is less than Q - 15%
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
target:
  measure:
    text:
      v: Average of 12 units
  detail: Quantity
    value:
      v: 80
    comparator:
      v: <=
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
target:
  measure:
    text:
      v: unit
  detail: Quantity
    value:
      v: 65
    comparator:
      v: <=
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %

description:
  text:
    v: Average of 24 units (S1 + S2 + S3) is equal to or greater than Q, not more than 2 units are less than Q - 15%, no unit is less than Q - 25%
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
target:
  measure:
    text:
      v: Average of 24 units
  detail: Quantity
    value:
      v: 80
    comparator:
      v: <=
    unit:
      v: percent
    system:
      v: http://unitsofmeasure.org
    code:
      v: %
target:
  measure:
    text:
      v: units less than Q - 15%
  detail: Quantity
    value:
      v: 2
    comparator:
      v: <=
    unit:
      v: Amb a 1 units
    system:
      v: http://unitsofmeasure.org
    code:
      v: [Amb'a'1'U]
target:
  measure:
    text:
      v: units less than Q - 25%
  detail: Quantity
    value:
      v: 0
    comparator:
      v: <=
    unit:
      v: Amb a 1 units
    system:
      v: http://unitsofmeasure.org
    code:
      v: [Amb'a'1'U]

description:
  text:
    v: n=12
addresses:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134029
    display:
      v: Release
target:
  detail: integer
    v: 12

prefix:
  v: Single Stage
title:
  v: Spectrophotometry Identification
description:
  v: Alternate
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96102
    display:
      v: Compendial
  text:
    v: Spectrophotometry
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C138993
    display:
      v: Identification
documentation:
  type:
    v: documentation
  label:
    v: USP <197>
related action:
  relationship:
    v: concurrent

prefix:
  v: Single Stage
title:
  v: Identity - Ferric Chloride
description:
  v: Alternate
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96103
    display:
      v: Proprietary
  text:
    v: HPLC
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C138993
    display:
      v: Identification
documentation:
  type:
    v: documentation
  label:
    v: EX-TEST-01
related action:
  relationship:
    v: concurrent

prefix:
  v: Single Stage
title:
  v: Loss on Drying
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96102
    display:
      v: Compendial
  text:
    v: Visual
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134255
    display:
      v: Loss on Drying
documentation:
  type:
    v: documentation
  label:
    v: USP <731>

prefix:
  v: Single Stage
title:
  v: Readily Carbonizable Sub
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96102
    display:
      v: Compendial
  text:
    v: Visual
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C205026
    display:
      v: Organoleptic
reason:
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      v: 2
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    code:
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    display:
      v: Color of Solution
documentation:
  type:
    v: documentation
  label:
    v: USP <271>

prefix:
  v: Single Stage
title:
  v: Residue on ignition (Ash)
code:
  coding:
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      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
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    display:
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reason:
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    code:
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    display:
      v: Residue on Ignition
documentation:
  type:
    v: documentation
  label:
    v: USP <281>

prefix:
  v: Single Stage
title:
  v: Substances insoluble in sodium carbonate TS
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96103
    display:
      v: Proprietary
  text:
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reason:
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      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C193381
    display:
      v: Foreign and Particulate Matter
documentation:
  type:
    v: documentation
  label:
    v: EX-TEST-02

prefix:
  v: Single Stage
title:
  v: Impurities - Chloride (Cl)
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96102
    display:
      v: Compendial
  text:
    v: FTIR
reason:
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      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C204971
    display:
      v: Impurity
reason:
  extension:
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      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 2
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C205039
    display:
      v: Specified Identified Impurity
documentation:
  type:
    v: documentation
  label:
    v: USP <221>

prefix:
  v: Single Stage
title:
  v: Impurities - Sulfate (SO4)
code:
  coding:
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      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96102
    display:
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  text:
    v: FTIR
reason:
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    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C204971
    display:
      v: Impurity
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 2
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C205039
    display:
      v: Specified Identified Impurity
documentation:
  type:
    v: documentation
  label:
    v: USP <221>

prefix:
  v: Single Stage
title:
  v: Elemental Impurities - Limits
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96102
    display:
      v: Compendial
  text:
    v: UV
reason:
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      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C204971
    display:
      v: Impurity
reason:
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      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 2
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C205014
    display:
      v: Elemental Impurity
documentation:
  type:
    v: documentation
  label:
    v: USP <231>

prefix:
  v: Single Stage
title:
  v: Limit of Free Salicylic Acid
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96103
    display:
      v: Proprietary
  text:
    v: Titration
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C204971
    display:
      v: Impurity
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 2
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134254
    display:
      v: Impurities/Degradation Products/Related Substances
documentation:
  type:
    v: documentation
  label:
    v: EX-TEST-03

prefix:
  v: Single Stage
title:
  v: Organic Volatile Impurities
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96102
    display:
      v: Compendial
  text:
    v: Visual
reason:
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      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C204971
    display:
      v: Impurity
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 2
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134002
    display:
      v: Residual Solvent
documentation:
  type:
    v: documentation
  label:
    v: USP <467>

prefix:
  v: Single Stage
title:
  v: Assay Dry Basis
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96103
    display:
      v: Proprietary
  text:
    v: Visual
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C60819
    display:
      v: Assay
reason:
  extension:
    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 2
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C204845
    display:
      v: Active Ingredient Content
documentation:
  type:
    v: documentation
  label:
    v: EX-TEST-04

title:
  v: Dissolution - 30 minute
code:
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C96103
    display:
      v: Proprietary
  text:
    v: Visual
reason:
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    url:
      v: http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pq-hierarchical-level-extension
    value: positiveInt
      v: 1
  coding:
    system:
      v: http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl
    code:
      v: C134253
    display:
      v: Dissolution
documentation:
  type:
    v: documentation
  label:
    v: EX-TEST-05
action:
  prefix:
    v: Stage 1
action:
  prefix:
    v: Stage 2
action:
  prefix:
    v: Stage 3

v: SCI

v: STR

v: SCI

v: STR