Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA
2.0.0-ballot - STU2 ballot
Pharmaceutical Quality - Chemistry, Manufacturing and Controls (PQ-CMC) Submissions to FDA, published by HL7 International / Biomedical Research and Regulation. This guide is not an authorized publication; it is the continuous build for version 2.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/FHIR-us-pq-cmc-fda/ and changes regularly. See the Directory of published versions
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"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"MedicinalProductDefinition_d0d2df25-5cfa-4417-b8d1-b8147957f53c\"> </a><p class=\"res-header-id\"><b>Generated Narrative: MedicinalProductDefinition d0d2df25-5cfa-4417-b8d1-b8147957f53c</b></p><a name=\"d0d2df25-5cfa-4417-b8d1-b8147957f53c\"> </a><a name=\"hcd0d2df25-5cfa-4417-b8d1-b8147957f53c\"> </a><a name=\"d0d2df25-5cfa-4417-b8d1-b8147957f53c-en-US\"> </a><p><b>identifier</b>: Oxazepam-Propranolol-BatchFormula-Identification</p><p><b>combinedPharmaceuticalDoseForm</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42953}\">LIQUID</span></p><p><b>route</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C38288}\">ORAL</span></p><p><b>comprisedOf</b>: <a href=\"Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-249ef22b-d521-4304-a388-6b9035f97b22\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></p><blockquote><p><b>name</b></p><p><b>productName</b>: ATOMOXETINE HYDROCHLORIDE 1mg</p><p><b>type</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C96971}\">Nonproprietary Name</span></p><blockquote><p><b>part</b></p><p><b>part</b>: ATOMOXETINE HYDROCHLORIDE</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 SCI}\">scientific name</span></p></blockquote><blockquote><p><b>part</b></p><p><b>part</b>: 1mg</p><p><b>type</b>: <span title=\"Codes:{http://terminology.hl7.org/CodeSystem/v3-EntityNamePartQualifierR2 STR}\">ATOMOXETINE HYDROCHLORIDE</span></p></blockquote></blockquote></div>"
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{
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type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 20.5 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span>, 0.0385 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p><h3>HasIngredients</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-12cce82f-8595-4860-b7ca-06c9ec0327f2\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 5 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span>, 0.0094 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p><h3>HasIngredients</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-45eb4f05-83d9-4819-bb60-96c7c5ce2b76\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 2.27 kilogram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codekg = 'kg')</span>, 4.2652 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p><h3>HasIngredients</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-29c0ee76-f62f-41d3-b761-73d5f205e552\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 150 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span>, 0.2818 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p><h3>HasIngredients</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-44fad9fd-826a-4f0c-9f25-e0a78d1c4269\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><blockquote><p><b>constituent</b></p><p><b>amount</b>: 50.75 kilogram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codekg = 'kg')</span>, 95.3572 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p><h3>HasIngredients</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-d0574580-7694-4a36-8a27-5bdbccfc5557\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table></blockquote><h3>Properties</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td><td><b>Value[x]</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:\">Product Part Identifier</span></td><td><span title=\"Codes:\">solution</span></td></tr></table></blockquote></div>"
},
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{
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{
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{
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"property" : [
{
"type" : {
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"unit" : "liter",
"system" : "http://unitsofmeasure.org",
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{
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"valueCodeableConcept" : {
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{
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"code" : "C133990",
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}
},
{
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},
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}
],
"component" : [
{
"type" : {
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{
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"unit" : "kilogram",
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{
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"unit" : "percent",
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],
"constituent" : [
{
"extension" : [
{
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],
"amount" : [
{
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"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
},
{
"value" : 0.0477,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
],
"hasIngredient" : [
{
"reference" : {
"reference" : "urn:uuid:1c1a2a23-1fd7-4487-9682-49877f9f9f77"
}
}
]
},
{
"amount" : [
{
"value" : 20.5,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
},
{
"value" : 0.0385,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
],
"hasIngredient" : [
{
"reference" : {
"reference" : "urn:uuid:12cce82f-8595-4860-b7ca-06c9ec0327f2"
}
}
]
},
{
"amount" : [
{
"value" : 5,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
},
{
"value" : 0.0094,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
],
"hasIngredient" : [
{
"reference" : {
"reference" : "urn:uuid:45eb4f05-83d9-4819-bb60-96c7c5ce2b76"
}
}
]
},
{
"amount" : [
{
"value" : 2.27,
"unit" : "kilogram",
"system" : "http://unitsofmeasure.org",
"code" : "kg"
},
{
"value" : 4.2652,
"unit" : "percent",
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"code" : "%"
}
],
"hasIngredient" : [
{
"reference" : {
"reference" : "urn:uuid:29c0ee76-f62f-41d3-b761-73d5f205e552"
}
}
]
},
{
"amount" : [
{
"value" : 150,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
},
{
"value" : 0.2818,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
],
"hasIngredient" : [
{
"reference" : {
"reference" : "urn:uuid:44fad9fd-826a-4f0c-9f25-e0a78d1c4269"
}
}
]
},
{
"amount" : [
{
"value" : 50.75,
"unit" : "kilogram",
"system" : "http://unitsofmeasure.org",
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},
{
"value" : 95.3572,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
],
"hasIngredient" : [
{
"reference" : {
"reference" : "urn:uuid:d0574580-7694-4a36-8a27-5bdbccfc5557"
}
}
]
}
],
"property" : [
{
"type" : {
"text" : "Product Part Identifier"
},
"valueCodeableConcept" : {
"text" : "solution"
}
}
]
}
]
}
},
{
"fullUrl" : "urn:uuid:1c1a2a23-1fd7-4487-9682-49877f9f9f77",
"resource" : {
"resourceType" : "Ingredient",
"id" : "1c1a2a23-1fd7-4487-9682-49877f9f9f77",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_1c1a2a23-1fd7-4487-9682-49877f9f9f77\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient 1c1a2a23-1fd7-4487-9682-49877f9f9f77</b></p><a name=\"1c1a2a23-1fd7-4487-9682-49877f9f9f77\"> </a><a name=\"hc1c1a2a23-1fd7-4487-9682-49877f9f9f77\"> </a><a name=\"1c1a2a23-1fd7-4487-9682-49877f9f9f77-en-US\"> </a><p><b>identifier</b>: AtomexetineHydrochlorideBFIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C82533}\">Active Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-717d868e-6696-4ebb-adf4-63eadb3bf058\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 25.42 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 0.0477 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>"
},
"identifier" : {
"value" : "AtomexetineHydrochlorideBFIngredient"
},
"status" : "active",
"role" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C82533",
"display" : "Active Ingredient"
}
]
},
"substance" : {
"code" : {
"reference" : {
"reference" : "urn:uuid:717d868e-6696-4ebb-adf4-63eadb3bf058"
}
},
"strength" : [
{
"concentrationQuantity" : {
"value" : 25.42,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
}
},
{
"concentrationQuantity" : {
"value" : 0.0477,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
]
}
}
},
{
"fullUrl" : "urn:uuid:717d868e-6696-4ebb-adf4-63eadb3bf058",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "717d868e-6696-4ebb-adf4-63eadb3bf058",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-routine-drug-substance"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_717d868e-6696-4ebb-adf4-63eadb3bf058\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 717d868e-6696-4ebb-adf4-63eadb3bf058</b></p><a name=\"717d868e-6696-4ebb-adf4-63eadb3bf058\"> </a><a name=\"hc717d868e-6696-4ebb-adf4-63eadb3bf058\"> </a><a name=\"717d868e-6696-4ebb-adf4-63eadb3bf058-en-US\"> </a><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}\">USP-NF</span></p><p><b>manufacturer</b>: <a href=\"Bundle-30536c0e-456c-4f90-9f02-da7be1d289e9.html#urn-uuid-e875ef93-a730-4c44-bead-53663ae7f501\">Bundle: identifier = UUID:1bf43677-1c61-41dd-93c2-8ec7f327d0f1; type = document; timestamp = 2023-12-15 22:19:47+0000</a></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov 57WVB6I2W0}\">57WVB6I2W0</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>ATOMOXETINE HYDROCHLORIDE</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table></div>"
},
"classification" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
],
"grade" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134006",
"display" : "USP-NF"
}
]
}
],
"manufacturer" : [
{
"reference" : "urn:uuid:e875ef93-a730-4c44-bead-53663ae7f501"
}
],
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "57WVB6I2W0"
}
]
}
}
],
"name" : [
{
"name" : "ATOMOXETINE HYDROCHLORIDE",
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
}
]
}
},
{
"fullUrl" : "urn:uuid:12cce82f-8595-4860-b7ca-06c9ec0327f2",
"resource" : {
"resourceType" : "Ingredient",
"id" : "12cce82f-8595-4860-b7ca-06c9ec0327f2",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_12cce82f-8595-4860-b7ca-06c9ec0327f2\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient 12cce82f-8595-4860-b7ca-06c9ec0327f2</b></p><a name=\"12cce82f-8595-4860-b7ca-06c9ec0327f2\"> </a><a name=\"hc12cce82f-8595-4860-b7ca-06c9ec0327f2\"> </a><a name=\"12cce82f-8595-4860-b7ca-06c9ec0327f2-en-US\"> </a><p><b>identifier</b>: GlacialAceticAcidBFIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}\">Inactive Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-45942749-64db-4f91-88c3-51adb680fed1\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 20.5 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 0.0385 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>"
},
"identifier" : {
"value" : "GlacialAceticAcidBFIngredient"
},
"status" : "active",
"role" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C42637",
"display" : "Inactive Ingredient"
}
]
},
"substance" : {
"code" : {
"reference" : {
"reference" : "urn:uuid:45942749-64db-4f91-88c3-51adb680fed1"
}
},
"strength" : [
{
"concentrationQuantity" : {
"value" : 20.5,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
}
},
{
"concentrationQuantity" : {
"value" : 0.0385,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
]
}
}
},
{
"fullUrl" : "urn:uuid:45942749-64db-4f91-88c3-51adb680fed1",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "45942749-64db-4f91-88c3-51adb680fed1",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_45942749-64db-4f91-88c3-51adb680fed1\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 45942749-64db-4f91-88c3-51adb680fed1</b></p><a name=\"45942749-64db-4f91-88c3-51adb680fed1\"> </a><a name=\"hc45942749-64db-4f91-88c3-51adb680fed1\"> </a><a name=\"45942749-64db-4f91-88c3-51adb680fed1-en-US\"> </a><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}\">USP-NF</span></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov Q40Q9N063P}\">Q40Q9N063P</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>ACETIC ACID</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></td></tr></table></div>"
},
"classification" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
],
"grade" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134006",
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}
]
}
],
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "Q40Q9N063P"
}
]
}
}
],
"name" : [
{
"name" : "ACETIC ACID",
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
}
],
"sourceMaterial" : {
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
}
}
},
{
"fullUrl" : "urn:uuid:45eb4f05-83d9-4819-bb60-96c7c5ce2b76",
"resource" : {
"resourceType" : "Ingredient",
"id" : "45eb4f05-83d9-4819-bb60-96c7c5ce2b76",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_45eb4f05-83d9-4819-bb60-96c7c5ce2b76\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient 45eb4f05-83d9-4819-bb60-96c7c5ce2b76</b></p><a name=\"45eb4f05-83d9-4819-bb60-96c7c5ce2b76\"> </a><a name=\"hc45eb4f05-83d9-4819-bb60-96c7c5ce2b76\"> </a><a name=\"45eb4f05-83d9-4819-bb60-96c7c5ce2b76-en-US\"> </a><p><b>identifier</b>: AnhydrousSodiumAcetateBFIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}\">Inactive Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-07c598ee-3dcf-45b7-b4e5-b24812c22aff\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 5 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 0.0094 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>"
},
"identifier" : {
"value" : "AnhydrousSodiumAcetateBFIngredient"
},
"status" : "active",
"role" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C42637",
"display" : "Inactive Ingredient"
}
]
},
"substance" : {
"code" : {
"reference" : {
"reference" : "urn:uuid:07c598ee-3dcf-45b7-b4e5-b24812c22aff"
}
},
"strength" : [
{
"concentrationQuantity" : {
"value" : 5,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
}
},
{
"concentrationQuantity" : {
"value" : 0.0094,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
]
}
}
},
{
"fullUrl" : "urn:uuid:07c598ee-3dcf-45b7-b4e5-b24812c22aff",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "07c598ee-3dcf-45b7-b4e5-b24812c22aff",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_07c598ee-3dcf-45b7-b4e5-b24812c22aff\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition 07c598ee-3dcf-45b7-b4e5-b24812c22aff</b></p><a name=\"07c598ee-3dcf-45b7-b4e5-b24812c22aff\"> </a><a name=\"hc07c598ee-3dcf-45b7-b4e5-b24812c22aff\"> </a><a name=\"07c598ee-3dcf-45b7-b4e5-b24812c22aff-en-US\"> </a><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}\">USP-NF</span></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov NVG71ZZ7P0}\">NVG71ZZ7P0</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>SODIUM ACETATE ANHYDROUS</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></td></tr></table></div>"
},
"classification" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
],
"grade" : [
{
"coding" : [
{
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"code" : "C134006",
"display" : "USP-NF"
}
]
}
],
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "NVG71ZZ7P0"
}
]
}
}
],
"name" : [
{
"name" : "SODIUM ACETATE ANHYDROUS",
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
}
],
"sourceMaterial" : {
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
}
}
},
{
"fullUrl" : "urn:uuid:29c0ee76-f62f-41d3-b761-73d5f205e552",
"resource" : {
"resourceType" : "Ingredient",
"id" : "29c0ee76-f62f-41d3-b761-73d5f205e552",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_29c0ee76-f62f-41d3-b761-73d5f205e552\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient 29c0ee76-f62f-41d3-b761-73d5f205e552</b></p><a name=\"29c0ee76-f62f-41d3-b761-73d5f205e552\"> </a><a name=\"hc29c0ee76-f62f-41d3-b761-73d5f205e552\"> </a><a name=\"29c0ee76-f62f-41d3-b761-73d5f205e552-en-US\"> </a><p><b>identifier</b>: MannitolBFIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}\">Inactive Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-a339a562-e325-4ce6-a830-d25c27b5e2da\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 2.27 kilogram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codekg = 'kg')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 4.2652 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>"
},
"identifier" : {
"value" : "MannitolBFIngredient"
},
"status" : "active",
"role" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C42637",
"display" : "Inactive Ingredient"
}
]
},
"substance" : {
"code" : {
"reference" : {
"reference" : "urn:uuid:a339a562-e325-4ce6-a830-d25c27b5e2da"
}
},
"strength" : [
{
"concentrationQuantity" : {
"value" : 2.27,
"unit" : "kilogram",
"system" : "http://unitsofmeasure.org",
"code" : "kg"
}
},
{
"concentrationQuantity" : {
"value" : 4.2652,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
]
}
}
},
{
"fullUrl" : "urn:uuid:a339a562-e325-4ce6-a830-d25c27b5e2da",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "a339a562-e325-4ce6-a830-d25c27b5e2da",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_a339a562-e325-4ce6-a830-d25c27b5e2da\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition a339a562-e325-4ce6-a830-d25c27b5e2da</b></p><a name=\"a339a562-e325-4ce6-a830-d25c27b5e2da\"> </a><a name=\"hca339a562-e325-4ce6-a830-d25c27b5e2da\"> </a><a name=\"a339a562-e325-4ce6-a830-d25c27b5e2da-en-US\"> </a><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}\">USP-NF</span></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov 3OWL53L36A}\">3OWL53L36A</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>MANNITOL</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></td></tr></table></div>"
},
"classification" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
],
"grade" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134006",
"display" : "USP-NF"
}
]
}
],
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "3OWL53L36A"
}
]
}
}
],
"name" : [
{
"name" : "MANNITOL",
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
}
],
"sourceMaterial" : {
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
}
}
},
{
"fullUrl" : "urn:uuid:44fad9fd-826a-4f0c-9f25-e0a78d1c4269",
"resource" : {
"resourceType" : "Ingredient",
"id" : "44fad9fd-826a-4f0c-9f25-e0a78d1c4269",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_44fad9fd-826a-4f0c-9f25-e0a78d1c4269\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient 44fad9fd-826a-4f0c-9f25-e0a78d1c4269</b></p><a name=\"44fad9fd-826a-4f0c-9f25-e0a78d1c4269\"> </a><a name=\"hc44fad9fd-826a-4f0c-9f25-e0a78d1c4269\"> </a><a name=\"44fad9fd-826a-4f0c-9f25-e0a78d1c4269-en-US\"> </a><p><b>identifier</b>: MetacresolBFIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}\">Inactive Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-c75df5fb-e962-43a6-9dd3-c6682da10a7e\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 150 gram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codeg = 'g')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 0.2818 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>"
},
"identifier" : {
"value" : "MetacresolBFIngredient"
},
"status" : "active",
"role" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C42637",
"display" : "Inactive Ingredient"
}
]
},
"substance" : {
"code" : {
"reference" : {
"reference" : "urn:uuid:c75df5fb-e962-43a6-9dd3-c6682da10a7e"
}
},
"strength" : [
{
"concentrationQuantity" : {
"value" : 150,
"unit" : "gram",
"system" : "http://unitsofmeasure.org",
"code" : "g"
}
},
{
"concentrationQuantity" : {
"value" : 0.2818,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
]
}
}
},
{
"fullUrl" : "urn:uuid:c75df5fb-e962-43a6-9dd3-c6682da10a7e",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "c75df5fb-e962-43a6-9dd3-c6682da10a7e",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_c75df5fb-e962-43a6-9dd3-c6682da10a7e\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition c75df5fb-e962-43a6-9dd3-c6682da10a7e</b></p><a name=\"c75df5fb-e962-43a6-9dd3-c6682da10a7e\"> </a><a name=\"hcc75df5fb-e962-43a6-9dd3-c6682da10a7e\"> </a><a name=\"c75df5fb-e962-43a6-9dd3-c6682da10a7e-en-US\"> </a><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}\">USP-NF</span></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov GGO4Y809LO}\">GGO4Y809LO</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>METACRESOL</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></td></tr></table></div>"
},
"classification" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
],
"grade" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134006",
"display" : "USP-NF"
}
]
}
],
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "GGO4Y809LO"
}
]
}
}
],
"name" : [
{
"name" : "METACRESOL",
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
}
],
"sourceMaterial" : {
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
}
}
},
{
"fullUrl" : "urn:uuid:d0574580-7694-4a36-8a27-5bdbccfc5557",
"resource" : {
"resourceType" : "Ingredient",
"id" : "d0574580-7694-4a36-8a27-5bdbccfc5557",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-dp-ingredient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"Ingredient_d0574580-7694-4a36-8a27-5bdbccfc5557\"> </a><p class=\"res-header-id\"><b>Generated Narrative: Ingredient d0574580-7694-4a36-8a27-5bdbccfc5557</b></p><a name=\"d0574580-7694-4a36-8a27-5bdbccfc5557\"> </a><a name=\"hcd0574580-7694-4a36-8a27-5bdbccfc5557\"> </a><a name=\"d0574580-7694-4a36-8a27-5bdbccfc5557-en-US\"> </a><p><b>identifier</b>: WaterBFIngredient</p><p><b>status</b>: Active</p><p><b>role</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C42637}\">Inactive Ingredient</span></p><blockquote><p><b>substance</b></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Reference</b></td></tr><tr><td style=\"display: none\">*</td><td><a href=\"Bundle-a242b79e-b706-49d3-93ba-b4364ab2baa3.html#urn-uuid-c4e5b7c6-2e52-48e3-813b-d227cf29329b\">Bundle: identifier = UUID:a242b79e-b706-49d3-93ba-b4364ab2baa3; type = document; timestamp = 2024-07-01 12:34:56+0000</a></td></tr></table><blockquote><p><b>strength</b></p><p><b>concentration</b>: 50.75 kilogram<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM codekg = 'kg')</span></p></blockquote><blockquote><p><b>strength</b></p><p><b>concentration</b>: 95.3572 percent<span style=\"background: LightGoldenRodYellow\"> (Details: UCUM code% = '%')</span></p></blockquote></blockquote></div>"
},
"identifier" : {
"value" : "WaterBFIngredient"
},
"status" : "active",
"role" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C42637",
"display" : "Inactive Ingredient"
}
]
},
"substance" : {
"code" : {
"reference" : {
"reference" : "urn:uuid:c4e5b7c6-2e52-48e3-813b-d227cf29329b"
}
},
"strength" : [
{
"concentrationQuantity" : {
"value" : 50.75,
"unit" : "kilogram",
"system" : "http://unitsofmeasure.org",
"code" : "kg"
}
},
{
"concentrationQuantity" : {
"value" : 95.3572,
"unit" : "percent",
"system" : "http://unitsofmeasure.org",
"code" : "%"
}
}
]
}
}
},
{
"fullUrl" : "urn:uuid:c4e5b7c6-2e52-48e3-813b-d227cf29329b",
"resource" : {
"resourceType" : "SubstanceDefinition",
"id" : "c4e5b7c6-2e52-48e3-813b-d227cf29329b",
"meta" : {
"profile" : [
🔗 "http://hl7.org/fhir/us/pq-cmc-fda/StructureDefinition/pqcmc-excipient"
]
},
"text" : {
"status" : "generated",
"div" : "<div xmlns=\"http://www.w3.org/1999/xhtml\"><a name=\"SubstanceDefinition_c4e5b7c6-2e52-48e3-813b-d227cf29329b\"> </a><p class=\"res-header-id\"><b>Generated Narrative: SubstanceDefinition c4e5b7c6-2e52-48e3-813b-d227cf29329b</b></p><a name=\"c4e5b7c6-2e52-48e3-813b-d227cf29329b\"> </a><a name=\"hcc4e5b7c6-2e52-48e3-813b-d227cf29329b\"> </a><a name=\"c4e5b7c6-2e52-48e3-813b-d227cf29329b-en-US\"> </a><p><b>classification</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></p><p><b>grade</b>: <span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C134006}\">USP-NF</span></p><h3>Codes</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Code</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://fdasis.nlm.nih.gov 059QF0KO0R}\">059QF0KO0R</span></td></tr></table><h3>Names</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Name</b></td><td><b>Type</b></td><td><b>Preferred</b></td></tr><tr><td style=\"display: none\">*</td><td>WATER</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C203355}\">GSRS Preferred Term</span></td><td>true</td></tr></table><h3>SourceMaterials</h3><table class=\"grid\"><tr><td style=\"display: none\">-</td><td><b>Type</b></td></tr><tr><td style=\"display: none\">*</td><td><span title=\"Codes:{http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl C48807}\">Chemical</span></td></tr></table></div>"
},
"classification" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
],
"grade" : [
{
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C134006",
"display" : "USP-NF"
}
]
}
],
"code" : [
{
"code" : {
"coding" : [
{
"system" : "http://fdasis.nlm.nih.gov",
"code" : "059QF0KO0R"
}
]
}
}
],
"name" : [
{
"name" : "WATER",
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C203355",
"display" : "GSRS Preferred Term"
}
]
},
"preferred" : true
}
],
"sourceMaterial" : {
"type" : {
"coding" : [
{
"system" : "http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl",
"code" : "C48807",
"display" : "Chemical"
}
]
}
}
}
}
]
}
IG © 2021+ HL7 International / Biomedical Research and Regulation. Package hl7.fhir.us.pq-cmc-fda#2.0.0-ballot based on FHIR 5.0.0. Generated 2024-12-04
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